Functional and Anatomical Magnetic Resonance Imaging (MRI) of Chronic Brain Injury and Hyperbaric Oxygen (HBO2) Study Subjects

Completed

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

In brief

The purpose of this study is to evaluate Brain MRI (Magnetic Resonance Imaging), and Brain CT (Computed Tomography) Angiogram data in subjects who participate in the "Hyperbaric Oxygen for Chronic Stable Brain Injury" (HYBOBI) study. Including information from MRI and CT studies provide information about whether hyperbaric oxygen improves brain function in subjects who have had a brain injury. Subjects will complete MR and CT scans twice during the study. The first MR and CT will be performed prior to the first hyperbaric session of the HYBOBI study, and the second will be performed within two weeks following the last hyperbaric session.

Key facts

Study ID

NCT01126515

Run by

Intermountain Health Care, Inc.

People needed

17

Starts

2007-07-01

Expected to finish

2010-06-01

Last updated by the study team

2020-07-29

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 > 12 months
• Subject is >18 years old
• Etiology of brain injury:
• stroke
• carbon monoxide
• anoxia
• trauma
• Must be able to equalize ears, or have tympanostomy tubes
• Willingness to complete outcome measures and comply with the research protocols
• Commitment to pay the hospital for hyperbaric oxygen
• Subject is enrolled in Hyperbaric Oxygen and Chronic Stable Brain Injury study-clinical trials government ID# NCT00830453.

You may not qualify if…

• Glasgow Coma Score <13 at the time of consent
• Poorly controlled seizures
• Inability to participate in outcome assessments (eg: blindness, quadraplegia); Claustrophobia
• Inability to equalize ears
• Inability to protect airway, or requiring frequent suctioning
• Tracheostomy
• Women of child-bearing potential or currently pregnant
• Severe psychiatric disorders
• Taking lithium
• Degenerative mental disease
• Chronic debilitating disease
• Heart failure with ejection fraction <50% or inability to lay supine
• Active malignancy, or prior treatment with cisplatin or bleomycin
• Current recreational drug use
• Consumption of more than the equivalent of 12 beers/week habitually
• Prior treatment with hyperbaric oxygen for chronic brain injury within the last year
• Implanted device that is a contra-indication to MRI
• Inability to travel to Las Vegas, either by car or by air
• Serum creatinine greater than the Intermountain Central Lab normal limit
• Unwillingness or inability to have intravenous contrast.

Where it is running

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

Full record on ClinicalTrials.gov

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