Functional and Anatomical Magnetic Resonance Imaging (MRI) of Chronic Brain Injury and Hyperbaric… (NCT01126515) | Clinical Trial Compass
CompletedNot Applicable
Functional and Anatomical Magnetic Resonance Imaging (MRI) of Chronic Brain Injury and Hyperbaric Oxygen (HBO2) Study Subjects
United States17 participantsStarted 2007-07
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Unwillingne…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Auditory functional magnetic resonance imaging (fMRI) activation
Timeframe: Within 2 weeks of final hyperbaric session