Brain InjuryHYBOBI-MRINCT01126515
Functional and Anatomical Magnetic Resonance Imaging (MRI) of Chronic Brain Injury and Hyperbaric Oxygen (HBO2) Study Subjects
An observational study of Brain Injury and Sequelae, run by Intermountain Health Care, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Brain Injury, Sequelae, Stroke
- What is being tested?
- Magnetic Resonance Imaging and Computed Tomography Angiography
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Jun 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with chronic brain injury who are enrolled in the HYBOBI study.
Who may be able to join
- Subject has had a brain injury > 12 months
- Subject is >18 years old
- Etiology of brain injury:
- stroke
- carbon monoxide
- anoxia
Show all 11Show fewer
- 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.
Who cannot join
- 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
Show all 20Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MRI & CT Angiogram and Hyperbaric Oxygen in Chronic Stable Brain Injury
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.
Read the 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.
- Conditions
- Brain Injury, Sequelae, Stroke, Anoxia, Trauma
- Being tested
- Magnetic Resonance Imaging, Computed Tomography Angiography
- Keywords
- brain injury, sequelae, stroke, anoxia, trauma
- Medical subject headings
- Brain Injuries, Stroke, Hypoxia, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingProcedure or surgery
Also called MRI, fMRI
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).
Computed Tomography AngiographyProcedure or surgery
Also called CT, CTA
Computed tomography angiography (CTA) with intravenous (IV) contrast will be performed on a 320 head computed tomography (CT) scanner, assessing brain perfusion.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Magnetic Resonance Imaging; Procedure: Computed Tomography Angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Within 2 weeks of the final hyperbaric session
Secondary outcomes (1)
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
Measured: Within 2 weeks of the final hyperbaric session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2010 (estimated)
- Study startJul 2007
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Deseret Foundation
- Responsible party
- Principal investigator, Lindell Weaver, Intermountain Health Care, Inc.
- Investigators
- Susan K Churchill, APRN-NP, Principal investigator, Intermountain Health Care, Inc.Lindell K Weaver, MD, Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01126515
- Sponsor's protocol ID
- 1004120
- Acronym
- HYBOBI-MRI
- Status last verified
- Jul 2020
- First submitted
- 1 Mar 2010
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI & CT Angiogram and Hyperbaric Oxygen in Chronic Stable Brain Injury
- ClinicalTrials.gov ID
- NCT01126515
- Acronym / sponsor ID
- HYBOBI-MRI / 1004120
- Conditions
- Brain Injury, Sequelae, Stroke, Anoxia, Trauma
- Keywords
- brain injury, sequelae, stroke, anoxia, trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Collaborators
- Deseret Foundation
- Study start
- Jul 2007
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 19 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyperbaric oxygen | – | Procedure: Magnetic Resonance Imaging, Procedure: Computed Tomography AngiographyIn 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with chronic brain injury who are enrolled in the HYBOBI study.
Key inclusion criteria (11 listed)
- Subject has had a brain injury > 12 months
- Subject is >18 years old
- Etiology of brain injury:
- Must be able to equalize ears, or have tympanostomy tubes
- Willingness to complete outcome measures and comply with the research protocols
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance ImagingAlso: MRI, fMRIImaging 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). | Procedure or surgery | Hyperbaric oxygen |
| Computed Tomography AngiographyAlso: CT, CTAComputed tomography angiography (CTA) with intravenous (IV) contrast will be performed on a 320 head computed tomography (CT) scanner, assessing brain perfusion. | Procedure or surgery | Hyperbaric oxygen |
Primary outcome
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.
1 secondary outcome
MRI Results
Time frame: Within 2 weeks of the final hyperbaric session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan K Churchill, APRN-NP principal investigator
Intermountain Health Care, Inc.
Lindell K Weaver, MD principal investigator
Intermountain Health Care, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injury and Sequelae, run by Intermountain Health Care, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Auditory functional magnetic resonance imaging (fMRI) activation (time frame: Within 2 weeks of final hyperbaric session). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2020.