Observational Study on Cognitive and Vascular Functioning After TBI
This observational study, called "Cognitive and Vascular Functioning Following TBI," is looking at how traumatic brain injury (TBI) might be connected to problems with thinking and memory (cognitive impairment) and a type of memory loss called vascular dementia. Researchers are studying 300 active duty service members and veterans who have had a TBI. They will look at blood markers (biomarkers) related to blood vessels, inflammation, and brain cell health, along with clinical information and brain scans. The goal is to understand how TBI and heart/blood vessel risk factors might lead to these cognitive issues. This study does not involve any new treatments; it's about observing and understanding these connections. The study is currently unclear on its recruitment status.
- Study design
- This is an observational study, meaning researchers will collect information without giving any new treatments. It plans to include 300 participants.
- What's involved
- Participants will undergo interviews, a neurological exam, neuropsychological testing, and various types of MRI brain scans. They will also have an additional blood draw.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcomes, including blood biomarkers and cognitive performance, will be measured at 3 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Cognitive and Vascular Functioning Following TBI
At a glance
Conditions
NCT06034509
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Walter Reed National Military Medical Center
Bethesda, Marylandno site contact published
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Sara M Lippa, PhD · PRINCIPAL_INVESTIGATOR · Walter Reed National Military Medical Center
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Panel of blood biomarkers3 years
A panel of blood biomarkers including vascular (e.g., vascular endothelial growth factor, von Willebrand Factor, cholesterol, lipoproteins, homocysteine, fibrinogen, hemoglobin A1C), inflammatory (e.g., high sensitivity c-reactive protein, Tumor Necrosis Factor-alpha, IL-6, IL-12p70, YKL-40), and neuronal degeneration (e.g., neurofilament light, Glial Fibrillary Acidic Protein, phosphorylated tau, Clusterin, brain-derived neurotrophic factor, beta amyloid proteins) will be compared between TBI groups. One-way ANOVAs will be run with TBI severity as the independent variable and each individual blood biomarker (measured in pg/mL) as the dependent variable. Spearman's rank order correlations will evaluate the relationship between blood biomarkers, number of TBIs, and TBI severity.
- Cognitive Performance- Overall Test Battery Mean3 years
Neurocognitive data will be corrected for age, gender, education, and race, as available. An overall test battery mean (OTBM) T-score will be calculated as the average of seven cognitive domain T-scores (attention/processing speed, working memory, executive functioning, learning/immediate memory, delayed memory, language, perceptual reasoning). Each biomarker will be correlated with the OTBM using Spearman's rank order correlations. Cognitive domain T-scores will also be evaluated to understand which are driving changes in the OTBM. All scores will be evaluated as T-scores (mean=50, SD=10, min=0, max=100), for which higher scores indicate higher cognitive performance. Multivariable logistic regression will be used to evaluate the relationship between TBI number, TBI severity, blood biomarkers and normal cognition vs. mild cognitive impairment (MCI).