mTBI Mechanisms of Action of HBO2 for Persistent Post-Concussive Symptoms

PHASE2CompletedINTERVENTIONAL
Enrollment

71

Participants

Timeline

Start Date

September 11, 2012

Primary Completion Date

January 31, 2015

Study Completion Date

January 29, 2016

Conditions
Traumatic Brain Injury With Brief Loss of ConsciousnessPost-Concussion Syndrome
Interventions
DRUG

Hyperbaric oxygen (HBO2) at 1.5 atms

The Hyperbaric oxygen (HBO2) at 1.5 atms (active) group (hyperbaric oxygen-chamber compressed to 1.5 atm abs and breathing 100% oxygen). Each participant should complete 40 sessions over the course of 12 weeks, one session per day, five per week.

DRUG

Sham control 1.2 atms

The chamber will be compressed with air to 1.2 atm abs to simulate the active group. Participants will don a hood and breathe 21% oxygen (room air). Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs).

Trial Locations (5)

28542

Camp Lejeune, Jacksonville

80913

Outcomes Assessment Center, Evans Army Community Hospital, Colorado Springs

Evans Army Community Hospital / Hyperbaric Medicine Complex, Fort Carson

98431

TBI Program/HBO2 Research Program Madigan Healthcare system, Tacoma

98438

Joint Base Lewis-McChord, Fort Lewis

All Listed Sponsors
lead

U.S. Army Medical Research and Development Command

FED

NCT01611194 - mTBI Mechanisms of Action of HBO2 for Persistent Post-Concussive Symptoms | Biotech Hunter | Biotech Hunter