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

Stroke Clinical Trial

— HYBOBI-MRI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01126515
• Other study ID #: 1004120
• Status: Completed
• Start date: July 2007
• Est. completion date: June 2010

Study information

• Verified date: July 2020
• Source: Intermountain Health Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anoxia
• Brain Injuries
• Brain Injury
• Hypoxia
• Sequelae
• Stroke
• Trauma
• Wounds and Injuries

Intervention

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).
• 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.

Locations

Country	Name	City	State
United States	LDS Hospital	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
Intermountain Health Care, Inc.	Deseret Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	MRI Results	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	Within 2 weeks of the final hyperbaric session