Actively Recruiting
Hyperbaric Oxygen Treatment for Veterans With Traumatic Brain Injury
Led by University of South Florida · Updated on 2025-11-19
420
Participants Needed
1
Research Sites
256 weeks
Total Duration
On this page
Sponsors
U
University of South Florida
Lead Sponsor
J
James A. Haley Veterans' Hospital (JAHVH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Hyperbaric Oxygen Treatment for Veterans With Traumatic Brain Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 mild to moderate traumatic brain injury at least 1 year post injury as determined by the Ohio State University TBI Identification Method
- Experiencing chronic symptoms of TBI with a Neurobehavioral Symptom Inventory total score of 22 or higher
- Able to tolerate lying down in the hyperbaric oxygen therapy environment for one hour
You will not qualify if you...
- Received hyperbaric oxygen therapy within the last 3 months
- Currently enrolled in another clinical trial
- Pregnant or planning to become pregnant during the study period
- Lactating
- History of retinal repair
- Active malignancy or recent tumor-related chemotherapy within 6 months
- Therapeutic radiation to the central nervous system within the prior year
- Current diagnosis of bipolar disorder type I or schizophrenia
- Chronic use of supplemental oxygen or low oxygen levels while breathing room air
- Untreated asthma, bronchial obstruction, pulmonary blebs, or recent/untreated pneumothorax
- Congestive heart failure with ejection fraction below 40%
- Implanted devices not cleared for hyperbaric pressurization
- Epilepsy or seizures
- Scuba diving within the previous month
- Current suicidal intent as measured by a score of 3 or higher on the Columbia-Suicide Severity Rating Scale Screener
- Bronchospasm, tension pneumothorax, or trapped gas present
- Noncompliant tympanic membrane (ear drum) until corrected
- Pneumothorax
- Upper respiratory tract infections
- Signs and symptoms of viral infections such as high fever
- Emphysema with CO2 retention
- Optic neuritis
- Congenital spherocytosis
- History of middle ear surgery or disorders
- Pneumocephalus
- Diarrhea, vomiting, or antibiotic use in past 30 days if participating in stool sample collection
- Use of Antabuse or medications that increase oxygen toxicity risk (Disulfuram, Acetazolamide, Sulfamylon, bleomycin, cisplatin, doxyrubicin)
- Inability to complete MRI scans due to claustrophobia, pacemaker, or ferromagnetic implants (for fMRI optional sub-study)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of South Florida
Tampa, Florida, United States, 33612
Actively Recruiting
Research Team
E
Erik Velasquez
CONTACT
R
Rachel A Karlnoski, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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