[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100372025":3},{"organization":4,"armGroups":7,"interventions":35,"overallOfficials":45,"centralContacts":50,"locations":57,"responsibleParty":75,"collaborators":77,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":10,"eligibilityCriteria":86,"healthyVolunteers":87,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":10,"studyType":94,"phases":10,"briefSummary":95,"conditions":96,"keywords":100,"overallStatus":59,"whyStopped":10,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"VA Office of Research and Development","FED",[8,15,19,23,27,31],{"label":9,"type":10,"description":11,"interventionNames":12},"Younger mild Traumatic Brain Injury",null,"mTBI subjects aged 30-59 yo will be recruited who have a physician diagnosis of 1 or more mTBI episodes without concomitant moderate or severe TBI diagnosis (loss of consciousness greater than 30 minutes, posttraumatic amnesia greater than 24 hours, or altered mental status greater than 24 hours). mTBI subjects must pass effort measures on the Test of Memory Malingering (TOMM) and have intact color vision and visual acuity of 20\u002F30 or better in order to be included in the study.",[13,14],"Device: No Intervention is used for this study but all subjects will be asked to complete EEG testing and an MRI scan.","Procedure: No intervention is used for this study but all subjects will be asked to complete a venous blood draw procedure and a lumbar puncture procedure.",{"label":16,"type":10,"description":17,"interventionNames":18},"Older mild Traumatic Brain Injury","mTBI subjects aged 60- 90 yo will be recruited who have a physician diagnosis of 1 or more mTBI episodes without concomitant moderate or severe TBI diagnosis (loss of consciousness greater than 30 minutes, posttraumatic amnesia greater than 24 hours, or altered mental status greater than 24 hours). mTBI subjects must pass effort measures on the TOMM and have intact color vision and visual acuity of 20\u002F30 or better in order to be included in the study.",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"moderate Traumatic Brain Injury","TBI control subjects, age-, education- and sex-matched with mTBI subjects (aged 30-90) will be recruited who have a physician diagnosis of 1 or more moderate TBI episodes (loss of consciousness greater than 30 minutes, posttraumatic amnesia greater than 24 hours, or altered mental status greater than 24 hours). Moderate TBI subjects must pass effort measures on the TOMM and have intact color vision and visual acuity of 20\u002F30 or better in order to be included in the study.",[13,14],{"label":24,"type":10,"description":25,"interventionNames":26},"Mild Cognitive Impairment (MCI)","MCI control subjects, age-, education- and sex-matched with older mTBI subjects (aged 60-90) will be recruited if they meet diagnostic criteria for MCI (without a history of TBI) based on the judgement of a behavioral neurologist following the 2011 MCI criteria. Specifically, subjects will test in the impaired range on one or more cognitive domains on neuropsychological testing and will not have impairments in function (i.e. will not meet diagnostic criteria for dementia). MCI subjects will be matched for their Montreal Cognitive Assessment (MoCA) score with older mTBI subjects. Of note, subjects with MCI may or may not meet diagnostic criteria for MCI due to AD. The intent of this control group is to recruit a broad range of MCI subjects without TBI as controls for subjects with cognitive impairment who have a history of mTBI.",[13,14],{"label":28,"type":10,"description":29,"interventionNames":30},"Younger Healthy Controls","Cognitively normal control subjects, age-, education- and sex-matched with younger mTBI subjects, but lacking and mTBI history. All subjects must be within 1 standard deviation of normal on all neuropsychologic testing in order to be enrolled.",[13,14],{"label":32,"type":10,"description":33,"interventionNames":34},"Older Healthy Controls","Cognitively normal control subjects, age-, education- and sex-matched with older mTBI subjects, but lacking and mTBI history. All subjects must be within 1 standard deviation of normal on all neuropsychologic testing in order to be enrolled.",[13,14],[36,41],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":10},"DEVICE","No Intervention is used for this study but all subjects will be asked to complete EEG testing and an MRI scan.","No intervention will be used.",[24,32,16,28,9,20],{"type":42,"name":43,"description":39,"armGroupLabels":44,"otherNames":10},"PROCEDURE","No intervention is used for this study but all subjects will be asked to complete a venous blood draw procedure and a lumbar puncture procedure.",[24,32,16,28,9,20],[46],{"name":47,"affiliation":48,"role":49},"Katherine Turk, MD","VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA","PRINCIPAL_INVESTIGATOR",[51],{"name":52,"role":53,"phone":54,"phoneExt":55,"email":56},"Kristina