Status:
RECRUITING
Detection and Amelioration of Gamma Oscillation Abnormalities in Blast-Related Brain Injury
Lead Sponsor:
VA Office of Research and Development
Conditions:
mTBI
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Combat Veterans of post-9/11 conflicts have experienced serious cognitive and emotional problems resulting from exposure to blasts. Recent work suggests that a critical factor influencing the conseque...
Detailed Description
Veterans of recent conflicts have experienced serious cognitive and emotional problems resulting from exposure to blasts. Recent work suggests that a critical factor in the sequelae of blast exposure ...
Eligibility Criteria
Inclusion
- Research participants will be 50 veterans
- Ages 18-65 years
- Have experienced blast exposure
- Recruited from the VA Translational Research Center for TBI and Stress Disorders (TRACTS) at the VA Boston Healthcare System (VABHS)
- Half of the participants will have experienced blast exposure from a Close distance (\<10 m)
- Half of the participants will have experienced blast exposure from a Far distance (\>10 m)
- These groups will be matched on age and female/male ratio
Exclusion
- Initial exclusion criteria for TRACTS are:
- History of neurological illness
- Huntington's
- Parkinson's
- dementia, etc
- History of seizure disorders unrelated to head injury
- Current diagnosis of schizophrenia, bipolar, or other psychotic disorder
- Self-reported severe depression or anxiety requiring hospitalization overnight, or current active homicidal and/or suicidal ideation with intent requiring crisis intervention
- Cognitive disorder due to general medical condition other than TBI
- Unstable psychological diagnosis (suspected psychotic or personality disorder) that would interfere with accurate data collection, determined by consensus of at least three doctoral-level psychologists.
- Additional exclusion criteria for participants in the present project will be:
- Current alcohol or drug dependence, or abuse within the last 6 months (DSM-IV criteria)
- Hearing impairments as assessed by audiometry
Key Trial Info
Start Date :
December 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03836976
Start Date
December 2 2019
End Date
June 30 2028
Last Update
April 18 2025
Active Locations (1)
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1
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States, 02130-4817