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Hyperbaric Oxygen for Traumatic and Non-traumatic Brain Injury

CompletedPhase 2NCT01986205
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
A Double-blind Randomized Trial of Hyperbaric Oxygen Versus Sham for Persistent Symptoms After Brain Injury
Conditions
  • Brain Injury, Chronic
Interventions
  • Combination product: Hyperbaric Oxygen
  • Combination product: Minimal pressure air
Sponsor
Lindell Weaver
Organization
Intermountain Health Care, Inc.
Start date
2017-09-06
Primary completion
2022-05-31
Sex
All
Age range
from 18 Years to 70 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
2

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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. * Pregnancy or plans to become pregnant during the study participation period. Women of childbearing potential will be asked to use an acceptable form of birth control during study participation. * Lung disease, such as emphysema, chronic bronchitis, asthma that is not well-controlled, or bullous lung disease that raises the risk for pulmonary barotrauma due to air trapping. * Active malignancy, previous malignancy (except basal cell carcinoma) in the last 5 years, or any prior treatment with bleomycin (Blenoxane). Prior treatment with doxorubicin (Adriamycin) is acceptable as long follow-up echocardiography is normal. * Chronic disease such as heart or renal failure would raise the participant's risk of adverse events during hyperbaric oxygen. * Confounds to the outcome assessments * Inability to speak English as their primary language (English fluency required because many of the outcomes are only in available in English) * Instability with walking requiring more than a cane for assistance * Alcohol …

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01986205