CompletedPhase 2

Hyperbaric Oxygen for Traumatic and Non-traumatic Brain Injury

United States49 participantsStarted 2017-09-06

Plain-language summary

The purpose of this study is to examine whether 40 hyperbaric oxygen sessions has effect on long-term symptoms after brain injury. This study will enroll 90 individuals with persistent problems 6 months to 10 years after a brain injury. These individuals will be randomized to receive either oxygen or air in a pressurized hyperbaric chamber. Participants will receive 40 daily hyperbaric chamber sessions. Participants will have a series of tests and questionnaires before they begin their chamber sessions, after they complete 40 sessions, and 6 months after they joined the study. These tests include computer-based and pencil-and-paper questionnaires and thinking tests, brain imaging, a neurological examination, and an eye exam. Participants will also be asked to provide blood for future research. After the 6-month tests are complete, all participants will receive 40 hyperbaric oxygen sessions, then undergo the same tests at 9 months and 12 months.

Who can participate

Age range

18 Years – 70 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: * Adults, age 18-70 years, both men and women * Able to speak and read English as primary language * Able and willing to provide written informed consent for study participation. * Able and willing to complete outcome assessments and provide blood and urine samples as required by the study protocol. * Able to tolerate the chamber environment and hood placement and to equalize middle ear pressure. * Past history of at least one brain injury with persistent symptoms that meets all of the following criteria: * Brain injury of non-stroke etiology that occurred at least 6 months but no more than 10 years prior to enrollment. * At least 3 of the following persistent symptoms from the injury: headaches, dizziness or balance problems, blurred vision, tiredness/fatigue or sleep problems, seizures, remembering things or solving problems, managing stress or emotional upsets, controlling temper/irritability, depression, anxiety, post-traumatic stress, or ringing in the ears. * Normal thyroid stimulating hormone and hematocrit value greater than 35% within the previous 6 months. Exclusion Criteria: * Contraindications to hyperbaric oxygen * Insulin-dependent diabetes mellitus, or diabetes mellitus that is not reasonably controlled. * Uncontrolled seizure disorder (participants must be on therapy and seizure-free for at least 6 months). * Claustrophobia precluding chamber or hood tolerance. * Implanted devices not cleared for hyperbaric pressurization. …

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.

1This trial used hyperbaric oxygen to treat chronic brain injury and measured outcomes using something called the Neurobehavioral Symptom Inventory — can you explain what that inventory measures and whether my specific symptoms would have been captured by it?
2Since this was a Phase 2 trial that has now completed, what do the results suggest about how safe and potentially helpful hyperbaric oxygen therapy was for people with chronic brain injury, and are those findings strong enough to guide my care?
3Hyperbaric oxygen treatments typically require multiple sessions in a pressurized chamber — based on what this trial required, is that kind of treatment schedule realistic for my situation, and are there facilities near me that could provide it?
4Given that this trial is completed but the results may not yet be part of standard care guidelines, would it make more sense for me to pursue conventional treatments first before considering hyperbaric oxygen therapy?
5Are there specific types of brain injury — traumatic versus non-traumatic — where this trial's results seemed more promising, and does my diagnosis fit the profile of patients who appeared to benefit most?

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

Neurobehavioral Symptom Inventory

Timeframe: 13 weeks

Trial details

NCT IDNCT01986205

SponsorLindell Weaver

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-05-31

View on ClinicalTrials.gov More Brain Injury, Chronic trials