Status:
COMPLETED
Hyperbaric Oxygen Therapy (HBO2T) for Post-Concussive Symptoms (PSC) After Mild Traumatic Brain Injury (mTBI)
Lead Sponsor:
Virginia Commonwealth University
Collaborating Sponsors:
United States Naval Medical Center, Portsmouth
Hunter Holmes Mcguire Veteran Affairs Medical Center
Conditions:
Mild Traumatic Brain Injury
Post-Concussive Syndrome
Eligibility:
All Genders
19-60 years
Phase:
PHASE2
Brief 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 inj...
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. ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01220713
Start Date
June 1 2010
End Date
July 1 2013
Last Update
August 27 2013
Active Locations (3)
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1
Naval Medical Center Portsmouth
Portsmouth, Virginia, United States
2
Hunter Holmes McGuire Veterans' Affairs Medical Center
Richmond, Virginia, United States
3
Virginia Commonwealth University
Richmond, Virginia, United States