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Understanding Traumatic Brain Injury and Dementia Risk

This research study is looking at how mild to moderate traumatic brain injuries (TBI) might contribute to brain diseases like Alzheimer's Disease (AD) and Chronic Traumatic Encephalopathy (CTE), which can cause memory problems. The study aims to find early signs of these conditions in Veterans. You would undergo tests like an EEG (measuring brain waves), an MRI (imaging your brain structure), blood draws, and a lumbar puncture (spinal tap to collect fluid). Researchers will be looking for changes in your behavior, body functions, brain structure, and specific proteins. This study is for people aged 30 to 90, including those with a history of TBI or mild cognitive impairment. The goal is to understand what success looks like over 5 years. The current recruitment status is unclear.

Study design
This is an observational study planning to enroll 800 participants. It will compare Veterans with a history of TBI, those with mild cognitive impairment, and healthy individuals.
What's involved
You would complete three study sessions. These include memory tests, a computer task while your brain waves are measured, an MRI scan, a blood draw, and a lumbar puncture.
Compensation
Not stated in the trial record.
Follow-up
The primary goal is to detect evidence of neurodegeneration over 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04124029

Contributions of mTBI to Neurodegeneration Due to Chronic Traumatic Encephalopathy (CTE) and Alzheimer's Disease (AD)

Recruiting
Not specifiedAges 30–90Observational
VA Office of Research and Development
~800 participants
Updated 2025-09-26 on ClinicalTrials.gov
What's tested:No Intervention is used for this study but all subjects will be asked to complete EEG testing and an MRI scan.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.

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To better understand the contribution of mild Traumatic Brain Injury (mTBI) to neurodegeneration with the intent of detecting early behavioral, physiologic, anatomic, and protein evidence of neurodegeneration due to AD and CTE
Measured over 5 years

Conditions

Mild Traumatic Brain Injury
Moderate Traumatic Brain Injury
Mild Cognitive Impairment

Explore related trials

Alzheimer's DiseaseChronic traumatic encephalopathyConcussionMild cognitive disorderNeurodegeneration

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Katherine Turk, MD · PRINCIPAL_INVESTIGATOR · VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Who to contact

Kristina Morreale, BA
[email protected]
(857) 364-2139 · ext. 4554
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
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
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
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
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
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

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

What this trial measures

  • To better understand the contribution of mild Traumatic Brain Injury (mTBI) to neurodegeneration with the intent of detecting early behavioral, physiologic, anatomic, and protein evidence of neurodegeneration due to AD and CTE5 years

    The work proposed will allow exploration of the relationships between behavioral, event-related potential (ERP), MRI, and cerebrospinal fluid (CSF) measures at a variety of points along the disease continuum and will allow for future longitudinal studies in this cohort