- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01126515
Functional and Anatomical Magnetic Resonance Imaging (MRI) of Chronic Brain Injury and Hyperbaric Oxygen (HBO2) Study Subjects (HYBOBI-MRI)
MRI & CT Angiogram and Hyperbaric Oxygen in Chronic Stable Brain Injury
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Utah
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Salt Lake City, Utah, United States, 84143
- LDS Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
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.
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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:
Computed tomography angiography (CTA) with intravenous (IV) contrast will be performed on a 320 head computed tomography (CT) scanner, assessing brain perfusion.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
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Within 2 weeks of final hyperbaric session
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Computed tomography angiography (CTA) Brain Perfusion
Time Frame: Within 2 weeks of the final hyperbaric session
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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.
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Within 2 weeks of the final hyperbaric session
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MRI Results
Time Frame: Within 2 weeks of the final hyperbaric session
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Within 2 weeks of the final hyperbaric session
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Susan K Churchill, APRN-NP, Intermountain Health Care, Inc.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1004120
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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