Functional and Anatomical Magnetic Resonance Imaging (MRI) of Chronic Brain Injury and Hyperbaric Oxygen (HBO2) Study Subjects (HYBOBI-MRI)
|ClinicalTrials.gov Identifier: NCT01126515|
Recruitment Status : Completed
First Posted : May 19, 2010
Last Update Posted : March 17, 2011
|Condition or disease||Intervention/treatment||Phase|
|Brain Injury Sequelae Aspects Stroke Anoxia Trauma||Procedure: Magnetic Resonance Imaging Procedure: Computed Tomography Angiography||Phase 2|
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.
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|Official Title:||MRI & CT Angiogram and Hyperbaric Oxygen in Chronic Stable Brain Injury|
|Study Start Date :||July 2007|
|Primary Completion Date :||June 2010|
|Study Completion Date :||June 2010|
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
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).
Other Names:Procedure: Computed Tomography Angiography
Computed tomography angiography (CTA) with intravenous (IV) contrast will be performed on a 320 head computed tomography (CT) scanner, assessing brain perfusion.
- 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.
- MRI Results [ Time Frame: Within 2 weeks of the final hyperbaric session ]
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01126515
|United States, Utah|
|Salt Lake City, Utah, United States, 84143|
|Principal Investigator:||Susan K Churchill, APRN-NP||Intermountain Health Care, Inc.|
|Principal Investigator:||Lindell K Weaver, MD||Intermountain Health Care, Inc.|