{ "FullStudy":{ "Rank":218136, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01512264", "OrgStudyIdInfo":{ "OrgStudyId":"R01HD068488", "OrgStudyIdType":"U.S. NIH Grant/Contract", "OrgStudyIdLink":"https://projectreporter.nih.gov/reporterapi.cfm?PROJECTNUM=R01HD068488&Fy=all" }, "Organization":{ "OrgFullName":"University of Alabama at Birmingham", "OrgClass":"OTHER" }, "BriefTitle":"Post-Stroke Aphasia and Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment Study", "OfficialTitle":"Post-Stroke Aphasia and rTMS Treatment Study (PART)", "Acronym":"PART" }, "StatusModule":{ "StatusVerifiedDate":"December 2019", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"July 20, 2018", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"July 20, 2018", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 10, 2012", "StudyFirstSubmitQCDate":"January 13, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 19, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"June 7, 2019", "ResultsFirstSubmitQCDate":"July 25, 2019", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"August 16, 2019", "ResultsFirstPostDateType":"Actual" }, "LastUpdateSubmitDate":"December 11, 2019", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"December 19, 2019", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Jerzy P Szaflarski", "ResponsiblePartyInvestigatorTitle":"Professor", "ResponsiblePartyInvestigatorAffiliation":"University of Alabama at Birmingham" }, "LeadSponsor":{ "LeadSponsorName":"University of Alabama at Birmingham", "LeadSponsorClass":"OTHER" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)", "CollaboratorClass":"NIH" },{ "CollaboratorName":"National Institute on Deafness and Other Communication Disorders (NIDCD)", "CollaboratorClass":"NIH" } ] } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"In this study the investigators will examine the efficacy of navigated excitatory repetitive transcranial magnetic stimulation (nerTMS) for the treatment of post stroke aphasia. The investigators expect that this new types of rehabilitation (nerTMS) will help patients with aphasia return to their lives as they were prior to the stroke.", "DetailedDescription":"Aphasia after stroke is associated with high mortality, significant motor impairment, and severe limitations in social participation. During the past decade, therapies administered by stroke teams have made great strides to limit the motor impairments caused by stroke. Unfortunately, progress in aphasia rehabilitation has not experienced the same rapid advancement. This proposal is based on preliminary evidence from our recently completed pilot study which showed that navigated excitatory repetitive transcranial magnetic stimulation (nerTMS) targeted to residual activity in the affected hemisphere has a significant beneficial effect on post-stroke aphasia recovery.1 The main aim of this study is to conduct a double-blind, sham-controlled, dose-response nerTMS treatment trial in subjects with chronic aphasia. By conducting this comparative trial, we will provide clinical (qualitative and quantitative) and imaging evidence that nerTMS improves language function after stroke when compared to standard treatment (ST). The findings will have implications for patients with post-stroke aphasia in that once the study is completed and the results are available, rehabilitation specialists may be able to change their practice pattern by offering an additional tool to aid patients in recovering their language skills with improved participation in society and enhanced quality of life.\n\nTo fill the gap in our therapeutic arsenal for aphasia, we propose a study with the following specific aims: (1) to determine the comparative efficacy and optimal dosing of nerTMS on aphasia recovery using a randomized, double-blind, sham-controlled study design. Subjects (15/group) will be randomly assigned to 4 treatment groups: (a) 3 weeks of nerTMS, (b) 1 week of ST + 2 weeks of nerTMS, (c) 2 weeks of ST +1 week of nerTMS, or (d) 3 weeks of ST (control group). This design will allow systematic evaluation of the efficacy of nerTMS and will determine its most optimal dose for language recovery. Short- and long-term outcomes will be evaluated with aphasia testing (AT) and fMRI; (2) to use fMRI to assess changes in language lateralization in response to nerTMS. We will examine the relationship between the degree of pre-nerTMS language lateralization (fMRI) with the post-nerTMS language outcomes (AT) and determine whether fMRI language lateralization can predict AT performance following nerTMS targeted to the left middle cerebral artery (LMCA) stroke areas." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Aphasia", "Stroke" ] }, "KeywordList":{ "Keyword":[ "Aphasia", "Stroke", "functional Magnetic resonance imaging", "fMRI", "Language recovery after stroke", "constraint induced aphasia therapy", "CIAT", "Repetitive transcranial magnetic stimulation", "rTMS" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Quadruple", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Care Provider", "Investigator", "Outcomes Assessor" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"28", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"rTMS", "ArmGroupType":"Experimental", "ArmGroupDescription":"3 weeks of nerTMS", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Device: Magstim SuperRapid" ] } },{ "ArmGroupLabel":"1 week of Sham Treatment + 2 weeks of nerTMS", "ArmGroupType":"Sham Comparator", "ArmGroupDescription":"1 week of Sham Treatment + 2 weeks of nerTMS", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Device: Magstim SuperRapid" ] } },{ "ArmGroupLabel":"2 weeks of Sham Treatment +1 week of nerTMS", "ArmGroupType":"Sham Comparator", "ArmGroupDescription":"2 weeks of Sham Treatment +1 week of nerTMS", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Device: Magstim SuperRapid" ] } },{ "ArmGroupLabel":"Control Group", "ArmGroupType":"Placebo Comparator", "ArmGroupDescription":"3 weeks of Sham Treatment", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Device: Magstim SuperRapid" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Device", "InterventionName":"Magstim SuperRapid", "InterventionDescription":"This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "1 week of Sham Treatment + 2 weeks of nerTMS", "2 weeks of Sham Treatment +1 week of nerTMS", "Control Group", "rTMS" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Repetitive Transcranial Magnetic Stimulation, rTMS" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Aphasia Testing as Evaluated by the Boston Naming Test (BNT) - Baseline", "PrimaryOutcomeDescription":"60-item test of visual confrontation naming for aphasia. In the BNT, subjects are shown line drawings of common objects one at a time and asked to name them orally. Scoring counts the number of spontaneously produced correct responses, the number of cues given, and the number of responses after phonemic cuing and after semantic cuing. The scale for scoring is 0-60 with 0 being no spontaneous correct answers and 60 being all correct answers.", "PrimaryOutcomeTimeFrame":"Baseline: 1 week before the first nerTMS treatment" },{ "PrimaryOutcomeMeasure":"Aphasia Testing as Evaluated by the Boston Naming Test (BNT) - Immediate Follow-Up", "PrimaryOutcomeDescription":"60-item test of visual confrontation naming for aphasia. In the BNT, subjects are shown line drawings of common objects one at a time and asked to name them orally. Scoring counts the number of spontaneously produced correct responses, the number of cues given, and the number of responses after phonemic cuing and after semantic cuing. The scale for scoring is 0-60 with 0 being no spontaneous correct answers and 60 being all correct answers.", "PrimaryOutcomeTimeFrame":"within 1 week post treatment" },{ "PrimaryOutcomeMeasure":"Aphasia Testing as Evaluated by the Boston Naming Test (BNT) - Long Term Follow-up", "PrimaryOutcomeDescription":"60-item test of visual confrontation naming for aphasia. In the BNT, subjects are shown line drawings of common objects one at a time and asked to name them orally. Scoring counts the number of spontaneously produced correct responses, the number of cues given, and the number of responses after phonemic cuing and after semantic cuing. The scale for scoring is 0-60 with 0 being no spontaneous correct answers and 60 being all correct answers.", "PrimaryOutcomeTimeFrame":"3 months post treatment" },{ "PrimaryOutcomeMeasure":"Aphasia Testing as Evaluated by the Semantic Fluency Test (SFT) - Baseline", "PrimaryOutcomeDescription":"The Semantic Fluency Test is used to assess verbal ability. It is a psychological test where participants produce as many words as possible in a given category for a specified time period. In the SFT participants were given 3 categories (i.e. \"Animals\", \"Fruits\") and asked to produce as many words in that category as they can in 60 seconds. Scoring of the test included the sum of the number of spontaneous words that were generated in each category. This measure does not have a theoretical maximum; however, the more words generated indicates higher verbal ability which can indicate changes related to