Study of Hyperbaric Oxygen Therapy to Treat Mild to Moderate Traumatic Brain Injury in Veterans and Military Members

What this Trial Is About

This trial investigates hyperbaric oxygen therapy HBOT as a potential treatment for mild to moderate traumatic brain injury TBI in Veterans and active military members. Researchers aim to determine if HBOT reduces neurobehavioral symptoms and PTSD symptoms, and how many sessions are needed for improvement. Additional exploratory assessments will look at cognitive function, inflammation, microbiome, EEG, sleep, and brain imaging changes. Participants will be randomly assigned to receive either HBOT at 2.0 ATA with 100% oxygen or a placebo with normal air at 1.0 ATA in a specialized chamber. They will complete 40 treatment sessions over 12 weeks, each lasting about 76 minutes. Assessments occur at baseline, mid-treatment after 20 sessions, and post-treatment 2 weeks after the last session. Blood pressure, respiration, pulse, and glucose if diabetic will be monitored during treatments. Participants will undergo comprehensive baseline assessments including questionnaires, interviews, cognitive tasks, physical exams, and blood draws. During the study, they will complete regular self-report measures and interviews to evaluate symptoms and wellbeing. Follow-up visits continue 2 weeks post-treatment to assess changes and participant impressions. Blood samples and optional stool samples will be collected to analyze biomarkers. Participants randomized to placebo may receive HBOT after study completion. The study lasts several months including treatment and follow-up.

Hyperbaric Oxygen Treatment for Veterans With Traumatic Brain Injury