NCT06034509 Cognitive and Vascular Functioning Following TBI
| NCT ID | NCT06034509 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Walter Reed National Military Medical Center |
| Condition | Traumatic Brain Injury |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2023-11-27 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2023-11-27 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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 <!-- --> 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
Contact & Investigator
Sara M Lippa, PhD
PRINCIPAL INVESTIGATOR
Walter Reed National Military Medical Center
Frequently Asked Questions
Who can join the NCT06034509 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 74 Years, studying Traumatic Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06034509 currently recruiting?
Yes, NCT06034509 is actively recruiting participants. Contact the research team at sara.m.lippa.civ@health.mil for enrollment information.
Where is the NCT06034509 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT06034509 clinical trial?
NCT06034509 is sponsored by Walter Reed National Military Medical Center. The principal investigator is Sara M Lippa, PhD at Walter Reed National Military Medical Center. The trial plans to enroll 300 participants.