{ "FullStudy":{ "Rank":217768, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01517087", "OrgStudyIdInfo":{ "OrgStudyId":"120060" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"12-N-0060" } ] }, "Organization":{ "OrgFullName":"National Institutes of Health Clinical Center (CC)", "OrgClass":"NIH" }, "BriefTitle":"Studying Motor Neuron Tests", "OfficialTitle":"Structural and Functional Brain Imaging Markers of Upper Motor Neuron Function" }, "StatusModule":{ "StatusVerifiedDate":"January 30, 2020", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 9, 2012" }, "StudyFirstSubmitDate":"January 24, 2012", "StudyFirstSubmitQCDate":"January 24, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"February 20, 2020", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"February 21, 2020", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"National Institute of Neurological Disorders and Stroke (NINDS)", "LeadSponsorClass":"NIH" } }, "OversightModule":{}, "DescriptionModule":{ "BriefSummary":"Background:\n\n- People with motor neuron disorders have changes in the parts of the brain that control movement. Some tests that are currently used to study these changes are magnetic resonance imaging (MRI) and transcranial magnetic stimulation (TMS). We don t know if MRI scans and TMS give the same results if done at different times in the same person. Researchers want to see if these tests produce different results if given to healthy adults on two separate occasions.\n\nObjectives:\n\n- To test the reliability of different tests of the brain used to study motor neuron disorders.\n\nEligibility:\n\nHealthy individuals at least 35 years of age who have no history of neurological disorders and take no medications.\nPregnant women may not participate.\n\nDesign:\n\nParticipants will be screened with a medical history and physical exam.\nParticipants will have two testing visits 1 to 6 months apart.\nThe first visit will have three parts. The first part is a neurological exam to test strength, sensation, reflexes, and coordination of movement. The second part will be TMS tests. The third part will involve an MRI scan to study the parts of the brain that control movement.\nAt the second visit, participants will have MRI scanning only.", "DetailedDescription":"Objective\n\nThe objective of the protocol is to determine the test-retest reliability of imaging techniques that measure the structural and functional integrity of the motor cortex in healthy subjects. Our goal is to determine whether such measures are sufficiently reproducible that they may be used to follow disease progression over time in patients with motor neuron disease. A second objective is to obtain age-matched normative data to provide reference values for studies examining the correlation of physiological and clinical measurements of motor function, cognitive testing, and plasma and spinal fluid biomarker measures with disease progression in patients with motor neuron disease.\n\nStudy Population\n\n55 neurologically normal, healthy adults, age 35 or older\n\nDesign\n\nEach subject will undergo several sessions of testing. The first testing session will consist of a clinical examination with measurements of movement speed. Subjects will undergo one session with transcranial magnetic stimulation of the brain, one session of cognitive testing, and three sessions of magnetic resonance imaging of the brain, one to eighteen months apart. Subjects may opt-in for collection of blood and spinal fluid to provide controls for biomarker studies in motor neuron disease patients.\n\nOutcome Measures\n\nThe primary outcome is the test-retest reliability of magnetic resonance imaging measurements of the motor cortex in individual subjects." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Healthy Subjects", "Magnetic Resonance Imaging", "Central Nervous System", "Volunteer", "Neurological Disorder" ] }, "KeywordList":{ "Keyword":[ "Cerebrospinal Fluid", "Magnetic Resonance Spectroscopy", "Transcranial Magnetic Stimulation (TMS)", "Diffusion Tensor Imaging", "Functional Magnetic Resonance Imaging (fMRI)", "Healthy Volunteer", "HV" ] } }, "DesignModule":{ "StudyType":"Observational", "DesignInfo":{ "DesignObservationalModelList":{ "DesignObservationalModel":[ "Cohort" ] }, "DesignTimePerspectiveList":{ "DesignTimePerspective":[ "Prospective" ] } }, "EnrollmentInfo":{ "EnrollmentCount":"47", "EnrollmentType":"Actual" } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Test-retest correlation of MRI measures", "PrimaryOutcomeDescription":"The test-retest reliability will be assessed by calculating the intraclass correlation coefficient (ICC) between the two sessions. An ICC > 0.8 is considered to indicate excellent reliability.", "PrimaryOutcomeTimeFrame":"09/30/2019" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"INCLUSION CRITERIA:\nHealthy adults aged 35 and older\nNo history of a neurological disorder\nAble to give informed consent\n\nEXCLUSION CRITERIA:\n\nTreatment within the preceding week with medications that affect neuronal excitability, such as antidepressants, sedatives, and drugs for epilepsy or migraine.\nChange in blood pressure medications within the preceding week.\nMetal in the body such as pacemakers, implanted pumps or other implanted electronic devices, some types of dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner or shrapnel fragments.\nPregnancy. Women of childbearing potential will undergo urine pregnancy testing before MRI scanning.\nFear of confined spaces.\nSerious medical illness.\nEmployees or staff in the investigator's section.", "HealthyVolunteers":"Accepts Healthy Volunteers", "Gender":"All", "MinimumAge":"35 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] }, "StudyPopulation":"55 neurologically normal, healthy adults, age 35 or older.", "SamplingMethod":"Non-Probability Sample" }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Mary Kay Floeter, M.D.", "OverallOfficialAffiliation":"National Institute of Neurological Disorders and Stroke (NINDS)", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"National Institutes of Health Clinical Center, 9000 Rockville Pike", "LocationCity":"Bethesda", "LocationState":"Maryland", "LocationZip":"20892", "LocationCountry":"United States" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"10496265", "ReferenceType":"background", "ReferenceCitation":"Ellis CM, Simmons A, Jones DK, Bland J, Dawson JM, Horsfield MA, Williams SC, Leigh PN. Diffusion tensor MRI assesses corticospinal tract damage in ALS. Neurology. 1999 Sep 22;53(5):1051-8." },{ "ReferencePMID":"19349603", "ReferenceType":"background", "ReferenceCitation":"Tartaglia MC, Laluz V, Rowe A, Findlater K, Lee DH, Kennedy K, Kramer JH, Strong MJ. Brain atrophy in primary lateral sclerosis. Neurology. 2009 Apr 7;72(14):1236-41. doi: 10.1212/01.wnl.0000345665.75512.f9." },{ "ReferencePMID":"17608909", "ReferenceType":"background", "ReferenceCitation":"Wong JC, Concha L, Beaulieu C, Johnston W, Allen PS, Kalra S. Spatial profiling of the corticospinal tract in amyotrophic lateral sclerosis using diffusion tensor imaging. J Neuroimaging. 2007 Jul;17(3):234-40." },{ "ReferencePMID":"30299161", "ReferenceType":"derived", "ReferenceCitation":"Clark MG, Smallwood Shoukry R, Huang CJ, Danielian LE, Bageac D, Floeter MK. Loss of functional connectivity is an early imaging marker in primary lateral sclerosis. Amyotroph Lateral Scler Frontotemporal Degener. 2018 Nov;19(7-8):562-569. doi: 10.1080/21678421.2018.1517180. Epub 2018 Oct 9." } ] }, "SeeAlsoLinkList":{ "SeeAlsoLink":[ { "SeeAlsoLinkLabel":"NIH Clinical Center Detailed Web Page", "SeeAlsoLinkURL":"https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2012-N-0060.html" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000009422", "ConditionMeshTerm":"Nervous System Diseases" } ] } } } } } }