Hyperbaric Oxygen Therapy (HBO2T) for Post-Concussive Symptoms (PSC) After Mild Traumatic Brain Injury (mTBI)

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.

Conditions

• Mild Traumatic Brain Injury
• Post-Concussive Syndrome

Interventions

PROCEDURE

Hyperbaric Oxygen Therapy

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.

PROCEDURE

Hyperbaric Oxygen Therapy

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.

PROCEDURE

Hyperbaric Oxygen Therapy

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.

Sponsors & Collaborators

• United States Naval Medical Center, Portsmouth

  collaborator FED

• Hunter Holmes Mcguire Veteran Affairs Medical Center

  collaborator FED

• Virginia Commonwealth University

  lead OTHER

Principal Investigators

• David X Cifu, MD · Virginia Commonwealth University

• Brett Hart, MD · Naval Operational Medicine Institute

• Michelle Nichols, MSN, RN · McGuire Veterans' Affairs Medical Center

• Justin O Alicea · Virginia Commonwealth University

• Steven L West, PhD · Virginia Commonwealth University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

FACTORIAL

Eligibility

Min Age

19 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-06-30

Primary Completion

2013-07-31

Completion

2013-07-31

Countries

• United States

Study Locations