aphasia.", "PrimaryOutcomeTimeFrame":"1 week before the first nerTMS treatment" },{ "PrimaryOutcomeMeasure":"Aphasia Testing as Evaluated by the Semantic Fluency Test (SFT) - Immediate Follow-up", "PrimaryOutcomeDescription":"The Semantic Fluency Test is used to assess verbal ability. It is a psychological test where participants produce as many words as possible in a given category for a specified time period. In the SFT participants were given 3 categories (i.e. \"Animals\", \"Fruits\") and asked to produce as many words in that category as they can in 60 seconds. Scoring of the test included the sum of the number of spontaneous words that were generated in each category. This measure does not have a theoretical maximum; however, the more words generated indicates higher verbal ability which can indicate changes related to aphasia.", "PrimaryOutcomeTimeFrame":"within 1 week post treatment" },{ "PrimaryOutcomeMeasure":"Aphasia Testing as Evaluated by the Semantic Fluency Test (SFT) - Long Term Follow-up", "PrimaryOutcomeDescription":"The Semantic Fluency Test is used to assess verbal ability. It is a psychological test where participants produce as many words as possible in a given category for a specified time period. In the SFT participants were given 3 categories (i.e. \"Animals\", \"Fruits\") and asked to produce as many words in that category as they can in 60 seconds. Scoring of the test included the sum of the number of spontaneous words that were generated in each category. This measure does not have a theoretical maximum; however, the more words generated indicates higher verbal ability which can indicate changes related to aphasia.", "PrimaryOutcomeTimeFrame":"3 months post treatment" },{ "PrimaryOutcomeMeasure":"Aphasia Testing as Evaluated by the Controlled Word Association Test (COWAT) - Baseline", "PrimaryOutcomeDescription":"The Controlled Word Association Test is also a verbal fluency test. In this test participants produce as many words as possible given a specific letter for a specified time period. In the COWAT participants were given 3 Letters (i.e. \"C\", \"F\", \"L\") and asked to produce as many words that begin with that letter (excluding proper nouns) as they can in 60 seconds. Scoring of the test included the sum of the number of spontaneous words that were generated in each category. This measure does not have a theoretical maximum; however, the more words generated indicates higher verbal ability which can indicate changes related to aphasia.", "PrimaryOutcomeTimeFrame":"1 week before the first nerTMS treatment" },{ "PrimaryOutcomeMeasure":"Aphasia Testing as Evaluated by the Controlled Word Association Test (COWAT) - Immediate Follow-up", "PrimaryOutcomeDescription":"The Controlled Word Association Test is also a verbal fluency test. In this test participants produce as many words as possible given a specific letter for a specified time period. In the COWAT participants were given 3 Letters (i.e. \"C\", \"F\", \"L\") and asked to produce as many words that begin with that letter (excluding proper nouns) as they can in 60 seconds. Scoring of the test included the sum of the number of spontaneous words that were generated in each category. This measure does not have a theoretical maximum; however, the more words generated indicates higher verbal ability which can indicate changes related to aphasia.", "PrimaryOutcomeTimeFrame":"within 1 week post treatment" },{ "PrimaryOutcomeMeasure":"Aphasia Testing as Evaluated by the Controlled Word Association Test (COWAT) - Long Term Follow-up", "PrimaryOutcomeDescription":"The Controlled Word Association Test is also a verbal fluency test. In this test participants produce as many words as possible given a specific letter for a specified time period. In the COWAT participants were given 3 Letters (i.e. \"C\", \"F\", \"L\") and asked to produce as many words that begin with that letter (excluding proper nouns) as they can in 60 seconds. Scoring of the test included the sum of the number of spontaneous words that were generated in each category. This measure does not have a theoretical maximum; however, the more words generated indicates higher verbal ability which can indicate changes related to aphasia.", "PrimaryOutcomeTimeFrame":"3 months post treatment" },{ "PrimaryOutcomeMeasure":"Western Aphasia Battery (WAB) - Baseline", "PrimaryOutcomeDescription":"WAB assesses linguistic skills most frequently affected by aphasia, plus key nonlinguistic skills, and provides differential diagnosis information. Adaptable to various administration settings from hospital room to clinic, it provides a baseline level of performance to measure change over time.The scoring provides two main totals, in addition to the subscale scores. These are the Aphasia Quotient (AQ) score and Cortical Quotient (CQ) score. AQ can essentially be thought of as a measure of language ability, whilst CQ is a more general measure of intellectual ability and includes all the subscales. Administration of the Western Aphasia Battery (WAB) yields a total score termed the Aphasia Quotient (AQ), which is said to reflect the severity of the spoken language deficit in aphasia. This score is a weighted composite of performance on 10 separate WAB subtests. Scores rate severity as follows: 0-25 is very severe, 26-50 is severe, 51-75 is moderate, and 76-above is mild.", "PrimaryOutcomeTimeFrame":"Baseline: 1 week before the first nerTMS treatment" },{ "PrimaryOutcomeMeasure":"Western Aphasia Battery (WAB) - Immediate Follow-Up", "PrimaryOutcomeDescription":"WAB assesses linguistic skills most frequently affected by aphasia, plus key nonlinguistic skills, and provides differential diagnosis information. Adaptable to various administration settings from hospital room to clinic, it provides a baseline level of performance to measure change over time.The scoring provides two main totals, in addition to the subscale scores. These are the Aphasia Quotient (AQ) score and Cortical Quotient (CQ) score. AQ can essentially be thought of as a measure of language ability, whilst CQ is a more general measure of intellectual ability and includes all the subscales. Administration of the Western Aphasia Battery (WAB) yields a total score termed the Aphasia Quotient (AQ), which is said to reflect the severity of the spoken language deficit in aphasia. This score is a weighted composite of performance on 10 separate WAB subtests. Scores rate severity as follows: 0-25 is very severe, 26-50 is severe, 51-75 is moderate, and 76-above is mild.", "PrimaryOutcomeTimeFrame":"within 1 week post treatment" },{ "PrimaryOutcomeMeasure":"Western Aphasia Battery (WAB) - Long-Term Follow-Up", "PrimaryOutcomeDescription":"WAB assesses linguistic skills most frequently affected by aphasia, plus key nonlinguistic skills, and provides differential diagnosis information. Adaptable to various administration settings from hospital room to clinic, it provides a baseline level of performance to measure change over time.The scoring provides two main totals, in addition to the subscale scores. These are the Aphasia Quotient (AQ) score and Cortical Quotient (CQ) score. AQ can essentially be thought of as a measure of language ability, whilst CQ is a more general measure of intellectual ability and includes all the subscales. Administration of the Western Aphasia Battery (WAB) yields a total score termed the Aphasia Quotient (AQ), which is said to reflect the severity of the spoken language deficit in aphasia. This score is a weighted composite of performance on 10 separate WAB subtests. Scores rate severity as follows: 0-25 is very severe, 26-50 is severe, 51-75 is moderate, and 76-above is mild.", "PrimaryOutcomeTimeFrame":"3 months post treatment" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Change in Language Laterilazation as Indicated by Neuroimaging Correlates: Frontal Laterality Index (LI) Scores - Baseline", "SecondaryOutcomeDescription":"Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from \"-1\" (or -100%) indicating left-hemispheric lateralization to \"1\" (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB).", "SecondaryOutcomeTimeFrame":"Baseline: 1 week before the first nerTMS treatment" },{ "SecondaryOutcomeMeasure":"Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal Laterality Index (LI) Scores - Immediate Follow-up", "SecondaryOutcomeDescription":"Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from \"-1\" (or -100%) indicating left-hemispheric lateralization to \"1\" (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB).", "SecondaryOutcomeTimeFrame":"within 1 week post treatment" },{ "SecondaryOutcomeMeasure":"Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal Laterality Index (LI) Scores - Long-term Follow Up", "SecondaryOutcomeDescription":"Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from \"-1\" (or -100%) indicating left-hemispheric lateralization to \"1\" (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB).", "SecondaryOutcomeTimeFrame":"3 months post treatment" },{ "SecondaryOutcomeMeasure":"Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal-Parietal Laterality Index (LI) Scores - Baseline", "SecondaryOutcomeDescription":"Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from \"-1\" (or -100%) indicating left-hemispheric lateralization to \"1\" (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB).", "SecondaryOutcomeTimeFrame":"Baseline: 1 week before the first nerTMS treatment" },{ "SecondaryOutcomeMeasure":"Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal-Parietal Laterality Index (LI) Scores - Immediate Follow Up", "SecondaryOutcomeDescription":"Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from \"-1\" (or -100%) indicating left-hemispheric lateralization to \"1\" (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB).", "SecondaryOutcomeTimeFrame":"within 1 week post treatment" },{ "SecondaryOutcomeMeasure":"Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal-Parietal Laterality Index (LI) Scores - Long-term Follow Up", "SecondaryOutcomeDescription":"Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from \"-1\" (or -100%) indicating left-hemispheric lateralization to \"1\" (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB).", "SecondaryOutcomeTimeFrame":"3 months post treatment" },{ "SecondaryOutcomeMeasure":"Change in Language Lateralization as Indicated by Neuroimaging Correlates: Cerebellum Laterality Index (LI) Scores - Baseline", "SecondaryOutcomeDescription":"Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from \"-1\" (or -100%) indicating left-hemispheric lateralization to \"1\" (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB).", "SecondaryOutcomeTimeFrame":"Baseline: 1 week before the first nerTMS treatment" },{ "SecondaryOutcomeMeasure":"Change in Language Lateralization as Indicated by Neuroimaging Correlates: Cerebellum Laterality Index (LI) Scores - Immediate Follow Up", "SecondaryOutcomeDescription":"Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from \"-1\" (or -100%) indicating left-hemispheric lateralization to \"1\" (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB).", "SecondaryOutcomeTimeFrame":"within 1 week post treatment" },{ "SecondaryOutcomeMeasure":"Change in Language Lateralization as Indicated by Neuroimaging Correlates: Cerebellum Laterality Index (LI) Scores - Long-term Follow Up", "SecondaryOutcomeDescription":"Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from \"-1\" (or -100%) indicating left-hemispheric lateralization to \"1\" (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB).", "SecondaryOutcomeTimeFrame":"3 months post treatment" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nAge ≥ 18 years\nLMCA stroke as indicated by the presence of aphasia and MRI lesion in the LMCA distribution\nModerate aphasia (Token Test score between 40th and 90th percentile)\nFluency in English\nProvision of written informed consent by the patient and/or the next of kin\n\nExclusion Criteria:\n\nAge less than 18 years\nUnderlying degenerative or metabolic disorder or supervening medical illness\nSevere depression or other psychiatric disorder\nPositive pregnancy test in women of childbearing age\nAny contraindication to MRI/fMRI at 3T (i.e., intracranial metal implants, claustrophobia)\nAny contraindication to nerTMS (e.g., seizures or epilepsy)", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Jerzy P Szaflarski, MD, PhD", "OverallOfficialAffiliation":"University of Alabama at Birmingham", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"University of Alabama at Birmingham", "LocationCity":"Birmingham", "LocationState":"Alabama", "LocationZip":"35294", "LocationCountry":"United States" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"rTMS", "FlowGroupDescription":"3 weeks of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "FlowGroupId":"FG001", "FlowGroupTitle":"1 Week of Sham Treatment + 2 Weeks of nerTMS", "FlowGroupDescription":"1 week of Sham Treatment + 2 weeks of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "FlowGroupId":"FG002", "FlowGroupTitle":"2 Weeks of Sham Treatment +1 Week of nerTMS", "FlowGroupDescription":"2 weeks of Sham Treatment +1 week of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "FlowGroupId":"FG003", "FlowGroupTitle":"Control Group", "FlowGroupDescription":"3 weeks of Sham Treatment\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"7" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"7" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"7" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"7" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"7" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"7" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"7" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"6" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"1" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Lost to Follow-up", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"1" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"rTMS", "BaselineGroupDescription":"3 weeks of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"1 Week of Sham Treatment + 2 Weeks of nerTMS", "BaselineGroupDescription":"1 week of Sham Treatment + 2 weeks of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"2 Weeks of Sham Treatment +1 Week of nerTMS", "BaselineGroupDescription":"2 weeks of Sham Treatment +1 week of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "BaselineGroupId":"BG003", "BaselineGroupTitle":"Control Group", "BaselineGroupDescription":"3 weeks of Sham Treatment\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "BaselineGroupId":"BG004", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"7" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"7" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"7" },{ "BaselineDenomCountGroupId":"BG003", "BaselineDenomCountValue":"7" },{ "BaselineDenomCountGroupId":"BG004", "BaselineDenomCountValue":"28" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Categorical", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineMeasureCalculatePct":"No", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"<=18 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"0" } ] } },{ "BaselineCategoryTitle":"Between 18 and 65 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"6" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"6" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"3" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"7" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"22" } ] } },{ "BaselineCategoryTitle":">=65 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"4" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"6" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineMeasureCalculatePct":"No", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"3" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"3" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"8" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"4" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"6" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"4" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"6" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"20" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Race (NIH/OMB)", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineMeasureCalculatePct":"No", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"American Indian or Alaska Native", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG004", 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"BaselineCategoryTitle":"Black or African American", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"3" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"9" } ] } },{ "BaselineCategoryTitle":"White", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"5" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"5" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"4" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"4" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"18" } ] } },{ "BaselineCategoryTitle":"More than one race", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"0" } ] } },{ "BaselineCategoryTitle":"Unknown or Not Reported", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"0" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Region of Enrollment", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"United States", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"7" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"7" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"6" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"7" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"27" } ] } } ] } },{ "BaselineClassTitle":"India", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"1" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Aphasia Testing as Evaluated by the Boston Naming Test (BNT) - Baseline", "OutcomeMeasureDescription":"60-item test of visual confrontation naming for aphasia. In the BNT, subjects are shown line drawings of common objects one at a time and asked to name them orally. Scoring counts the number of spontaneously produced correct responses, the number of cues given, and the number of responses after phonemic cuing and after semantic cuing. The scale for scoring is 0-60 with 0 being no spontaneous correct answers and 60 being all correct answers.", "OutcomeMeasurePopulationDescription":"1 participant from control group was unable to be analyzed due to loss of follow up.