Hyperbaric Oxygen Therapy (HBO2T) for Post-Concussive Symptoms (PSC) After Mild Traumatic Brain Injury (mTBI): A Randomized, Double-Blinded, Sham Controlled, Variable Dose, Prospective Trial
Description:
Persistent post-concussive symptoms from mild traumatic brain injury are a severe issue
facing the readiness, retention and quality of life of Department of Defense(DoD) service
members and Veterans. The inadequacy of established treatment regimens and evidence-based
science in post-concussive symptoms (PCS)/MTBI is forcing a closer look at non-conventional
treatments of this condition. Hyperbaric oxygen (HBO2) is a potent intervention with
demonstrated efficacy in dive-related injuries, soft tissue healing, and carbon monoxide
poisoning.
This study is prospective, randomized, double-blinded and controlled. A total of 60 subjects
will be randomly assigned to one of three treatment arms of the study: 20 subjects into the
1.5 atm abs oxygen equivalent HBO2 treatment, 20 subjects into the 2.0 atm abs oxygen
equivalent HBO2 treatment and 20 subjects into the sham treatment (a placebo exposure
equivalent to breathing atmospheric air). The protocol utilizes a pre- and post-treatment
comprehensive performance battery that will allow for meaningful clinical outcomes and a
broad understanding of the effects of the treatment. This project represents a collaboration
between the Department of Defense (DoD), the Richmond Veterans Administration Medical Center
(VAMC) and Virginia Commonwealth University. Service members will be recruited from military
bases/treatment facilities (MTF), receive hyperbaric oxygen at existing DoD hyperbaric
chambers and be evaluated by the established Virginia Commonwealth University-Center for
Rehabilitation Sciences and Engineering (CERSE), a collaborative research center co-located
at the Richmond VAMC and VCU.
Condition:
Mild Traumatic Brain Injury
Treatment:
Hyperbaric Oxygen Therapy
Start Date:
June 2010
Sponsor:
Virginia Commonwealth University
For More Information:
https://clinicaltrials.gov/show/NCT01220713