Status:
RECRUITING
Cognitive and Vascular Functioning Following TBI
Lead Sponsor:
Walter Reed National Military Medical Center
Collaborating Sponsors:
Johns Hopkins University
Conditions:
Traumatic Brain Injury
Cognitive Decline
Eligibility:
All Genders
18-74 years
Brief Summary
This observational study will examine the association of chronic traumatic cerebrovascular injury and cardiovascular risk factors with TBI-related cognitive impairment and vascular dementia. Cerebrova...
Detailed Description
The investigators will enroll 300 Service Members (SMs) and Veterans who participated in the National Intrepid Center of Excellence (NICoE) intensive outpatient program or Defense and Veterans Brain I...
Eligibility Criteria
Inclusion
- Active duty uniformed SM or Veteran who is currently eligible for treatment at WRNMMC (i.e., Defense Enrollment Eligibility Reporting System (DEERS)-eligible).
- Ability to read, write, and speak English.
- Ability to provide informed consent.
- NICoE Intensive Outpatient Program (IOP) or NatHx Study comprehensive evaluation ≥3 years prior to current evaluation with valid neuropsychological test results.
- Consent to allow access to prior research data collected through the NICoE TBI Neuroimaging Core Project or NatHx Study and consent to allow access to at least 1 prior blood specimen previously collected through these studies or the DoD Serum Biorepository.
- Additional TBI Inclusion Criteria
- 1\. History of at least one mild, moderate, severe, or penetrating TBI \> 3 years prior to enrollment. TBI will be diagnosed if any one of the following criteria immediately after the injury is met and attributed to the brain injury, rather than environmental/psychological/other injury factors (DoD-VA criteria246):
- Loss of consciousness (LOC) or post-traumatic amnesia (PTA)
- Alteration of consciousness (AOC)
- Evidence of neurologic dysfunction
- TBI-related abnormality on structural neuroimaging (either CT or MRI). Additional Healthy Control Criteria
- History of military deployment.
- Low history of blast exposure (i.e., \<10 blasts) Additional Blast Control Criteria
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- History of significant blast exposure (i.e., exposure to ≥ 10 blasts)
Exclusion
- Disabling neurologic or psychological disorders such as autism, cerebral palsy, developmental disorder, stroke, brain tumor, multiple sclerosis, meningitis, encephalitis, brain abscess, vascular malformation, pre-injury epilepsy, schizophrenia, bipolar disorder, personality disorder
- Diabetes mellitus requiring drug treatment
- Hypertension requiring more than 1 antihypertensive drug to control BP
- History of myocardial infarction or other systemic vasculopathies
- Dementia diagnosis at initial NICoE/NatHx Study assessment
Key Trial Info
Start Date :
November 27 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06034509
Start Date
November 27 2023
End Date
May 1 2027
Last Update
September 26 2025
Active Locations (1)
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1
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889