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"units on a scale", "OutcomeMeasureTimeFrame":"Baseline: 1 week before the first nerTMS treatment", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"rTMS", "OutcomeGroupDescription":"3 weeks of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"1 Week of Sham Treatment + 2 Weeks of nerTMS", "OutcomeGroupDescription":"1 week of Sham Treatment + 2 weeks of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"2 Weeks of Sham Treatment +1 Week of nerTMS", "OutcomeGroupDescription":"2 weeks of Sham Treatment +1 week of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Control Group", "OutcomeGroupDescription":"3 weeks of Sham Treatment\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"6" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"33.43", "OutcomeMeasurementSpread":"17.67" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"18.29", "OutcomeMeasurementSpread":"18.94" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"28.57", "OutcomeMeasurementSpread":"24.21" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"41.00", "OutcomeMeasurementSpread":"13.56" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Aphasia Testing as Evaluated by the Boston Naming Test (BNT) - Immediate Follow-Up", "OutcomeMeasureDescription":"60-item test of visual confrontation naming for aphasia. In the BNT, subjects are shown line drawings of common objects one at a time and asked to name them orally. Scoring counts the number of spontaneously produced correct responses, the number of cues given, and the number of responses after phonemic cuing and after semantic cuing. The scale for scoring is 0-60 with 0 being no spontaneous correct answers and 60 being all correct answers.", "OutcomeMeasurePopulationDescription":"1 participant from control group was unable to be analyzed due to loss of follow up.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"units on a scale", "OutcomeMeasureTimeFrame":"within 1 week post treatment", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"rTMS", "OutcomeGroupDescription":"3 weeks of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"1 Week of Sham Treatment + 2 Weeks of nerTMS", "OutcomeGroupDescription":"1 week of Sham Treatment + 2 weeks of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"2 Weeks of Sham Treatment +1 Week of nerTMS", "OutcomeGroupDescription":"2 weeks of Sham Treatment +1 week of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Control Group", "OutcomeGroupDescription":"3 weeks of Sham Treatment\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"6" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"42.43", "OutcomeMeasurementSpread":"18.32" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"24.86", "OutcomeMeasurementSpread":"22.23" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"30.86", "OutcomeMeasurementSpread":"24.65" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"48.83", "OutcomeMeasurementSpread":"10.26" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000" ] }, "OutcomeAnalysisGroupDescription":"paired t- test between time point 1 and time point 4 for the rTMS group and BNT test was calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -1.58.", "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"0.006", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG001" ] }, "OutcomeAnalysisGroupDescription":"paired t- test between time point 1 and time point 4 for the1 week of Sham Treatment + 2 weeks of nerTMS group and BNT test was calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -1.27.", "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"0.015", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG002" ] }, "OutcomeAnalysisGroupDescription":"paired t- test between time point 1 and time point 4 for the 2 weeks of Sham Treatment + 1 week of nerTMS group and BNT test was calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.54.", "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"0.203", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG003" ] }, "OutcomeAnalysisGroupDescription":"paired t- test between time point 1 and time point 4 for the control group and BNT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -1.63.", "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"0.010", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided" } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Aphasia Testing as Evaluated by the Boston Naming Test (BNT) - Long Term Follow-up", "OutcomeMeasureDescription":"60-item test of visual confrontation naming for aphasia. In the BNT, subjects are shown line drawings of common objects one at a time and asked to name them orally. Scoring counts the number of spontaneously produced correct responses, the number of cues given, and the number of responses after phonemic cuing and after semantic cuing. The scale for scoring is 0-60 with 0 being no spontaneous correct answers and 60 being all correct answers.", "OutcomeMeasurePopulationDescription":"1 participant from control group was unable to be analyzed due to loss of follow up.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"units on a scale", "OutcomeMeasureTimeFrame":"3 months post treatment", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"rTMS", "OutcomeGroupDescription":"3 weeks of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"1 Week of Sham Treatment + 2 Weeks of nerTMS", "OutcomeGroupDescription":"1 week of Sham Treatment + 2 weeks of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"2 Weeks of Sham Treatment +1 Week of nerTMS", "OutcomeGroupDescription":"2 weeks of Sham Treatment +1 week of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Control Group", "OutcomeGroupDescription":"3 weeks of Sham Treatment\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"6" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"38.50", "OutcomeMeasurementSpread":"20.44" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"15.67", "OutcomeMeasurementSpread":"17.69" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"25.17", "OutcomeMeasurementSpread":"24.69" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"47.60", "OutcomeMeasurementSpread":"9.56" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000" ] }, "OutcomeAnalysisGroupDescription":"paired t- test between time point 1 and time point 5 for the rTMS group and BNT test was calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.54.", "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"0.410", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG001" ] }, "OutcomeAnalysisGroupDescription":"paired t- test between time point 1 and time point 5 for 1 week of Sham Treatment + 2 weeks of nerTMS group and BNT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 0.57.", "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"0.618", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG002" ] }, "OutcomeAnalysisGroupDescription":"paired t- test between time point 1 and time point 5 for 2 weeks of Sham Treatment + 1 week of nerTMS group and BNT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 1.31.", "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"1.000", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG003" ] }, "OutcomeAnalysisGroupDescription":"paired t- test between time point 1 and time point 5 for the control group and BNT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 4.35.", "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"0.019", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided" } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Aphasia Testing as Evaluated by the Semantic Fluency Test (SFT) - Baseline", "OutcomeMeasureDescription":"The Semantic Fluency Test is used to assess verbal ability. It is a psychological test where participants produce as many words as possible in a given category for a specified time period. In the SFT participants were given 3 categories (i.e. \"Animals\", \"Fruits\") and asked to produce as many words in that category as they can in 60 seconds. Scoring of the test included the sum of the number of spontaneous words that were generated in each category. This measure does not have a theoretical maximum; however, the more words generated indicates higher verbal ability which can indicate changes related to aphasia.", "OutcomeMeasurePopulationDescription":"1 participant from control group was unable to be analyzed due to loss of follow up.