NCT04124029

Contributions of mTBI to Neurodegeneration Due to Chronic Traumatic Encephalopathy (CTE) and Alzheimer's Disease (AD)

Contributions of Mild Traumatic Brain Injury to Neurodegeneration Due to Chronic Traumatic Encephalopathy and Alzheimers Disease

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 800 (estimated)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 30 Years – 90 Years
• Healthy volunteers: Accepted

Summary

This is a research study that aims to examine whether Veterans with mild Traumatic Brain Injuries are at risk for dementia by studying their memory, brain wave activity, brain structure and proteins that can be elevated after brain injury and in dementia.

Detailed description

The specific aim of this project is to examine whether Veterans with mild Traumatic Brain Injuries are at risk for dementia by studying their memory, brain wave activity, brain structure and proteins that can be elevated after brain injury and in dementia. This study will recruit patients with a history of mild-moderate traumatic brain injury, mild cognitive impairment, as well as healthy controls in order to better understand how single or repetitive mild Traumatic brain injuries may contribute to the development of dementia. It will be prospective in nature. Participants will be asked to complete a series of 3 study sessions. During the first study session, each subject will be asked to complete a neuropsychological assessment. If the subject's testing scores fall under the study criteria, they will also be asked to complete a computer task. In the second study session, the investigators will measure the subjects brain waves using an EEG while they complete a computer task. During the computer task, subjects will be asked to study a list of words and the investigators will test the subjects on their memory for those words. During the final study session, the investigators will ask subjects to complete (1) an MRI scan, (2) a standard blood draw procedure, and (3) a lumbar puncture procedure. Clinical Implications: These studies will provide a better understanding of which individuals with Traumatic Brain Injury will develop dementia, and how many years in the future dementia may occur.

Conditions

• Mild Traumatic Brain Injury
• Moderate Traumatic Brain Injury
• Mild Cognitive Impairment

Interventions

Type	Name	Description
DEVICE	No Intervention is used for this study but all subjects will be asked to complete EEG testing and an MRI scan.	No intervention will be used.
PROCEDURE	No intervention is used for this study but all subjects will be asked to complete a venous blood draw procedure and a lumbar puncture procedure.	No intervention will be used.

Timeline

• Start date: 2021-07-01
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2019-10-11
• Last updated: 2025-09-26

Locations

1 site across 1 country: United States