Hyperbaric Oxygen Therapy (HBOT) in Chronic Traumatic Brain Injury (TBI)/Post Concussion Syndrome (PCS) and TBI/Post-Traumatic Stress Disorder (PTSD)
United States30 participantsStarted 2008-09
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)