Recruiting

Observational Study

Sponsor:

Walter Reed National Military Medical Center

Code:

NCT06034509

Conditions

Traumatic Brain Injury

Cognitive Decline

Vascular Dementia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

No intervention. This is an observational study.

Study Details

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. Cerebrovascular, inflammatory, and neurodegenerative blood biomarkers as well as clinical and neuroimaging data

Conditions

Traumatic Brain Injury

Cognitive Decline

Vascular Dementia

Study ID

NCT06034509

Start date

Nov 27, 2023

Status verified date

Jul, 2025

Completion date

May, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

TBI Group

Participants in this group will have been identified as sustaining a traumatic brain injury (mild, moderate, severe, or penetrating).

High-blast exposed control group

Participants in this group will have no history of traumatic brain injury AND will have a lifetime history of greater than 10 blast exposures.

Low-blast exposed control group

Participants in this group will have no history of traumatic brain injury AND will have a lifetime history of less than 10 blast exposures.

Interventions

No intervention. This is an observational study.

There are no interventions being tested in the Cognitive and Vascular Functioning Following TBI study.

Primary outcome measure

  • Panel of blood biomarkers [ Time Frame: 3 years ]
  • Cognitive Performance- Overall Test Battery Mean [ Time Frame: 3 years ]

Central Contacts and Locations

Locations

Walter Reed National Military Medical Center

Recruiting

Bethesda, Maryland, United States, 20889

More Information

Sponsor

Walter Reed National Military Medical Center

Last update posted

Sep 26, 2025

Last verified

Jul, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Walter Reed National Military Medical Center on 2025-09-26.