Contributions of mTBI to Neurodegeneration Due to Chronic Traumatic Encephalopathy (CTE) and Alzheimer's Disease (AD)
NCT ID: NCT04124029
Last Updated: 2025-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
800 participants
OBSERVATIONAL
2021-07-01
2026-06-30
Brief Summary
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Detailed Description
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This study will recruit patients with a history of mild-moderate traumatic brain injury, mild cognitive impairment, as well as healthy controls in order to better understand how single or repetitive mild Traumatic brain injuries may contribute to the development of dementia. It will be prospective in nature. Participants will be asked to complete a series of 3 study sessions. During the first study session, each subject will be asked to complete a neuropsychological assessment. If the subject's testing scores fall under the study criteria, they will also be asked to complete a computer task. In the second study session, the investigators will measure the subjects brain waves using an EEG while they complete a computer task. During the computer task, subjects will be asked to study a list of words and the investigators will test the subjects on their memory for those words. During the final study session, the investigators will ask subjects to complete (1) an MRI scan, (2) a standard blood draw procedure, and (3) a lumbar puncture procedure.
Clinical Implications: These studies will provide a better understanding of which individuals with Traumatic Brain Injury will develop dementia, and how many years in the future dementia may occur.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Younger mild Traumatic Brain Injury
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 20/30 or better in order to be included in the study.
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.
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.
No intervention will be used.
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 20/30 or better in order to be included in the study.
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.
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.
No intervention will be used.
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 20/30 or better in order to be included in the study.
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.
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.
No intervention will be used.
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.
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.
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.
No intervention will be used.
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.
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.
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.
No intervention will be used.
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.
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.
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.
No intervention will be used.
Interventions
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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.
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.
No intervention will be used.
Eligibility Criteria
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Inclusion Criteria
* Intact color vision
* Visual acuity of 20/30 (or better)
* Patients must pass effort measures on the TOMM
* Patients must have intact decision-making capacity
* Patients must have no contraindications to lumbar puncture including:
* Being on a blood thinner
* Aspirin or Plavix
* Have no space occupying lesion on magnetic resonance imaging (MRI)
* An International Normalized Ratio (INR) value \< 1.4 and platelet count \>50,000
* No epidural infection or overlying cellulitis over the lumbar spine
* PTSD will be accounted for as a potential confounder and its presence will be included as a covariate in all analyses
Mild TBI Subjects:
* Subjects will be recruited who have a physician diagnosis of 1 or more mTBI episodes without concomitant moderate or severe TBI diagnosis
* Mild TBI: Loss of consciousness greater than 30 minutes, posttraumatic amnesia greater than 24 hours, and/or altered mental status greater than 24 hours
Moderate TBI Subjects:
* Subjects will be recruited who have a physician diagnosis of 1 or more moderate TBI episodes
* Moderate TBI: loss of consciousness greater than 30 minutes, posttraumatic amnesia greater than 24 hours, and altered mental status greater than 24 hours
MCI Subjects:
* 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
* 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
* Subjects with MCI may or may not meet diagnostic criteria for MCI due to AD
* MCI subjects will be matched for their MoCA score with older TBI subjects
Healthy Controls:
* Cognitively normal control subjects, age-, education- and sex-matched with mild TBI subjects, but lacking and TBI history
* All subjects must be within 1 standard deviation of normal on all neuropsychologic testing in order to be enrolled
The 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
* Impaired decision-making ability
* Patients will be excluded if there are contraindications to MRI including:
* Implants
* Shrapnel
* Aneurysm clips
* Pacemaker
* Pregnancy
* Non-TBI subjects must not have had an TBI
* No contraindication to lumbar puncture or blood draw including:
* Being on a blood thinner
* Aspirin or Plavix
* No space occupying lesion on MRI that makes lumbar puncture contraindicated
Exclusion Criteria
* If the primary language is not English
* Are unable to understand the informed consent process
* Have a clinically significant problem with any of the following conditions:
* A history of TBI within 1 year of study
* Suicidal or homicidal ideation requiring intervention
* Schizophrenia
* Bipolar disorder
* Active alcohol or drug abuse
30 Years
90 Years
ALL
Yes
Sponsors
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VA Boston Healthcare System
FED
VA Office of Research and Development
FED
Responsible Party
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Principal Investigators
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Katherine Turk, MD
Role: PRINCIPAL_INVESTIGATOR
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Locations
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VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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I01-CX-19-008-CDA
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
NURD-011-19F
Identifier Type: -
Identifier Source: org_study_id
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