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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01126515
Recruitment Status : Completed
First Posted : May 19, 2010
Last Update Posted : July 29, 2020
Deseret Foundation
Information provided by (Responsible Party):
Lindell Weaver, Intermountain Health Care, Inc.

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.

Condition or disease Intervention/treatment
Brain Injury Sequelae Stroke Anoxia Trauma Procedure: Magnetic Resonance Imaging Procedure: Computed Tomography Angiography

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.

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Study Type : Observational
Actual Enrollment : 17 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: MRI & CT Angiogram and Hyperbaric Oxygen in Chronic Stable Brain Injury
Study Start Date : July 2007
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Hyperbaric oxygen
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:
  • MRI
  • fMRI

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.
Other Names:
  • CT
  • CTA

Primary Outcome Measures :
  1. 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).

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults with chronic brain injury who are enrolled in the HYBOBI study.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01126515

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United States, Utah
LDS Hospital
Salt Lake City, Utah, United States, 84143
Sponsors and Collaborators
Intermountain Health Care, Inc.
Deseret Foundation
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Principal Investigator: Susan K Churchill, APRN-NP Intermountain Health Care, Inc.
Principal Investigator: Lindell K Weaver, MD Intermountain Health Care, Inc.
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Responsible Party: Lindell Weaver, Medical Director, Hyperbaric Medicine, Intermountain Health Care, Inc. Identifier: NCT01126515    
Other Study ID Numbers: 1004120
First Posted: May 19, 2010    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020
Keywords provided by Lindell Weaver, Intermountain Health Care, Inc.:
brain injury
Additional relevant MeSH terms:
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Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Signs and Symptoms, Respiratory