Improving brain function in veterans with blast-related injuries
Detection and Amelioration of Gamma Oscillation Abnormalities in Blast-Related Brain Injury
This study is testing if a special sound treatment can help improve brain function in veterans who have had injuries from blasts, looking at how the distance from the blast affects their recovery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT03836976 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate the cognitive and emotional problems faced by combat veterans exposed to blasts, focusing on the impact of the distance from the blast on brain function. Researchers will utilize electroencephalogram (EEG) measurements of gamma oscillations to detect and potentially remediate neural circuit dysfunction associated with mild traumatic brain injury (mTBI). The study will involve 50 veterans aged 18-65, half of whom experienced blasts from a close distance and the other half from a far distance, matched by age and gender. The intervention consists of auditory gamma sensory stimulation to enhance brain function and recovery.
Who should consider this trial
Good fit: Ideal candidates are veterans aged 18-65 who have experienced blast exposure, specifically those with varying distances from the blast.
Not a fit: Patients with a history of neurological illnesses, seizure disorders, or severe psychiatric conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to new methods for detecting and treating cognitive impairments in veterans affected by blast exposure.
How similar studies have performed: While the specific approach of using gamma oscillations in blast-related injuries is novel, related studies have shown promise in using EEG for cognitive enhancement in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: 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
Where this trial is running
Boston, Massachusetts
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Kevin M. Spencer, PhD — VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
- Study coordinator: Kevin M Spencer, PhD
- Email: Kevin.Spencer@va.gov
- Phone: (774) 826-1375
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.