Examining cognitive and vascular functioning after traumatic brain injury

Cognitive and Vascular Functioning Following TBI

This study is trying to see how brain injuries and heart health are connected to thinking problems in Service Members and Veterans.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 18 Years to 74 Years
• Sex: All
• Sponsor: Walter Reed National Military Medical Center (Federal)
• Locations: 1 site (Bethesda, Maryland)
• Trial ID: NCT06034509 on ClinicalTrials.gov

What this trial studies

This observational study investigates the relationship between chronic traumatic cerebrovascular injury and cardiovascular risk factors with cognitive impairment and vascular dementia in Service Members and Veterans. It will enroll 300 participants who have previously undergone evaluations related to traumatic brain injury and will utilize a variety of assessments, including neuropsychological testing, MRI imaging, and blood biomarker analysis. The study aims to understand how these factors contribute to cognitive decline following traumatic brain injury.

Who should consider this trial

Good fit: Ideal candidates are active duty Service Members or Veterans with a history of traumatic brain injury who are eligible for treatment at Walter Reed National Military Medical Center.

Not a fit: Patients without a history of traumatic brain injury or those who do not meet the eligibility criteria will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and management of cognitive decline and vascular dementia in individuals with a history of traumatic brain injury.

How similar studies have performed: Other studies have explored similar associations between traumatic brain injury and cognitive decline, indicating potential for meaningful insights, though this specific approach may be novel.

Eligibility criteria

Inclusion Criteria:

1. Active duty uniformed SM or Veteran who is currently eligible for treatment at WRNMMC (i.e., Defense Enrollment Eligibility Reporting System (DEERS)-eligible).
2. Ability to read, write, and speak English.
3. Ability to provide informed consent.
4. NICoE Intensive Outpatient Program (IOP) or NatHx Study comprehensive evaluation ≥3 years prior to current evaluation with valid neuropsychological test results.
5. 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):

1. Loss of consciousness (LOC) or post-traumatic amnesia (PTA)
2. Alteration of consciousness (AOC)
3. Evidence of neurologic dysfunction
4. TBI-related abnormality on structural neuroimaging (either CT or MRI). Additional Healthy Control Criteria

   1. History of military deployment.
   2. Low history of blast exposure (i.e., \<10 blasts) Additional Blast Control Criteria

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   1. History of significant blast exposure (i.e., exposure to ≥ 10 blasts)

Exclusion Criteria:

1. 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
2. Diabetes mellitus requiring drug treatment
3. Hypertension requiring more than 1 antihypertensive drug to control BP
4. History of myocardial infarction or other systemic vasculopathies
5. Dementia diagnosis at initial NICoE/NatHx Study assessment

Where this trial is running

Bethesda, Maryland

• Walter Reed National Military Medical Center — Bethesda, Maryland, United States (Recruiting)

Study contacts

• Principal investigator: Sara M Lippa, PhD — Walter Reed National Military Medical Center
• Study coordinator: Sara M Lippa, PhD

Conditions Traumatic Brain Injury; Cognitive Decline; Vascular Dementia; Blood Biomarkers; Cerebrovascular Reactivity; Military