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"words generated", "OutcomeMeasureTimeFrame":"1 week before the first nerTMS treatment", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"rTMS", "OutcomeGroupDescription":"3 weeks of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"1 Week of Sham Treatment + 2 Weeks of nerTMS", "OutcomeGroupDescription":"1 week of Sham Treatment + 2 weeks of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"2 Weeks of Sham Treatment +1 Week of nerTMS", "OutcomeGroupDescription":"2 weeks of Sham Treatment +1 week of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Control Group", "OutcomeGroupDescription":"3 weeks of Sham Treatment\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"6" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"16.29", "OutcomeMeasurementSpread":"13.01" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"8.00", "OutcomeMeasurementSpread":"7.66" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"9.57", "OutcomeMeasurementSpread":"9.03" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"25.50", "OutcomeMeasurementSpread":"8.92" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Aphasia Testing as Evaluated by the Semantic Fluency Test (SFT) - Immediate Follow-up", "OutcomeMeasureDescription":"The Semantic Fluency Test is used to assess verbal ability. It is a psychological test where participants produce as many words as possible in a given category for a specified time period. In the SFT participants were given 3 categories (i.e. \"Animals\", \"Fruits\") and asked to produce as many words in that category as they can in 60 seconds. Scoring of the test included the sum of the number of spontaneous words that were generated in each category. This measure does not have a theoretical maximum; however, the more words generated indicates higher verbal ability which can indicate changes related to aphasia.", "OutcomeMeasurePopulationDescription":"1 participant from control group was unable to be analyzed due to loss of follow up.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"units on a scale", "OutcomeMeasureTimeFrame":"within 1 week post treatment", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"rTMS", "OutcomeGroupDescription":"3 weeks of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"1 Week of Sham Treatment + 2 Weeks of nerTMS", "OutcomeGroupDescription":"1 week of Sham Treatment + 2 weeks of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"2 Weeks of Sham Treatment +1 Week of nerTMS", "OutcomeGroupDescription":"2 weeks of Sham Treatment +1 week of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Control Group", "OutcomeGroupDescription":"3 weeks of Sham Treatment\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"6" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"18.86", "OutcomeMeasurementSpread":"13.43" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"8.86", "OutcomeMeasurementSpread":"8.76" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"11.14", "OutcomeMeasurementSpread":"10.11" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"29.17", "OutcomeMeasurementSpread":"9.58" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000" ] }, "OutcomeAnalysisGroupDescription":"paired t- test between time point 1 and time point 4 for the rTMS group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.69.", "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"0.118", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG001" ] }, "OutcomeAnalysisGroupDescription":"paired t- test between time point 1 and time point 4 for the 1 week of Sham Treatment + 2 weeks of nerTMS group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.28.", "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"0.482", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG002" ] }, "OutcomeAnalysisGroupDescription":"paired t- test between time point 1 and time point 4 for the 2 weeks of Sham Treatment +1 week of nerTMS group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.37.", "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"0.368", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG003" ] }, "OutcomeAnalysisGroupDescription":"paired t- test between time point 1 and time point 4 for the control group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.70.", "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"0.147", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided" } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Aphasia Testing as Evaluated by the Semantic Fluency Test (SFT) - Long Term Follow-up", "OutcomeMeasureDescription":"The Semantic Fluency Test is used to assess verbal ability. It is a psychological test where participants produce as many words as possible in a given category for a specified time period. In the SFT participants were given 3 categories (i.e. \"Animals\", \"Fruits\") and asked to produce as many words in that category as they can in 60 seconds. Scoring of the test included the sum of the number of spontaneous words that were generated in each category. This measure does not have a theoretical maximum; however, the more words generated indicates higher verbal ability which can indicate changes related to aphasia.", "OutcomeMeasurePopulationDescription":"1 participant from control group was unable to be analyzed due to loss of follow up.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"words generated", "OutcomeMeasureTimeFrame":"3 months post treatment", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"rTMS", "OutcomeGroupDescription":"3 weeks of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"1 Week of Sham Treatment + 2 Weeks of nerTMS", "OutcomeGroupDescription":"1 week of Sham Treatment + 2 weeks of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"2 Weeks of Sham Treatment +1 Week of nerTMS", "OutcomeGroupDescription":"2 weeks of Sham Treatment +1 week of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Control Group", "OutcomeGroupDescription":"3 weeks of Sham Treatment\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"6" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"19.00", "OutcomeMeasurementSpread":"12.86" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"7.50", "OutcomeMeasurementSpread":"8.87" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"9.83", "OutcomeMeasurementSpread":"9.39" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"30.40", "OutcomeMeasurementSpread":"5.32" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000" ] }, "OutcomeAnalysisGroupDescription":"paired t- test between time point 1 and time point 5 for the rTMS group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.54.", "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"0.410", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG001" ] }, "OutcomeAnalysisGroupDescription":"paired t- test between time point 1 and time point 5 for the 1 week of Sham Treatment + 2 weeks of nerTMS group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 0.25.", "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"0.695", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG002" ] }, "OutcomeAnalysisGroupDescription":"paired t- test between time point 1 and time point 5 for the 2 weeks of Sham Treatment +1 week of nerTMS group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.25.", "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"0.175", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG003" ] }, "OutcomeAnalysisGroupDescription":"paired t- test between time point 1 and time point 5 for the control group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.60.", "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"0.518", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided" } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Aphasia Testing as Evaluated by the Controlled Word Association Test (COWAT) - Baseline", "OutcomeMeasureDescription":"The Controlled Word Association Test is also a verbal fluency test. In this test participants produce as many words as possible given a specific letter for a specified time period. In the COWAT participants were given 3 Letters (i.e. \"C\", \"F\", \"L\") and asked to produce as many words that begin with that letter (excluding proper nouns) as they can in 60 seconds. Scoring of the test included the sum of the number of spontaneous words that were generated in each category. This measure does not have a theoretical maximum; however, the more words generated indicates higher verbal ability which can indicate changes related to aphasia.", "OutcomeMeasurePopulationDescription":"1 participant from control group was unable to be analyzed due to loss of follow up.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"words generated", "OutcomeMeasureTimeFrame":"1 week before the first nerTMS treatment", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"rTMS", "OutcomeGroupDescription":"3 weeks of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"1 Week of Sham Treatment + 2 Weeks of nerTMS", "OutcomeGroupDescription":"1 week of Sham Treatment + 2 weeks of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"2 Weeks of Sham Treatment +1 Week of nerTMS", "OutcomeGroupDescription":"2 weeks of Sham Treatment +1 week of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Control Group", "OutcomeGroupDescription":"3 weeks of Sham Treatment\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"6" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"9.29", "OutcomeMeasurementSpread":"8.14" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"4.43", "OutcomeMeasurementSpread":"6.24" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"4.86", "OutcomeMeasurementSpread":"3.98" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"9.33", "OutcomeMeasurementSpread":"5.68" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Aphasia Testing as Evaluated by the Controlled Word Association Test (COWAT) - Immediate Follow-up", "OutcomeMeasureDescription":"The Controlled Word Association Test is also a verbal fluency test. In this test participants produce as many words as possible given a specific letter for a specified time period. In the COWAT participants were given 3 Letters (i.e. \"C\", \"F\", \"L\") and asked to produce as many words that begin with that letter (excluding proper nouns) as they can in 60 seconds. Scoring of the test included the sum of the number of spontaneous words that were generated in each category. This measure does not have a theoretical maximum; however, the more words generated indicates higher verbal ability which can indicate changes related to aphasia.", "OutcomeMeasurePopulationDescription":"1 participant from control group was unable to be analyzed due to loss of follow up.