Hyperbaric Oxygen Therapy in Chronic Stable Brain Injury

Completed · Phase 2

Conditions studied: Brain Injury, Sequelae, Stroke, Anoxia, Trauma

In brief

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.

Key facts

Study ID

NCT00830453

Run by

Intermountain Health Care, Inc.

People needed

63

Starts

2003-11-01

Expected to finish

2010-12-01

Last updated by the study team

2021-02-15

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 patients based on brain-injury induced psychiatric disorders, but will exclude patients with severe pre-injury psychiatric disorders.
• Patients taking lithium (due to the possibility of concomitant toxic side effects with hyperbaric oxygen therapy, specifically hyperexcitability).
• Degenerative Mental Disease (eg: Alzheimer's, multiple sclerosis, senile dementia, severe psychiatric disorder (schizophrenia, bi-polar disease, etc.).
• Presence of chronic debilitating disease (end-stage renal disease, end-stage liver disease, diabetes with sequelae).
• Heart failure patients with ejection fractions less than 50% or inability to lay supine.
• Patients with active malignancy, or prior treatment with cisplatin or bleomycin (there is some evidence that prior cisplatin and bleomycin therapy may place the patient at increased risk for serious oxidated stress with inhalation of high concentrations of oxygen).
• Evidence of current recreational drug use, either by history, or by comprehensive urine drug testing (due to confounds on outcome measure interpretation).
• Consumption of more than the equivalent of 12 beers/week habitually.
• Prior treatment with hyperbaric oxygen for chronic brain injury within the last year.
• Women of child-bearing potential

Where it is running

• LDS Hospital — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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