{ "FullStudy":{ "Rank":217864, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01515839", "OrgStudyIdInfo":{ "OrgStudyId":"ISCAN 001" }, "Organization":{ "OrgFullName":"Amen Clinics, Inc.", "OrgClass":"INDUSTRY" }, "BriefTitle":"Single Photon Emission Computed Tomography (SPECT) Imaging Study of Professional American Football Players", "OfficialTitle":"Brain Single Photon Emission Computed Tomography and Quantitative Electroencephalography In Former NFL Players: A Single-Site Exploratory Pilot Study" }, "StatusModule":{ "StatusVerifiedDate":"January 2012", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"May 2009" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"June 2010", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"June 2010", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"October 1, 2010", "StudyFirstSubmitQCDate":"January 23, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 24, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"January 23, 2012", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"January 24, 2012", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Amen Clinics, Inc.", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"The investigators primary objective is to acquire preliminary data on one-hundred former NFL veterans with at least one full year of professional service using brain SPECT imaging in order to assess the degree to which NFL football puts players at risk for traumatic brain injury (TBI). TBI severity shall be gauged via visual inspection by a clinician trained in neuroanatomy, and also by a statistical comparison of subjects' brains to an in-house proprietary database comprised of the brains of healthy subjects.\n\nThe investigators secondary objective is to acquire additional data on these players such that investigators may establish causative factors and risks associated with said TBI.\n\nThe investigators tertiary objective is to acquire data on subjects using various mental health metrics in order to determine the effects of TBI." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Traumatic Brain Injury" ] }, "KeywordList":{ "Keyword":[ "SPECT", "Imaging", "Football", "Traumatic brain injury", "Regional cerebral blood flow" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignInterventionModel":"Single Group Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"100", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Supplement intervention", "ArmGroupType":"Experimental", "ArmGroupDescription":"Dietary Supplement: Multivitamin, Omega 3 Supplement, Brain and Memory Formula", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Dietary Supplement: Multivitamin Supplement intervention" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Dietary Supplement", "InterventionName":"Multivitamin Supplement intervention", "InterventionDescription":"We recommend the following protocol:\n\n2 tablets of a high quality multivitamin BID\n2 capsules of omega 3 fish oil BID for a total of 3 grams daily\n3 capsules of a brain and memory formula BID which contains Acetyl-L-Carnitine (HCL) 1000 mg, Ginkgo Biloba Extract 120 mg, Alpha-Lipoic Acid (ALA) 300 mg, Huperzine A (Huperzia serrata)150 mcg, N-Acetyl-L-Cysteine (NAC) 600mg, Phosphatidyl Serine (soy) 100 mg, Vinpocetine 15mg\nWeight loss", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Supplement intervention" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Omega 3 Fatty Acid", "Acetyl-L-Carnitine (HCL)", "Ginkgo Biloba Extract", "Alpha-Lipoic Acid (ALA)", "Huperzine A (Huperzia serrata)", "N-Acetyl-L-Cysteine", "Phosphatidyl Serine", "Vinpocetine" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"A concentration SPECT scan will be given to assess the changes in regional cerebral blood flow to the brain in our study participants.", "PrimaryOutcomeDescription":"For the concentration study the subject will start the Conner's Continuous Performance Task, a 15-minute computer-administered test of attention, subsequent to the accommodation period. Three minutes into task performance 20 milliCuries of Tc-99m-hexamethylpropylene amine oxime will be injected through the catheter with attention to minimal disruption of the subject's attention task. The subject will proceed to completion of the attention task. The concentration scans will then be compared to a healthy brain subject normative database.", "PrimaryOutcomeTimeFrame":"The SPECT scan is one day imaging exam. A follow up scan will be performed following a 2-12 month supplement intervention." } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Quantitative electroencephalography (QEEG) will be used to assess the damage to neural networks in our study participants.", "SecondaryOutcomeDescription":"Subjects will undergo quantitative electroencephalography (QEEG) testing in both the eyes open and eyes closed condition to measure the electrical activity patterns of the brain. Brain maps will be generated and compared against a normative database.", "SecondaryOutcomeTimeFrame":"The QEEG testing is one day exam. A follow up test will be performed following a 2-12 month supplement intervention." } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nSubjects must be at least 18 years of age\nEach subject must have been on an active NFL roster for a minimum of one year\n\nExclusion Criteria:\n\nAny subjects who could not cease taking psychoactive medications (recreational or otherwise) for an appropriate washout period prior to scanning were excluded from the study", "HealthyVolunteers":"Accepts Healthy Volunteers", "Gender":"Male", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Daniel G Amen, MD", "OverallOfficialAffiliation":"Amen Clinics, Inc.", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Amen Clinics, Inc.", "LocationCity":"Newport Beach", "LocationState":"California", "LocationZip":"92660", "LocationCountry":"United States" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"21304145", "ReferenceType":"result", "ReferenceCitation":"Amen DG, Newberg A, Thatcher R, Jin Y, Wu J, Keator D, Willeumier K. Impact of playing American professional football on long-term brain function. J Neuropsychiatry Clin Neurosci. 