Actively Recruiting
Contributions of Mild Traumatic Brain Injury to Neurodegeneration Due to Chronic Traumatic Encephalopathy and Alzheimer's Disease
Led by VA Office of Research and Development · Updated on 2025-09-26
800
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
V
VA Office of Research and Development
Lead Sponsor
V
VA Boston Healthcare System
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying whether Veterans who have experienced mild Traumatic Brain Injuries (mTBI) are at increased risk for developing dementia. The study aims to understand the connections between mTBI, brain changes, and dementia by examining memory, brain wave activity, brain structure, and proteins linked to brain injury and dementia. Participants include those with mild to moderate traumatic brain injuries, mild cognitive impairment (MCI), and healthy controls to explore how brain injuries might contribute to dementia over time. Participants will take part in three separate study sessions. The first involves neuropsychological testing and, if certain criteria are met, a computer memory task. In the second session, brain wave activity will be measured using EEG while participants perform a memory test involving word lists. The final session includes an MRI scan, a blood draw, and a lumbar puncture to collect cerebrospinal fluid. No active treatments are given; this is an observational study evaluating these assessments. Throughout the study, researchers will track cognitive tests, EEG signals, brain volume changes on MRI, and protein markers in cerebrospinal fluid over five years. These measures aim to detect early signs of neurodegeneration related to Alzheimer's disease and Chronic Traumatic Encephalopathy. The study also monitors participants' ability to complete testing and ensures safety during procedures, with participation lasting up to five years.
CONDITIONS
Brief Title
Contributions of mTBI to Neurodegeneration Due to Chronic Traumatic Encephalopathy (CTE) and Alzheimer's Disease (AD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Intact color vision
- Visual acuity of 20/30 or better
- Pass effort measures on the Test of Memory Malingering (TOMM)
- Intact decision-making capacity
- No contraindications to lumbar puncture, including not being on blood thinners like aspirin or Plavix
- No space occupying lesion on MRI
- International Normalized Ratio (INR) value less than 1.4 and platelet count greater than 50,000
- No epidural infection or cellulitis over lumbar spine
- Physician diagnosis of one or more mild or moderate traumatic brain injury episodes (depending on group)
- For mild cognitive impairment (MCI) group: Meet 2011 MCI diagnostic criteria without history of TBI
- Cognitively normal controls must be within 1 standard deviation of normal on neuropsychological tests
- PTSD status considered in analysis
- No restrictions on gender, race, ethnicity, or socioeconomic status
You will not qualify if you...
- Primary language not English
- Unable to understand informed consent
- History of traumatic brain injury within 1 year
- Suicidal or homicidal ideation requiring intervention
- Diagnosis of schizophrenia or bipolar disorder
- Active alcohol or drug abuse
- Significant neurological disease other than those specified
- Impaired decision-making ability
- Contraindications to MRI including implants, shrapnel, aneurysm clips, pacemaker, or pregnancy
- Non-TBI subjects must have no history of traumatic brain injury
- Contraindications to lumbar puncture or blood draw such as being on blood thinners or aspirin
- Space occupying lesion on MRI making lumbar puncture unsafe
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 day
Participants complete neuropsychological assessments and computer tasks to evaluate cognitive function and memory.
1 visit (in-person)
Duration - Up to 1 day
Participants undergo EEG testing during computer tasks to assess brain wave activity related to memory function.
1 visit (in-person)
Duration - Up to 1 day
Participants complete an MRI scan, a blood draw, and a lumbar puncture to assess brain structure and protein markers.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States, 02130-4817
Actively Recruiting
Research Team
K
Kristina Morreale, BA
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
6
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