MRI & CT Angiogram and Hyperbaric Oxygen in Chronic Stable Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Auditory functional magnetic resonance imaging (fMRI) activation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has had a brain injury > 12 months
- •Subject is >18 years old
- •Etiology of brain injury:
- •carbon monoxide
- •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.
排除标准
- •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.
结局指标
主要结局
Auditory functional magnetic resonance imaging (fMRI) activation
时间窗: 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).
Computed tomography angiography (CTA) Brain Perfusion
时间窗: 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.
次要结局
- MRI Results(Within 2 weeks of the final hyperbaric session)
研究者
Lindell Weaver
Medical Director, Hyperbaric Medicine
Intermountain Health Care, Inc.