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Pilot Study of Hyperbaric Oxygen Therapy (HBOT) in Chronic Traumatic Brain Injury (TBI)/Post Concussion Syndrome (PCS) and TBI/Post-Traumatic Stress Disorder (PTSD) - NCT00760734-70112(Clinical Trial 243408)



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City:  New Orleans
State:  
LA
Zip Code: 70112
Conditions: TBI (Traumatic Brain Injury) - Post Concussion Syndrome - Post Traumatic Stress Disorder - Chronic Post Traumatic Stress Disorder
Purpose: 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 traumatic brain injury (TBI), also known as post-concussion syndrome (PCS) or chronic PCS with post-traumatic stress disorder (PTSD) secondary to blast injury.
Study summary:
Criteria: Inclusion Criteria: - Adults, 18-45 years old - One or more mild-moderate TBI's characterized by loss of consciousness due to blast injury that is a minimum of one and maximum of four years old - 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 Addiction Severity Index (Severity score of less than 2) - 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 Criteria: - 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)
Study is available at: LSU Health Sciences Center
New Orleans, LA 70112
United States

Primary Contact:
Paul G Harch, M.D.
Email: paulharchmd@aol.com
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 22, 2011
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