Status:
RECRUITING
Hyperbaric Oxygen Treatment for Veterans With Traumatic Brain Injury
Lead Sponsor:
University of South Florida
Collaborating Sponsors:
James A. Haley Veterans' Hospital (JAHVH)
Conditions:
Traumatic Brain Injury
Military Operations
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 Vetera...
Detailed Description
Participants who consent to the study will undergo a comprehensive baseline assessment in two sessions. Baseline A. This visit will involve questions about the participant's brain injury and relevant...
Eligibility Criteria
Inclusion
- U.S. Service Members and Veterans, between 18 and 75 years of age
- Ability to read, write, and speak English.
- Ability to provide informed consent.
- 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).
- 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.
- Able to tolerate the HBOT environment lying down for one hour.
Exclusion
- Received HBOT within the last 3 months.
- Concurrently enrolled in another clinical trial.
- Pregnancy or plans to become pregnant during the study period.
- Lactating
- History of retinal repair
- Malignancy:
- Active
- Tumor-related chemotherapy within the prior 6 months
- Therapeutic radiation to the central nervous system within the prior year
- 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?
- Chronic use of supplemental oxygen or hypoxemia while breathing room air.
- Untreated asthma/Bronchial obstruction/pulmonary blebs, recent/untreated pneumothorax
- Congestive heart failure with ejection fraction \< 40%
- Any implanted devices not cleared for hyperbaric pressurization\*.
- Epilepsy and/ or seizures
- Scuba diving within the previous month
- Current suicidal intent as measured by ≥ 3 on the Columbia-Suicide Severity Rating Scale Screener
- Trapped gas observed indicating Bronchospasm present Tension Pneumothorax
- Evidence of Noncompliant TM (Until corrected)
- Evidence of Pneumothorax
- Evidence of Upper Respiratory Tract Infections
- Signs and symptoms of viral infections, such as high fevers
- Emphysema with CO2 retention
- Optic Neuritis
- Congenital spherocytosis
- History of middle ear surgery / disorders
- Pneumocephalus
- Optional stool samples will not be collected if someone has diarrhea, vomiting, and took antibiotics in the past 30 days.
- Antabuse because it predisposes to oxygen toxicity.
- 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.
- Inability to complete MRIs (e.g., claustrophobia, pacemaker, ferromagnetic implants)\* Exclusion criteria for fMRI optional sub-study only
Key Trial Info
Start Date :
September 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 15 2029
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT06581003
Start Date
September 18 2024
End Date
August 15 2029
Last Update
November 19 2025
Active Locations (1)
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1
University of South Florida
Tampa, Florida, United States, 33612