2011 Winter;23(1):98-106. doi: 10.1176/appi.neuropsych.23.1.98." },{ "ReferencePMID":"21615001", "ReferenceType":"result", "ReferenceCitation":"Amen DG, Wu JC, Taylor D, Willeumier K. Reversing brain damage in former NFL players: implications for traumatic brain injury and substance abuse rehabilitation. J Psychoactive Drugs. 2011 Jan-Mar;43(1):1-5. doi: 10.1080/02791072.2011.566489." } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000008063", "InterventionMeshTerm":"Thioctic Acid" },{ "InterventionMeshId":"D000000108", "InterventionMeshTerm":"Acetylcarnitine" },{ "InterventionMeshId":"D000000111", "InterventionMeshTerm":"Acetylcysteine" },{ "InterventionMeshId":"C000013983", "InterventionMeshTerm":"Vinpocetine" },{ "InterventionMeshId":"C000050426", "InterventionMeshTerm":"Huperzine A" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000000975", "InterventionAncestorTerm":"Antioxidants" },{ "InterventionAncestorId":"D000045504", "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action" },{ "InterventionAncestorId":"D000020011", "InterventionAncestorTerm":"Protective Agents" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" },{ "InterventionAncestorId":"D000014803", "InterventionAncestorTerm":"Vitamin B Complex" },{ "InterventionAncestorId":"D000014815", "InterventionAncestorTerm":"Vitamins" },{ "InterventionAncestorId":"D000018977", "InterventionAncestorTerm":"Micronutrients" },{ "InterventionAncestorId":"D000078622", "InterventionAncestorTerm":"Nutrients" },{ "InterventionAncestorId":"D000006133", "InterventionAncestorTerm":"Growth Substances" },{ "InterventionAncestorId":"D000018697", "InterventionAncestorTerm":"Nootropic Agents" },{ "InterventionAncestorId":"D000002800", "InterventionAncestorTerm":"Cholinesterase Inhibitors" },{ "InterventionAncestorId":"D000004791", "InterventionAncestorTerm":"Enzyme Inhibitors" },{ "InterventionAncestorId":"D000018678", "InterventionAncestorTerm":"Cholinergic Agents" },{ "InterventionAncestorId":"D000018377", "InterventionAncestorTerm":"Neurotransmitter Agents" },{ 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"InterventionBrowseLeafId":"M12212", "InterventionBrowseLeafName":"Phosphodiesterase Inhibitors", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M15995", "InterventionBrowseLeafName":"Vasodilator Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"T372", "InterventionBrowseLeafName":"Carnitine", "InterventionBrowseLeafAsFound":"Carnitine", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"T415", "InterventionBrowseLeafName":"Omega 3 Fatty Acid", "InterventionBrowseLeafAsFound":"Omega-3 fatty acids", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"T167", "InterventionBrowseLeafName":"Ginkgo", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"T359", "InterventionBrowseLeafName":"Alpha-lipoic Acid", "InterventionBrowseLeafAsFound":"Alpha-lipoic acid", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"T4", "InterventionBrowseLeafName":"Cysteine", "InterventionBrowseLeafAsFound":"Cysteine", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"T18", "InterventionBrowseLeafName":"Serine", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"T446", "InterventionBrowseLeafName":"Folic Acid", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"T448", "InterventionBrowseLeafName":"Folate", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"T475", "InterventionBrowseLeafName":"Vitamin B9", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"Infe", "InterventionBrowseBranchName":"Anti-Infective Agents" },{ "InterventionBrowseBranchAbbrev":"Resp", "InterventionBrowseBranchName":"Respiratory System Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" },{ "InterventionBrowseBranchAbbrev":"Micro", "InterventionBrowseBranchName":"Micronutrients" },{ "InterventionBrowseBranchAbbrev":"NootAg", "InterventionBrowseBranchName":"Nootropic Agents" },{ "InterventionBrowseBranchAbbrev":"NeuroAg", "InterventionBrowseBranchName":"Neuroprotective Agents" },{ "InterventionBrowseBranchAbbrev":"VaDiAg", "InterventionBrowseBranchName":"Vasodilator Agents" },{ "InterventionBrowseBranchAbbrev":"Hemat", "InterventionBrowseBranchName":"Hematinics" },{ "InterventionBrowseBranchAbbrev":"Ot", "InterventionBrowseBranchName":"Other Dietary Supplements" },{ "InterventionBrowseBranchAbbrev":"HB", "InterventionBrowseBranchName":"Herbal and Botanical" },{ "InterventionBrowseBranchAbbrev":"AA", "InterventionBrowseBranchName":"Amino Acids" },{ "InterventionBrowseBranchAbbrev":"Vi", "InterventionBrowseBranchName":"Vitamins" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000001930", "ConditionMeshTerm":"Brain Injuries" },{ "ConditionMeshId":"D000070642", "ConditionMeshTerm":"Brain Injuries, Traumatic" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000001927", "ConditionAncestorTerm":"Brain Diseases" },{ "ConditionAncestorId":"D000002493", "ConditionAncestorTerm":"Central Nervous System Diseases" },{ "ConditionAncestorId":"D000009422", "ConditionAncestorTerm":"Nervous System Diseases" },{ "ConditionAncestorId":"D000006259", "ConditionAncestorTerm":"Craniocerebral Trauma" },{ "ConditionAncestorId":"D000020196", "ConditionAncestorTerm":"Trauma, Nervous System" },{ "ConditionAncestorId":"D000014947", "ConditionAncestorTerm":"Wounds and Injuries" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M3789", "ConditionBrowseLeafName":"Brain Injuries", "ConditionBrowseLeafAsFound":"Brain Injury", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M628", "ConditionBrowseLeafName":"Brain Injuries, Traumatic", "ConditionBrowseLeafAsFound":"Traumatic Brain Injury", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M3786", "ConditionBrowseLeafName":"Brain Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4325", "ConditionBrowseLeafName":"Central Nervous System Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M16268", "ConditionBrowseLeafName":"Wounds and Injuries", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M7932", "ConditionBrowseLeafName":"Craniocerebral Trauma", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M20607", "ConditionBrowseLeafName":"Trauma, Nervous System", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC10", "ConditionBrowseBranchName":"Nervous System Diseases" },{ "ConditionBrowseBranchAbbrev":"BC26", "ConditionBrowseBranchName":"Wounds and Injuries" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" } ] } } } } } }