Hyperbaric Oxygen Treatment for Veterans With Traumatic Brain Injury
University of South Florida
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
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 medical history, and surveys to learn about symptoms related to the participant's mood, sleep, pain, behaviors (e.g. drug and alcohol use), and life satisfaction. Some surveys may be administered via an interview or as an electronic survey. After Baseline A assessments are completed, the investigators will determine if the participant meets the initial criteria to continue participation. Baselin…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
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.…
Interventions
- DrugOxygen 99.7 %
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.
- DrugOxygen 21 %
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.
Location
- University of South FloridaTampa, Florida