Detection and Amelioration of Gamma Oscillation Abnormalities in Blast-Related Brain Injury (NCT03836976) | Clinical Trial Compass
CompletedNot Applicable
Detection and Amelioration of Gamma Oscillation Abnormalities in Blast-Related Brain Injury
United States5 participantsStarted 2019-12-02
Plain-language 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 consequences of blast exposure is distance from the blast, rather than the presence or absence of concussion symptoms. Exposure to blasts from a distance of \<10 m has been associated with significantly greater cognitive and neural problems than exposure to blasts from \>10 m. So far, the effects of blast-related brain injury on the brain are poorly understood, as to date the effects of blast exposure have received little research focus. The investigators propose to use oscillations in the gamma band (30-100 Hz) of the electroencephalogram (EEG; brain waves) to detect and remediate neural circuit dysfunction related to blast injury in Veterans. If successful, this project could lead to new approaches to detect and remediate the effects of blast exposure on Veterans and aid in their functional recovery.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial studied 'gamma oscillations' in the brain after blast-related mild traumatic brain injury — can you explain what that means and whether measuring my brain's gamma activity could tell us anything useful about my injury?
2Since this trial has already been completed, has any data or findings been published, and if so, do the results suggest anything relevant to how my mTBI should be evaluated or treated?
3The trial looked at both 'evoked' and 'spontaneous' gamma brain wave patterns — are either of these types of brain activity something that could or should be assessed in my own care?
4This study was focused specifically on blast-related brain injury, which often affects military veterans — does my own history and type of mTBI match the kind of patients who were studied, and does that affect how relevant the findings might be for me?
5Are there any current standard-of-care options for treating gamma oscillation abnormalities after mTBI, or is this still an area where research is ongoing and nothing proven is yet available to me??
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in evoked gamma power of conditioned vs. unconditioned tones
Timeframe: 0 minutes
2
Change in evoked gamma power of conditioned vs. unconditioned tones