HBOT in Chronic Traumatic Brain Injury/Post Concussion Syndrome and TBI/PTSD Pilot Trial
Overview
- Phase
- Phase 1
- Intervention
- Low pressure hyperbaric oxygen therapy
- Conditions
- TBI (Traumatic Brain Injury)
- Sponsor
- Paul G. Harch, M.D.
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Psychometric testing
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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 traumatic brain injury (TBI), also known as post-concussion syndrome (PCS) or chronic PCS with post-traumatic stress disorder (PTSD) secondary to blast injury.
Investigators
Paul G. Harch, M.D.
Clinical Professor of Medicine
Louisiana State University Health Sciences Center in New Orleans
Eligibility 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
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
Arms & Interventions
Hyperbaric oxygen therapy-TBI/PCS
Intervention: Low pressure hyperbaric oxygen therapy, 40 or 80 twice daily, 5d/week, HBOTs at 1.5 ATA/60 minutes each. One month no treatment period between the 40th and 41st HBOT
Intervention: Low pressure hyperbaric oxygen therapy
Hyperbaric Oxygen Therapy-PCS/PTSD
Intervention: Low pressure hyperbaric oxygen therapy, 40 or 80 twice daily, 5d/week, HBOTs at 1.5 ATA/60 minutes each. One month no treatment period between the 40th and 41st HBOT
Intervention: Low pressure hyperbaric oxygen therapy
Outcomes
Primary Outcomes
Psychometric testing
Time Frame: 30 days
Secondary Outcomes
- Quality of life measurements(30 days)
- Return to school or work(6 months)
- SPECT brain imaging(30 days)