Morreale, BA","CONTACT","(857) 364-2139","4554","Kristina.Morreale@va.gov",[58],{"facility":48,"status":59,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"RECRUITING","Boston","Massachusetts","02130-4817","United States","US",{"type":66,"coordinates":67},"Point",[68,69],-71.05977,42.35843,{"lat":69,"lon":68},[72,74],{"name":52,"role":53,"phone":73,"phoneExt":55,"email":56},"857-364-2139",{"name":47,"role":49,"phone":10,"phoneExt":10,"email":10},{"type":76,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[78],{"name":79,"class":6},"VA Boston Healthcare System","100372025","contributions-of-mtbi-to-neurodegeneration-due-to-chronic-traumatic-encephalopathy-cte-and-alzheimers-disease-ad-100372025",false,"NCT04124029","Contributions of mTBI to Neurodegeneration Due to Chronic Traumatic Encephalopathy (CTE) and Alzheimer's Disease (AD)","Contributions of Mild Traumatic Brain Injury to Neurodegeneration Due to Chronic Traumatic Encephalopathy and Alzheimers Disease","Inclusion Criteria:\n\nAll Subjects:\n\n* Intact color vision\n* Visual acuity of 20\u002F30 (or better)\n* Patients must pass effort measures on the TOMM\n* Patients must have intact decision-making capacity\n* Patients must have no contraindications to lumbar puncture including:\n* Being on a blood thinner\n* Aspirin or Plavix\n* Have no space occupying lesion on magnetic resonance imaging (MRI)\n* An International Normalized Ratio (INR) value \\\u003C 1.4 and platelet count \\>50,000\n* No epidural infection or overlying cellulitis over the lumbar spine\n* PTSD will be accounted for as a potential confounder and its presence will be included as a covariate in all analyses\n\nMild TBI Subjects:\n\n* Subjects will be recruited who have a physician diagnosis of 1 or more mTBI episodes without concomitant moderate or severe TBI diagnosis\n* Mild TBI: Loss of consciousness greater than 30 minutes, posttraumatic amnesia greater than 24 hours, and\u002For altered mental status greater than 24 hours\n\nModerate TBI Subjects:\n\n* Subjects will be recruited who have a physician diagnosis of 1 or more moderate TBI episodes\n* Moderate TBI: loss of consciousness greater than 30 minutes, posttraumatic amnesia greater than 24 hours, and altered mental status greater than 24 hours\n\nMCI Subjects:\n\n* Subjects will be recruited that meet diagnostic criteria for MCI (without a history of TBI) based on the judgement of a behavioral neurologist following the 2011 MCI criteria\n* Specifically, subjects will test in the impaired range on one or more cognitive domains on neuropsychological testing and will not have impairments in function, i.e. will not meet diagnostic criteria for dementia\n* Subjects with MCI may or may not meet diagnostic criteria for MCI due to AD\n* MCI subjects will be matched for their MoCA score with older TBI subjects\n\nHealthy Controls:\n\n* Cognitively normal control subjects, age-, education- and sex-matched with mild TBI subjects, but lacking and TBI history\n* All subjects must be within 1 standard deviation of normal on all neuropsychologic testing in order to be enrolled\n\nThe investigators will recruit all subjects without regard to gender, race, ethnicity, socioeconomic status, or other factors to allow results of this research to yield the greatest generalizability\n\nExclusion Criteria:\n\nAll Subjects:\n\n* If the primary language is not English\n* Are unable to understand the informed consent process\n* Have a clinically significant problem with any of the following conditions:\n* A history of TBI within 1 year of study\n* Suicidal or homicidal ideation requiring intervention\n* Schizophrenia\n* Bipolar disorder\n* Active alcohol or drug abuse\n* Clinically significant neurological disease other than those stated in the inclusion criteria\n* Impaired decision-making ability\n* Patients will be excluded if there are contraindications to MRI including:\n* Implants\n* Shrapnel\n* Aneurysm clips\n* Pacemaker\n* Pregnancy\n* Non-TBI subjects must not have had an TBI\n* No contraindication to lumbar puncture or blood draw including:\n* Being on a blood thinner\n* Aspirin or Plavix\n* No space occupying lesion on MRI that makes lumbar puncture contraindicated",true,"ALL","30 Years","90 Years",{"count":92,"type":93},800,"ESTIMATED","OBSERVATIONAL","This is a research study that aims to examine whether Veterans with mild Traumatic Brain Injuries are at risk for dementia by studying their memory, brain wave activity, brain structure and proteins that can be elevated after brain injury and in dementia.",[97,98,99],"Mild Traumatic Brain Injury","Moderate Traumatic Brain Injury","Mild Cognitive Impairment",[97,98,101,102,103],"Alzheimer's Disease","Chronic Traumatic Encephalopathy","Neurodegeneration","2025-09-25",{"date":106,"type":107},"2025-09-26","ACTUAL",{"date":109,"type":107},"2021-07-01",{"date":111,"type":93},"2026-06-30",{"name":5,"class":6},1]