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NCT Number: NCT01126515

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Magnetic Resonance Imaging

Procedure

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

Computed Tomography Angiography

Procedure

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 outcomes

  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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Intermountain Health Care, Inc.

Other

Collaborators

  • Deseret Foundation

Registry information

Official study title

MRI & CT Angiogram and Hyperbaric Oxygen in Chronic Stable Brain Injury

Acronym: HYBOBI-MRI

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
May 19, 2010
Registry last updated
Jul 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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