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

NCT ID: NCT01126515

Last Updated: 2020-07-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 17 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2010-06-30

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.

Conditions

Brain Injury; Sequelae; Stroke; Anoxia; Trauma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Magnetic Resonance Imaging

Intervention Type: 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).

Computed Tomography Angiography

Intervention Type: PROCEDURE

Computed tomography angiography (CTA) with intravenous (IV) contrast will be performed on a 320 head computed tomography (CT) scanner, assessing brain perfusion.

Interventions

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).

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

MRI; fMRI; CT; CTA

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Deseret Foundation

OTHER

Sponsor Role: collaborator

Intermountain Health Care, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Lindell Weaver

Medical Director, Hyperbaric Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susan K Churchill, APRN-NP

Role: PRINCIPAL_INVESTIGATOR

Intermountain Health Care, Inc.

Lindell K Weaver, MD

Role: PRINCIPAL_INVESTIGATOR

Intermountain Health Care, Inc.

Locations

LDS Hospital

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

1004120

Identifier Type: -

Identifier Source: org_study_id