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"words generated", "OutcomeMeasureTimeFrame":"within 1 week post treatment", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"rTMS", "OutcomeGroupDescription":"3 weeks of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"1 Week of Sham Treatment + 2 Weeks of nerTMS", "OutcomeGroupDescription":"1 week of Sham Treatment + 2 weeks of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"2 Weeks of Sham Treatment +1 Week of nerTMS", "OutcomeGroupDescription":"2 weeks of Sham Treatment +1 week of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Control Group", "OutcomeGroupDescription":"3 weeks of Sham Treatment\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"6" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"12.43", "OutcomeMeasurementSpread":"10.13" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"5.43", "OutcomeMeasurementSpread":"5.53" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"5.00", "OutcomeMeasurementSpread":"5.35" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"10.17", "OutcomeMeasurementSpread":"5.56" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000" ] }, "OutcomeAnalysisGroupDescription":"paired t- test between time point 1 and time point 4 for the rTMS group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.71.", "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"0.109", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG001" ] }, "OutcomeAnalysisGroupDescription":"paired t- test between time point 1 and time point 4 for the 1 week of Sham Treatment + 2 weeks of nerTMS group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.28.", "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"0.485", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG002" ] }, "OutcomeAnalysisGroupDescription":"paired t- test between time point 1 and time point 4 for the 2 weeks of Sham Treatment +1 week of nerTMS group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.07.", "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"0.864", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG003" ] }, "OutcomeAnalysisGroupDescription":"paired t- test between time point 1 and time point 4 for the control group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.43.", "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"0.341", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided" } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Aphasia Testing as Evaluated by the Controlled Word Association Test (COWAT) - Long Term Follow-up", "OutcomeMeasureDescription":"The Controlled Word Association Test is also a verbal fluency test. In this test participants produce as many words as possible given a specific letter for a specified time period. In the COWAT participants were given 3 Letters (i.e. \"C\", \"F\", \"L\") and asked to produce as many words that begin with that letter (excluding proper nouns) as they can in 60 seconds. Scoring of the test included the sum of the number of spontaneous words that were generated in each category. This measure does not have a theoretical maximum; however, the more words generated indicates higher verbal ability which can indicate changes related to aphasia.", "OutcomeMeasurePopulationDescription":"1 participant from control group was unable to be analyzed due to loss of follow up.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"words generated", "OutcomeMeasureTimeFrame":"3 months post treatment", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"rTMS", "OutcomeGroupDescription":"3 weeks of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"1 Week of Sham Treatment + 2 Weeks of nerTMS", "OutcomeGroupDescription":"1 week of Sham Treatment + 2 weeks of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"2 Weeks of Sham Treatment +1 Week of nerTMS", "OutcomeGroupDescription":"2 weeks of Sham Treatment +1 week of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Control Group", "OutcomeGroupDescription":"3 weeks of Sham Treatment\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"6" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"9.67", "OutcomeMeasurementSpread":"8.38" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3.33", "OutcomeMeasurementSpread":"4.18" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"4.67", "OutcomeMeasurementSpread":"5.47" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"12.60", "OutcomeMeasurementSpread":"5.50" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000" ] }, "OutcomeAnalysisGroupDescription":"paired t- test between time point 1 and time point 5 for the rTMS group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.12.", "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"0.899", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG001" ] }, "OutcomeAnalysisGroupDescription":"paired t- test between time point 1 and time point 5 for the 1 week of Sham Treatment + 2 weeks of nerTMS group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 0.19.", "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"0.519", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG002" ] }, "OutcomeAnalysisGroupDescription":"paired t- test between time point 1 and time point 5 for the 2 weeks of Sham Treatment +1 week of nerTMS group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.09.", "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"1.000", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG003" ] }, "OutcomeAnalysisGroupDescription":"paired t- test between time point 1 and time point 5 for the control group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.84.", "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"0.140", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided" } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Western Aphasia Battery (WAB) - Baseline", "OutcomeMeasureDescription":"WAB assesses linguistic skills most frequently affected by aphasia, plus key nonlinguistic skills, and provides differential diagnosis information. Adaptable to various administration settings from hospital room to clinic, it provides a baseline level of performance to measure change over time.The scoring provides two main totals, in addition to the subscale scores. These are the Aphasia Quotient (AQ) score and Cortical Quotient (CQ) score. AQ can essentially be thought of as a measure of language ability, whilst CQ is a more general measure of intellectual ability and includes all the subscales. Administration of the Western Aphasia Battery (WAB) yields a total score termed the Aphasia Quotient (AQ), which is said to reflect the severity of the spoken language deficit in aphasia. This score is a weighted composite of performance on 10 separate WAB subtests. Scores rate severity as follows: 0-25 is very severe, 26-50 is severe, 51-75 is moderate, and 76-above is mild.", "OutcomeMeasurePopulationDescription":"1 participant from control group was unable to be analyzed due to loss of follow up.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"units on a scale", "OutcomeMeasureTimeFrame":"Baseline: 1 week before the first nerTMS treatment", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"rTMS", "OutcomeGroupDescription":"3 weeks of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"1 Week of Sham Treatment + 2 Weeks of nerTMS", "OutcomeGroupDescription":"1 week of Sham Treatment + 2 weeks of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"2 Weeks of Sham Treatment +1 Week of nerTMS", "OutcomeGroupDescription":"2 weeks of Sham Treatment +1 week of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Control Group", "OutcomeGroupDescription":"3 weeks of Sham Treatment\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"6" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"64.21", "OutcomeMeasurementSpread":"33.20" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"54.88", "OutcomeMeasurementSpread":"28.65" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"54.38", "OutcomeMeasurementSpread":"27.41" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"83.05", "OutcomeMeasurementSpread":"12.61" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Western Aphasia Battery (WAB) - Immediate Follow-Up", "OutcomeMeasureDescription":"WAB assesses linguistic skills most frequently affected by aphasia, plus key nonlinguistic skills, and provides differential diagnosis information. Adaptable to various administration settings from hospital room to clinic, it provides a baseline level of performance to measure change over time.The scoring provides two main totals, in addition to the subscale scores. These are the Aphasia Quotient (AQ) score and Cortical Quotient (CQ) score. AQ can essentially be thought of as a measure of language ability, whilst CQ is a more general measure of intellectual ability and includes all the subscales. Administration of the Western Aphasia Battery (WAB) yields a total score termed the Aphasia Quotient (AQ), which is said to reflect the severity of the spoken language deficit in aphasia. This score is a weighted composite of performance on 10 separate WAB subtests. Scores rate severity as follows: 0-25 is very severe, 26-50 is severe, 51-75 is moderate, and 76-above is mild.", "OutcomeMeasurePopulationDescription":"1 participant from control group was unable to be analyzed due to loss of follow up.