Status:
COMPLETED
Hyperbaric Oxygen Therapy (HBOT) in Chronic Traumatic Brain Injury (TBI)/Post Concussion Syndrome (PCS) and TBI/Post-Traumatic Stress Disorder (PTSD)
Lead Sponsor:
Paul G. Harch, M.D.
Collaborating Sponsors:
Semper Fi Fund
Marine Corps-Law Enforcement Foundation
Conditions:
TBI (Traumatic Brain Injury)
Post Concussion Syndrome
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This is a pilot trial to see if one or two 40 treatment courses of low pressure hyperbaric oxygen therapy can improve cognition and brain imaging in subjects with either chronic mild-moderate traumati...
Eligibility Criteria
Inclusion
- Adults, 18-65 years old
- One or more mild-moderate TBI's characterized by loss of consciousness due to blast injury that is a minimum of one year old and occurred after 9/11/2001
- Absence of acute cardiac arrest or hemorrhagic shock at time of TBI.
- Absence of intracranial neurosurgery post-TBI
- Disability Rating Scale of 0-3
- Negative Michigan Alcohol Screening Test (MAST)
- Negative Drug Abuse Screening Test (DAST)
- Negative urine toxicology screen for drugs of abuse
- Negative pregnancy test in females
- Otherwise good health
- Less than 90% on the Percent Back to Normal Rating Scale
Exclusion
- Pulmonary disease that precludes HBOT
- Unstable medical conditions that are contraindicated in HBOT
- Severe confinement anxiety
- Pregnancy
- Other pre-TBI neurological diagnoses
- Pre or post TBI history of substance abuse
- Pre or post TBI history of alcoholism.
- Participation in another experimental trial with active intervention.
- High probability of inability to complete the experimental protocol.
- Previous HBOT
- History of hospitalization for past TBI, stroke, nonfebrile seizures, or any seizure history other than seizure at the time of TBI
- Past or current history of mental retardation (baseline FSIQ \< 71.
- Pre/post-TBI history of systemic illness with impact on CNS (P.I.'s decision)
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00760734
Start Date
September 1 2008
End Date
June 1 2011
Last Update
April 18 2017
Active Locations (1)
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1
LSU Health Sciences Center
New Orleans, Louisiana, United States, 70112