Hyperbaric Oxygen Treatment for Veterans With Traumatic Brain Injury
University of South Florida
420 participants
Sep 18, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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 Criteria30
- 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.
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Interventions
The experimental group will undergo HBOT in a specialized chamber at a pressure of 2.0 ATA. Oxygen will be delivered at 100% for 60 minutes.
The control group will be placed in the same specialized chamber, but pressure will be 1.0 ATA (normobaric), and oxygen will be delivered at 21% (normal oxygen concentration in room air) for 60 minutes.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06581003