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"units on a scale", "OutcomeMeasureTimeFrame":"within 1 week post treatment", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"rTMS", "OutcomeGroupDescription":"3 weeks of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"1 Week of Sham Treatment + 2 Weeks of nerTMS", "OutcomeGroupDescription":"1 week of Sham Treatment + 2 weeks of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"2 Weeks of Sham Treatment +1 Week of nerTMS", "OutcomeGroupDescription":"2 weeks of Sham Treatment +1 week of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Control Group", "OutcomeGroupDescription":"3 weeks of Sham Treatment\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"6" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"63.50", "OutcomeMeasurementSpread":"36.56" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"51.52", "OutcomeMeasurementSpread":"27.75" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"57.46", "OutcomeMeasurementSpread":"28.08" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"80.14", "OutcomeMeasurementSpread":"12.43" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000" ] }, "OutcomeAnalysisGroupDescription":"paired t- test between time point 1 and time point 4 for the rTMS group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 0.24.", "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"0.520", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG001" ] }, "OutcomeAnalysisGroupDescription":"paired t- test between time point 1 and time point 4 for the 1 week of Sham Treatment + 2 weeks of nerTMS group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 0.97.", "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"0.800", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG002" ] }, "OutcomeAnalysisGroupDescription":"paired t- test between time point 1 and time point 4 for the 2 weeks of Sham Treatment +1 week of nerTMS group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.68.", "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"0.148", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG003" ] }, "OutcomeAnalysisGroupDescription":"paired t- test between time point 1 and time point 4 for the control group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 0.67.", "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"0.787", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided" } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Western Aphasia Battery (WAB) - Long-Term Follow-Up", "OutcomeMeasureDescription":"WAB assesses linguistic skills most frequently affected by aphasia, plus key nonlinguistic skills, and provides differential diagnosis information. Adaptable to various administration settings from hospital room to clinic, it provides a baseline level of performance to measure change over time.The scoring provides two main totals, in addition to the subscale scores. These are the Aphasia Quotient (AQ) score and Cortical Quotient (CQ) score. AQ can essentially be thought of as a measure of language ability, whilst CQ is a more general measure of intellectual ability and includes all the subscales. Administration of the Western Aphasia Battery (WAB) yields a total score termed the Aphasia Quotient (AQ), which is said to reflect the severity of the spoken language deficit in aphasia. This score is a weighted composite of performance on 10 separate WAB subtests. Scores rate severity as follows: 0-25 is very severe, 26-50 is severe, 51-75 is moderate, and 76-above is mild.", "OutcomeMeasurePopulationDescription":"1 participant from control group was unable to be analyzed due to loss of follow up.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"units on a scale", "OutcomeMeasureTimeFrame":"3 months post treatment", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"rTMS", "OutcomeGroupDescription":"3 weeks of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"1 Week of Sham Treatment + 2 Weeks of nerTMS", "OutcomeGroupDescription":"1 week of Sham Treatment + 2 weeks of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"2 Weeks of Sham Treatment +1 Week of nerTMS", "OutcomeGroupDescription":"2 weeks of Sham Treatment +1 week of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Control Group", "OutcomeGroupDescription":"3 weeks of Sham Treatment\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"6" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"72.42", "OutcomeMeasurementSpread":"31.69" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"47.33", "OutcomeMeasurementSpread":"30.30" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"60.38", "OutcomeMeasurementSpread":"36.24" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"86.93", "OutcomeMeasurementSpread":"7.84" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000" ] }, "OutcomeAnalysisGroupDescription":"paired t- test between time point 1 and time point 5 for the rTMS group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -3.12.", "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"0.239", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG001" ] }, "OutcomeAnalysisGroupDescription":"paired t- test between time point 1 and time point 5 for the 1 week of Sham Treatment + 2 weeks of nerTMS group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 2.71.", "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"0.212", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG002" ] }, "OutcomeAnalysisGroupDescription":"paired t- test between time point 1 and time point 5 for the 2 weeks of Sham Treatment +1 week of nerTMS group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -3.10.", "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"0.120", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG003" ] }, "OutcomeAnalysisGroupDescription":"paired t- test between time point 1 and time point 5 for the control group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -1.14.", "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"0.263", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change in Language Laterilazation as Indicated by Neuroimaging Correlates: Frontal Laterality Index (LI) Scores - Baseline", "OutcomeMeasureDescription":"Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from \"-1\" (or -100%) indicating left-hemispheric lateralization to \"1\" (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB).", "OutcomeMeasurePopulationDescription":"1 participant from control group was unable to be analyzed due to loss of follow up.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"Index score", "OutcomeMeasureTimeFrame":"Baseline: 1 week before the first nerTMS treatment", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"rTMS", "OutcomeGroupDescription":"3 weeks of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"1 Week of Sham Treatment + 2 Weeks of nerTMS", "OutcomeGroupDescription":"1 week of Sham Treatment + 2 weeks of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"2 Weeks of Sham Treatment +1 Week of nerTMS", "OutcomeGroupDescription":"2 weeks of Sham Treatment +1 week of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Control Group", "OutcomeGroupDescription":"3 weeks of Sham Treatment\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"6" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.30", "OutcomeMeasurementSpread":"0.40" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.22", "OutcomeMeasurementSpread":"0.20" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"-0.19", "OutcomeMeasurementSpread":"0.30" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0.13", "OutcomeMeasurementSpread":"0.42" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal Laterality Index (LI) Scores - Immediate Follow-up", "OutcomeMeasureDescription":"Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from \"-1\" (or -100%) indicating left-hemispheric lateralization to \"1\" (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB).", "OutcomeMeasurePopulationDescription":"1 participant from control group was unable to be analyzed due to loss of follow up.