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

Study Overview
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Brief Summary
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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.

Detailed Description
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In an ongoing feasibility study (HYBOBI), brain-injured subjects are exposed to hyperbaric oxygen at 1.5 atmospheres for 60 minutes. They receive this exposure five days per week, and receive 60 total sessions. Prior to hyperbaric oxygen, these study subjects have neurologic, cognitive, and functional measures. The measures are repeated at the conclusion of 60 hyperbaric oxygen sessions, and again six months later. The goal of the HYBOBI feasibility study is to learn about these patients and determine possible hyperbaric oxygen effects, if any, to prepare for a blinded randomized controlled clinical trial. This study adds an imaging component to the HYBOBI study, further investigating brain changes in participants. Participants will undergo Brain MRI (Magnetic Resonance Imaging) using a 3 tesla magnet, and Brain CT (Computed Tomography) Angiogram. Subjects will undergo imaging before receiving hyperbaric oxygen and within 2 weeks of completion of the 60 hyperbaric sessions.

Official Title
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MRI & CT Angiogram and Hyperbaric Oxygen in Chronic Stable Brain Injury

Conditions
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Brain Injury, Sequelae, Stroke, Anoxia, Trauma

Intervention / Treatment
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* Procedure: Magnetic Resonance Imaging
* Procedure: Computed Tomography Angiography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hyperbaric oxygen<br>In this open-label feasibility study, all subjects will receive 60 hyperbaric oxygen sessions (100% oxygen, 1.5 atmospheres absolute (atm abs), for 60 minutes), delivered daily, five days per week. | Procedure: Magnetic Resonance Imaging<br>* Imaging of the brain without gadolinium will be performed with a 3 Tesla magnetic resonance (MR) System (Intera Achieva 3T; Philips Medical Systems). The protocol will include anatomical sequences, a diffusion tensor imaging sequence with fiber tracking, and auditory, visual, and motor functional magnetic resonance imaging (MRI).<br>* Other names: fMRI;Procedure: Computed Tomography Angiography<br>* Computed tomography angiography (CTA) with intravenous (IV) contrast will be performed on a 320 head computed tomography (CT) scanner, assessing brain perfusion.<br>* Other names: CTA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Auditory functional magnetic resonance imaging (fMRI) activation | The first prime outcome measure will be auditory functional magnetic resonance imaging (fMRI) activation, comparing post-hyperbaric oxygen to pre-hyperbaric oxygen. This is a categorical variable: absent, mild, moderate, normal, and increasing. We will look at the difference between pre-hyperbaric (pre-HBO2) and post-hyperbaric (post-HBO2) scans graphically and descriptively, with the percentage of patients who show any improvement (any change towards normal). | Within 2 weeks of final hyperbaric session | 
| Computed tomography angiography (CTA) Brain Perfusion | Pre-hyperbaric (pre-HBO2) computed tomography angiography (CTA) results will be determined to be normal or abnormal, and then compared to the post-hyperbaric (post-HBO2) scan, which will be scored as better, worse, or no change. | Within 2 weeks of the final hyperbaric session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI Results | Cortical activation (amount and location) for motor, visual, and olfactory fMRI. Diffusion tensor imaging (fractional anisotropy differences, number of fiber tracts) within the Corpus Callosum | Within 2 weeks of the final hyperbaric session | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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brain injury, sequelae, stroke, anoxia, trauma