Hyperbaric Oxygen Therapy (HBO2T) for Post-Concussive Symptoms (PSC) After Mild Traumatic Brain Injury (mTBI)
Condition: Mild Traumatic Brain Injury; Post-Concussive Syndrome
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Post-Concussion Syndrome; Wounds and Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this research is to serve as a demonstration project to determine the
      tolerability of individuals with persistent post-concussive symptoms from combat-related mild
      TBI (traumatic brain injury), identify dose-finding for HBO2 (Hyperbaric Oxygen) therapy, and
      determine the efficacy of HBO2 therapy.
    

Detailed 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.
    

Intervention name(s): Hyperbaric Oxygen Therapy; Hyperbaric Oxygen Therapy; Hyperbaric Oxygen Therapy
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): 1.5 atm abs oxygen equivalent of 75% oxygen (balance 25% nitrogen), 40 treatments of 60 minutes each during a time period of up to ten weeks.; 2.0 atm abs oxygen equivalent of 100% oxygen (no nitrogen), 40 treatments of 60 minutes each during a time period of up to ten weeks.; sham--air equivalent of 10.5% oxygen (balance 89.5% nitrogen), 40 treatments of 60 minutes each during a time period of up to ten weeks.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Traumatic Brain Injury; Veterans; Hyperbaric Oxygen Treatment; OEF/OIF; Post-Concussive Symptoms; Blast Exposure