Skip to main content
Clinical Trials/NCT04124029
NCT04124029
Recruiting
Not Applicable

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

VA Office of Research and Development1 site in 1 country800 target enrollmentJuly 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mild Traumatic Brain Injury
Sponsor
VA Office of Research and Development
Enrollment
800
Locations
1
Primary Endpoint
To better understand the contribution of mild Traumatic Brain Injury (mTBI) to neurodegeneration with the intent of detecting early behavioral, physiologic, anatomic, and protein evidence of neurodegeneration due to AD and CTE
Status
Recruiting
Last Updated
7 months ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
July 1, 2021
End Date
June 30, 2026
Last Updated
7 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • All Subjects:
  • Intact color vision
  • Visual acuity of 20/30 (or better)
  • Patients must pass effort measures on the TOMM
  • Patients must have intact decision-making capacity
  • Patients must have no contraindications to lumbar puncture including:
  • Being on a blood thinner
  • Aspirin or Plavix
  • Have no space occupying lesion on magnetic resonance imaging (MRI)
  • An International Normalized Ratio (INR) value \< 1.4 and platelet count \>50,000

Exclusion Criteria

  • All Subjects:
  • If the primary language is not English
  • Are unable to understand the informed consent process
  • Have a clinically significant problem with any of the following conditions:
  • A history of TBI within 1 year of study
  • Suicidal or homicidal ideation requiring intervention
  • Schizophrenia
  • Bipolar disorder
  • Active alcohol or drug abuse
  • Clinically significant neurological disease other than those stated in the inclusion criteria

Outcomes

Primary Outcomes

To better understand the contribution of mild Traumatic Brain Injury (mTBI) to neurodegeneration with the intent of detecting early behavioral, physiologic, anatomic, and protein evidence of neurodegeneration due to AD and CTE

Time Frame: 5 years

The work proposed will allow exploration of the relationships between behavioral, event-related potential (ERP), MRI, and cerebrospinal fluid (CSF) measures at a variety of points along the disease continuum and will allow for future longitudinal studies in this cohort

Secondary Outcomes

  • Cortical, quantitative MRI volume measurements(5 years)
  • CSF Proteinopathy(5 years)
  • Recognition Memory(5 Years)
  • EEG peak amplitude and latency(5 years)

Study Sites (1)

Loading locations...

Similar Trials