About the Trial
The goal of this blinded, adaptive, randomized, placebo-controlled clinical trial is to investigate the use of hyperbaric oxygen as a therapy to treat mild to moderate traumatic brain injury in Veterans and active-duty service military.
Who is Eligible?
U.S. Service Members and Veterans, between 18 and 75 years of age
History of Traumatic Brain Injury (TBI).
Participants must have a minimum of 1 year post injury and a TBI classified as mild to moderate
Experiencing chronic symptoms of TBI
Able to tolerate the HBOT environment lying down for one hour
How it works
Each participant will undergo a total of 40 HBOT dives over a span of 12 weeks. Each dive session takes approximately 90-minutes (~75 minutes in the HBOT chamber).
The Study Process
Throughout the study, participants will be asked to:
- Complete questionnaires.
- Complete brain games.
- Give blood samples to test for markers of inflammation.
Participants may also choose to participate in further testing, which will include:
- Giving a stool sample before and after the 40 dives.
- Receiving electroencephalogram (EEG) and more brain games.
- Accepting and agreeing to wear a device that will monitor sleep patterns.
Study Logistics
Timing: Actively Enrolling.
Main Intervention: Active or inactive HBOT. Approximately 12 weeks of daily sessions.
Location:
University of South Florida,
Health Campus
13220 Laurel Drive
Tampa, FL 33612
Exploratory Sub-Studies Available
- EEG readings at the USF Health site pre and post study intervention with main contact ___.
- Microbiome analysis through at home stool sample collections pre and post study intervention.
- fMRI reads pre and post HBOT treatments at the USF Health site.
- Qualitative interviews conducted virtually and at the USF Health site.
- Sleep wearable device: worn throughout the study duration to passively measure biometric data.
Logistics
Directions and parking information for the USF Health HBOT and fMRI Center (box link)