Hyperbaric Oxygen Therapy (HBOT) in Chronic Traumatic Brain Injury (TBI)/Post Concussion Syndrome (PCS) and TBI/Post-Traumatic Stress Disorder (PTSD)

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

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 traumatic brain injury (TBI), also known as post-concussion syndrome (PCS) or chronic PCS with post-traumatic stress disorder (PTSD) secondary to blast injury.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Paul G. Harch, M.D.
• Collaborators: Coalition to Support America's Heroes; Marine Corps Law Enforcement Foundation; Marine Corps-Law Enforcement Foundation; Semper Fi Fund; Thirty-eight other contributors

Criteria

Inclusion Criteria:

• 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 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)