Hyperbaric Oxygen Therapy in Chronic Stable Brain Injury
United States63 participantsStarted 2003-11
Plain-language summary
The purpose of this study is to discover the feasibility of conducting clinical research in individuals with chronic sequelae following brain injury who are given hyperbaric oxygen. This study will also look at the outcome of individuals with a chronic stable brain injury due to trauma, anoxia (lack of oxygen to the brain), or stroke, who are given hyperbaric oxygen. Outcome measures testing cognitive (memory, etc.) and functional (balance, strength, etc.) measures will be performed before the hyperbaric sessions, immediately following them, and 6 months later. The subject will receive 60 hyperbaric sessions, 60 minutes in the chamber, to a pressure of 1.5 ATA, once daily, Monday through Friday.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* Subject has had a brain injury at least 12 months prior to study enrollment.
* Subject is at least 18 years old.
* Etiology of brain injury: Stroke, anoxia, and trauma
* Must be able to equalize ears, or have tympanostomy tubes
* Willingness to complete outcome measures and complies with the research protocols.
* Commitment to pay the hospital for hyperbaric oxygen.
Exclusion Criteria:
* Glasgow Coma Scores less than 13 at the time of hyperbaric oxygen evaluation.
* Poorly controlled seizures(ie:\>1 generalized seizure in past 3 months despite appropriate anticonvulsant therapy). Pharmacologically-controlled seizures or focal seizures are not an exclusion to participate.
* Inability to participate in outcome assessments (eg: blindness, quadraplegia)
* Claustrophobia (unwillingness or inability to enter the hyperbaric chamber).
* Inability to equalize ears. The patient could elect to have bilateral tympanostomy tubes.
* Inability to protect airway, and or requiring frequent suctioning.
* Patients requiring tracheostomy will be ineligible due to limitations in autoinflation of the middle ear space and difficulty to perform airway suctioning in the single-person chamber.
* Pregnancy (beta HCG will be assayed in women who could be pregnant prior to enrollment).
* Severe psychiatric disorders such as schizophrenia and bi-polar disease. We appreciate that psychiatric problems such as depression and anxiety may follow brain injuries so we would not exclude p…
What they're measuring
1
With this feasibility trial we wish to determine if we can recruit suitable subjects and if they will be able to comply with the protocol and tolerate 60 hyperbaric oxygen sessions.
Timeframe: Immediately following completion of final hyperbaric oxygen session