Clinical trial NCT01126515: Functional and Anatomical Magnetic Resonance Imaging (MRI) of Chronic Brain Injury and Hyperbaric Oxygen (HBO2) Study Subjects
Official title: MRI & CT Angiogram and Hyperbaric Oxygen in Chronic Stable Brain Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Injury
Sequelae
Stroke
Anoxia
Trauma
Keywords: brain injury
sequelae
stroke
anoxia
trauma
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
Collaborators: name: Deseret Foundation
First posted: 2010-05-19
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with chronic brain injury who are enrolled in the HYBOBI study.

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.

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 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.

Primary outcomes:
measure: Auditory functional magnetic resonance imaging (fMRI) activation
timeFrame: Within 2 weeks of final hyperbaric session
measure: Computed tomography angiography (CTA) Brain Perfusion
timeFrame: Within 2 weeks of the final hyperbaric session
Secondary outcomes:
measure: MRI Results
timeFrame: Within 2 weeks of the final hyperbaric session
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: LDS Hospital
state: Utah
Study officials:
affiliation: Intermountain Health Care, Inc.
name: Susan K Churchill, APRN-NP
role: PRINCIPAL_INVESTIGATOR
affiliation: Intermountain Health Care, Inc.
name: Lindell K Weaver, MD
role: PRINCIPAL_INVESTIGATOR
References: