Hyperbaric Oxygen Treatment for Veterans With Traumatic Brain Injury
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of South Florida
About this trial
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
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
Received HBOT within the last 3 months.
Concurrently enrolled in another clinical trial.
Pregnancy or plans to become pregnant during the study period.
Lactating
Trial design
Design model
Sequential
Treatments tested in this trial
Oxygen 99.7 %
DrugThe 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.
Oxygen 21 %
DrugThe 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.
Treatment groups
420 Participants
are divided into 2 treatment groupsGroup A: HBOT GroupExperimental treatment 1 intervention
Group B: Placebo/Sham GroupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from Baseline in the Neurobehavioral Symptoms at 2 weeks Post Intervention
Measured by the Neurobehavioral Symptom Inventory (NSI). The severity of each symptom on the NSI is measured using a 5-item scale (0-none to 4-very severe) that asks patients to indicate the extent to which each symptom has disturbed them in the previous 2 weeks. The NSI total score is the sum of severity ratings of the 22 symptoms. Cluster scores (domains: physical, cognitive, affective, and sensory) were derived.
Time frame
at 2 weeks post treatmentSecondary outcomes
1
Change from Baseline in post traumatic stress disorder symptoms at 2 weeks post intervention
measured by the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders - 5 (DSM-5); PTSD Checklist-5 (PCL-5). The PTSD Checklist for DSM-5 (PCL-5) is a self-report measure used to assess the presence and severity of PTSD symptoms based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). A score between 0-80 Higher Scores: Indicate a worse outcome, as they suggest a greater severity of PTSD symptoms. Lower Scores: Indicate a better outcome, as they suggest fewer or less severe PTSD symptom
Time frame
at 2 weeks post treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of South Florida
Lead sponsor
James A. Haley Veterans' Hospital (JAHVH)
Collaborator
Source ClinicalTrials.gov