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

NCT01126515 | Completed

• 1 other identifier: 1004120
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Injury; Sequelae; Stroke; Anoxia; Trauma

Keywords

brain injury; sequelae; stroke; anoxia; trauma

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  Within 2 weeks of the final hyperbaric session

Secondary Outcomes (1)

• MRI Results

  Within 2 weeks of the final hyperbaric session

Study Arms (1)

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; Procedure: Computed Tomography Angiography

Interventions

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).

Also known as: MRI, fMRI

Hyperbaric oxygen

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.

Also known as: CT, CTA

Hyperbaric oxygen

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Intermountain Health Care, Inc.: lead
• Deseret Foundation: collaborator

Study Sites (1)

LDS Hospital

Salt Lake City, Utah, 84143, United States

Location

MeSH Terms

Conditions

Brain Injuries; Stroke; Hypoxia; Wounds and Injuries

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Susan K Churchill, APRN-NP

  Intermountain Health Care, Inc.

  PRINCIPAL INVESTIGATOR

• Lindell K Weaver, MD

  Intermountain Health Care, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Hyperbaric Medicine

Study Record Dates

• First Submitted: March 1, 2010
• First Posted: May 19, 2010
• Study Start: July 1, 2007
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: July 29, 2020

Record last verified: 2020-07

Locations

US (1)