What this study is
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
What's being tested
- No intervention. This is an observational study.
Intervention · OTHER
There are no interventions being tested in the Cognitive and Vascular Functioning Following TBI study.
Study details
- Sponsor
- Walter Reed National Military Medical Center
- Conditions
- Traumatic Brain Injury · Cognitive Decline · Vascular Dementia
- Enrolling
- 300 people
- Starts
- 2023-11-27
- Est. completion
- 2027-05
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 74 YearsSex ALLHealthy volunteers Not acceptedAll participants
You may qualify if
- 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
You may qualify if
- 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; History of significant blast exposure (i.e., exposure to ≥ 10 blasts)
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openWalter Reed National Military Medical Center
Bethesda, Maryland, United States
- Sara Lippa, PhD · Contact
Recruiting
Study team
Sponsor
Walter Reed National Military Medical Center
Study ID WRNMMC-2022-0409
Principal investigator
Sara M Lippa, PhD
Walter Reed National Military Medical Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.