MRI & CT Angiogram and Hyperbaric Oxygen in Chronic Stable Brain Injury
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Brain Injury
- Sponsor
- Intermountain Health Care, Inc.
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Auditory functional magnetic resonance imaging (fMRI) activation
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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
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.
Investigators
Lindell Weaver
Medical Director, Hyperbaric Medicine
Intermountain Health Care, Inc.
Eligibility Criteria
Inclusion Criteria
- •Subject has had a brain injury \> 12 months
- •Subject is \>18 years old
- •Etiology of brain injury:
- •carbon monoxide
- •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
Outcomes
Primary Outcomes
Auditory functional magnetic resonance imaging (fMRI) activation
Time Frame: Within 2 weeks of final hyperbaric session
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).
Computed tomography angiography (CTA) Brain Perfusion
Time Frame: Within 2 weeks of the final hyperbaric session
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.
Secondary Outcomes
- MRI Results(Within 2 weeks of the final hyperbaric session)