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

Completed · Phase 2 · Has a placebo group

Conditions studied: Mild Traumatic Brain Injury, Post-Concussive Syndrome

In brief

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.

Key facts

Study ID

NCT01220713

Run by

Virginia Commonwealth University

People needed

60

Starts

2010-06-01

Expected to finish

2013-07-01

Last updated by the study team

2013-08-27

Who can join

Age: 19 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Post-Deployment status after having served in OIF/OEF
• Blast Event within past 3 years during OIF/OEF deployment [event defined as any of the following symptoms or experiences occurring during or shortly after the blast or explosion: dazed, confused, saw stars, headache, dizziness, irritability, memory gap (not remembering injury or injury period), hearing loss, abdominal pain, shortness of breath, struck by debris, knocked over or down, knocked into or against something, helmet damaged, evacuated]
• Diagnosis of MTBI within 3 years as confirmed by the TBI specialty team at the Richmond VAMC
• Presence of post-concussive symptoms from MTBI, confirmed by the VCU-CERSE team at the Richmond VAMC, for at least 3 months
• Medical clearance to undergo hyperbaric oxygen treatment
• Stable mental status for at least one month
• Stable psychotropic medication history for at least one month
• Ability to perform neuropsychologic testing battery
• Ability to tolerate neurophysiological and neuroimaging battery

You may not qualify if…

• Traumatic Brain Injury with a primary etiology other than blast
• Moderate or Severe TBI (moderate or severe brain injury defined as best Glasgow Coma Score in first 24 hours < 12, , brain bleeding or blood clot (i.e., abnormal brain CT scan), or none of first week after event can be remembered.)
• Past history of moderate or severe TBI
• Active diagnosis of Post-traumatic Stress Disorder
• Active diagnosis of Generalized Anxiety Disorder
• Active Psychosis
• Past history of Schizophrenia
• Pre-existing PCS
• Previous hyperbaric oxygen treatments
• Contraindications to HBO2, including any "air trapping" pulmonary problems, inability to equalize middle ear and sinuses, or patients who are claustrophobic and require anti-anxiety medication for the condition
• Active use of cancer medications
• Pregnancy

Where it is running

• Naval Medical Center Portsmouth — Portsmouth, Virginia, United States
• Hunter Holmes McGuire Veterans' Affairs Medical Center — Richmond, Virginia, United States
• Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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