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

This study has been completed.
Sponsor:
Collaborator:
Deseret Foundation
Information provided by:
Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier:
NCT01126515
First received: March 1, 2010
Last updated: March 15, 2011
Last verified: March 2011
  Purpose

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 Intervention Phase
Brain Injury
Sequelae Aspects
Stroke
Anoxia
Trauma
Procedure: Magnetic Resonance Imaging
Procedure: Computed Tomography Angiography
Phase 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: MRI & CT Angiogram and Hyperbaric Oxygen in Chronic Stable Brain Injury

Resource links provided by NLM:


Further study details as provided by Intermountain Health Care, Inc.:

Primary Outcome Measures:
  • Auditory functional magnetic resonance imaging (fMRI) activation [ Time Frame: Within 2 weeks of final hyperbaric session ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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:
  • MRI Results [ Time Frame: Within 2 weeks of the final hyperbaric session ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 20
Study Start Date: July 2007
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adults with chronic brain injury who are enrolled in the HYBOBI study.

Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01126515

Locations
United States, Utah
LDS Hospital
Salt Lake City, Utah, United States, 84143
Sponsors and Collaborators
Intermountain Health Care, Inc.
Deseret Foundation
Investigators
Principal Investigator: Susan K Churchill, APRN-NP Intermountain Health Care, Inc.
Principal Investigator: Lindell K Weaver, MD Intermountain Health Care, Inc.
  More Information

No publications provided

Responsible Party: Susan K. Churchill, APRN-NP, Clinical Coordinator, Intermountain Healthcare
ClinicalTrials.gov Identifier: NCT01126515     History of Changes
Other Study ID Numbers: 1004120
Study First Received: March 1, 2010
Last Updated: March 15, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Intermountain Health Care, Inc.:
brain injury
sequelae
stroke
anoxia
trauma

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on October 29, 2014