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"index score", "OutcomeMeasureTimeFrame":"within 1 week post treatment", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"rTMS", "OutcomeGroupDescription":"3 weeks of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"1 Week of Sham Treatment + 2 Weeks of nerTMS", "OutcomeGroupDescription":"1 week of Sham Treatment + 2 weeks of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"2 Weeks of Sham Treatment +1 Week of nerTMS", "OutcomeGroupDescription":"2 weeks of Sham Treatment +1 week of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Control Group", "OutcomeGroupDescription":"3 weeks of Sham Treatment\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"6" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.02", "OutcomeMeasurementSpread":"0.40" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.09", "OutcomeMeasurementSpread":"0.46" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"-0.09", "OutcomeMeasurementSpread":"0.55" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"-0.01", "OutcomeMeasurementSpread":"0.39" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal Laterality Index (LI) Scores - Long-term Follow Up", "OutcomeMeasureDescription":"Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from \"-1\" (or -100%) indicating left-hemispheric lateralization to \"1\" (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB).", "OutcomeMeasurePopulationDescription":"1 participant from control group was unable to be analyzed due to loss of follow up.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"index score", "OutcomeMeasureTimeFrame":"3 months post treatment", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"rTMS", "OutcomeGroupDescription":"3 weeks of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"1 Week of Sham Treatment + 2 Weeks of nerTMS", "OutcomeGroupDescription":"1 week of Sham Treatment + 2 weeks of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"2 Weeks of Sham Treatment +1 Week of nerTMS", "OutcomeGroupDescription":"2 weeks of Sham Treatment +1 week of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Control Group", "OutcomeGroupDescription":"3 weeks of Sham Treatment\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"6" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.20", "OutcomeMeasurementSpread":"0.41" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.20", "OutcomeMeasurementSpread":"0.36" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0.01", "OutcomeMeasurementSpread":"0.69" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0.20", "OutcomeMeasurementSpread":"0.40" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal-Parietal Laterality Index (LI) Scores - Baseline", "OutcomeMeasureDescription":"Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from \"-1\" (or -100%) indicating left-hemispheric lateralization to \"1\" (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB).", "OutcomeMeasurePopulationDescription":"1 participant from control group was unable to be analyzed due to loss of follow up.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"index score", "OutcomeMeasureTimeFrame":"Baseline: 1 week before the first nerTMS treatment", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"rTMS", "OutcomeGroupDescription":"3 weeks of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"1 Week of Sham Treatment + 2 Weeks of nerTMS", "OutcomeGroupDescription":"1 week of Sham Treatment + 2 weeks of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"2 Weeks of Sham Treatment +1 Week of nerTMS", "OutcomeGroupDescription":"2 weeks of Sham Treatment +1 week of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Control Group", "OutcomeGroupDescription":"3 weeks of Sham Treatment\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"6" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.14", "OutcomeMeasurementSpread":"0.21" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.15", "OutcomeMeasurementSpread":"0.26" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"-0.19", "OutcomeMeasurementSpread":"0.22" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0.10", "OutcomeMeasurementSpread":"0.34" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal-Parietal Laterality Index (LI) Scores - Immediate Follow Up", "OutcomeMeasureDescription":"Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from \"-1\" (or -100%) indicating left-hemispheric lateralization to \"1\" (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB).", "OutcomeMeasurePopulationDescription":"1 participant from control group was unable to be analyzed due to loss of follow up.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"index score", "OutcomeMeasureTimeFrame":"within 1 week post treatment", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"rTMS", "OutcomeGroupDescription":"3 weeks of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"1 Week of Sham Treatment + 2 Weeks of nerTMS", "OutcomeGroupDescription":"1 week of Sham Treatment + 2 weeks of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"2 Weeks of Sham Treatment +1 Week of nerTMS", "OutcomeGroupDescription":"2 weeks of Sham Treatment +1 week of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Control Group", "OutcomeGroupDescription":"3 weeks of Sham Treatment\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"6" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.10", "OutcomeMeasurementSpread":"0.31" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.06", "OutcomeMeasurementSpread":"0.47" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"-0.03", "OutcomeMeasurementSpread":"0.46" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"-0.03", "OutcomeMeasurementSpread":"0.18" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal-Parietal Laterality Index (LI) Scores - Long-term Follow Up", "OutcomeMeasureDescription":"Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from \"-1\" (or -100%) indicating left-hemispheric lateralization to \"1\" (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB).", "OutcomeMeasurePopulationDescription":"1 participant from control group was unable to be analyzed due to loss of follow up.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"index score", "OutcomeMeasureTimeFrame":"3 months post treatment", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"rTMS", "OutcomeGroupDescription":"3 weeks of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"1 Week of Sham Treatment + 2 Weeks of nerTMS", "OutcomeGroupDescription":"1 week of Sham Treatment + 2 weeks of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"2 Weeks of Sham Treatment +1 Week of nerTMS", "OutcomeGroupDescription":"2 weeks of Sham Treatment +1 week of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Control Group", "OutcomeGroupDescription":"3 weeks of Sham Treatment\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"6" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.21", "OutcomeMeasurementSpread":"0.20" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.11", "OutcomeMeasurementSpread":"0.14" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"-0.02", "OutcomeMeasurementSpread":"0.29" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0.23", "OutcomeMeasurementSpread":"0.23" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change in Language Lateralization as Indicated by Neuroimaging Correlates: Cerebellum Laterality Index (LI) Scores - Baseline", "OutcomeMeasureDescription":"Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from \"-1\" (or -100%) indicating left-hemispheric lateralization to \"1\" (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB).", "OutcomeMeasurePopulationDescription":"1 participant from control group was unable to be analyzed due to loss of follow up.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"index score", "OutcomeMeasureTimeFrame":"Baseline: 1 week before the first nerTMS treatment", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"rTMS", "OutcomeGroupDescription":"3 weeks of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"1 Week of Sham Treatment + 2 Weeks of nerTMS", "OutcomeGroupDescription":"1 week of Sham Treatment + 2 weeks of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"2 Weeks of Sham Treatment +1 Week of nerTMS", "OutcomeGroupDescription":"2 weeks of Sham Treatment +1 week of nerTMS\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Control Group", "OutcomeGroupDescription":"3 weeks of Sham Treatment\n\nMagstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"6" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.24", "OutcomeMeasurementSpread":"0.23" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.05", "OutcomeMeasurementSpread":"0.47" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"-0.09", "OutcomeMeasurementSpread":"0.33" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"-0.23", "OutcomeMeasurementSpread":"0.11" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change in Language Lateralization as Indicated by Neuroimaging Correlates: Cerebellum Laterality Index (LI) Scores - Immediate Follow Up", "OutcomeMeasureDescription":"Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from \"-1\" (or -100%) indicating left-hemispheric lateralization to \"1\" (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. 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