NCT06581003 Hyperbaric Oxygen Treatment for Veterans With Traumatic Brain Injury
| NCT ID | NCT06581003 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of South Florida |
| Condition | Traumatic Brain Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 420 participants |
| Start Date | 2024-09-18 |
| Primary Completion | 2028-08-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 420 participants in total. It began in 2024-09-18 with a primary completion date of 2028-08-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this blinded, adaptive, randomized, placebo-controlled clinical trial is to investigate the use of hyperbaric oxygen as a therapy to treat mild to moderate traumatic brain injury in Veterans and active military. The main questions it aims to answer are: * Does Hyperbaric Oxygen Therapy (HBOT) reduce neurobehavioral symptoms? (Aim 1) * How many HBOT sessions are needed to achieve a significant reduction in neurobehavioral symptoms? (Aim 2) * Does HBOT reduce posttraumatic stress disorder (PTSD) symptoms? (Aim 3) Exploratory objectives will explore if there are changes in: 1.) cognitive functioning using neuropsychological tests and the National Institutes of Health (NIH) toolbox, 2.) inflammation biomarkers in blood, 3.) microbiome in stool samples, 4.) electroencephalogram (EEG), 5.) sleep characteristics, and 6.) fMRI. Research will compare HBOT therapy to a placebo condition to see if HBOT works to treat neurobehavioral symptoms. The placebo condition is a chamber that remains unpressurized and has 21% oxygen. Participants will: 1. Complete baseline assessments to determine eligibility. 2. Attend 40 sessions of HBOT or placebo (normal air) within 12 weeks. 3. Complete questionnaires and interviews throughout the course of the study. 4. Complete a 2-week post treatment visit
Eligibility Criteria
Inclusion Criteria: 1. U.S. Service Members and Veterans, between 18 and 75 years of age 2. Ability to read, write, and speak English. 3. Ability to provide informed consent. 4. History of TBI. Participants must have a minimum of 1 year post injury and a TBI classified as mild to moderate as determined by with the Ohio State University TBI Identification Method (Bogner, 2009). 5. Experiencing chronic symptoms of TBI as determined by at least a NSI total score of ≥22 (based on previous work using this score; Harch et al., 2020. 6. Able to tolerate the HBOT environment lying down for one hour. Exclusion Criteria: 1. Received HBOT within the last 3 months. 2. Concurrently enrolled in another clinical trial. 3. Pregnancy or plans to become pregnant during the study period. 4. Lactating 5. History of retinal repair 6. Malignancy: 1. Active 2. Tumor-related chemotherapy within the prior 6 months 3. Therapeutic radiation to the central nervous system within the prior year 7. Current diagnosis of bipolar disorder type I or schizophrenia as determined by responses to inquiry: Have you ever been diagnosed or prescribed medications for bipolar disorder or schizophrenia? 8. Chronic use of supplemental oxygen or hypoxemia while breathing room air. 9. Untreated asthma/Bronchial obstruction/pulmonary blebs, recent/untreated pneumothorax 10. Congestive heart failure with ejection fraction \< 40% 11. Any implanted devices not cleared for hyperbaric pressurization\*. 12. Epilepsy and/ or seizures 13. Scuba diving within the previous month 14. Current suicidal intent as measured by ≥ 3 on the Columbia-Suicide Severity Rating Scale Screener 15. Trapped gas observed indicating Bronchospasm present Tension Pneumothorax 16. Evidence of Noncompliant TM (Until corrected) 17. Evidence of Pneumothorax 18. Evidence of Upper Respiratory Tract Infections 19. Signs and symptoms of viral infections, such as high fevers 20. Emphysema with CO2 retention 21. Optic Neuritis 22. Congenital spherocytosis 23. History of middle ear surgery / disorders 24. Pneumocephalus 25. Optional stool samples will not be collected if someone has diarrhea, vomiting, and took antibiotics in the past 30 days. 26. Antabuse because it predisposes to oxygen toxicity. 27. Other medications that would predispose to oxygen toxicity or known to increase drug toxicity will also be excluded. These are: Disulfuram, Acetazolamide, Sulfamylon; bleomycin, cisplatin, and doxyrubicin. 28. Inability to complete MRIs (e.g., claustrophobia, pacemaker, ferromagnetic implants)\* Exclusion criteria for fMRI optional sub-study only
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06581003 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Traumatic Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06581003 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 420 participants.
Is NCT06581003 currently recruiting?
Yes, NCT06581003 is actively recruiting participants. Contact the research team at erikv@usf.edu for enrollment information.
Where is the NCT06581003 trial being conducted?
This trial is being conducted at Tampa, United States.
Who is sponsoring the NCT06581003 clinical trial?
NCT06581003 is sponsored by University of South Florida. The trial plans to enroll 420 participants.