Title
Hyperbaric Oxygen Therapy (HBOT) in Chronic Traumatic Brain Injury (TBI)/Post Concussion Syndrome (PCS) and TBI/Post-Traumatic Stress Disorder (PTSD)
HBOT in Chronic Traumatic Brain Injury/Post Concussion Syndrome and TBI/PTSD Pilot Trial
Phase
Phase 1Lead Sponsor
Louisiana State UniversityStudy Type
InterventionalStatus
Completed No Results PostedIntervention/Treatment
oxygen ...Study Participants
30This 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.
HBOT at 1.5 ATA/60 minutes twice/day, five days/week for 40 or 80 treatments
HBOT: 1.5 ATA/60 minutes twice/day, 5 days/week for 40 or 80 treatments
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, 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
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)
