Hyperbaric Oxygen Therapy for Veterans With TBI and PCS: A Biomarker Study
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSummit Hyperbarics and Wellness
About this trial
The goal of this study is to examine changes in blood biomarkers following hyperbaric oxygen therapy (HBOT) in military veterans with traumatic brain injury and persistent post-concussive symptoms. The main questions it aims to answer are:
1. Does HBOT produce measurable changes in inflammatory, neurotrophic, and neuronal injury biomarkers from baseline to completion of a 40-session treatment protocol in veterans with TBI and PCS? 2. Does the presence of comorbid PTSD influence biomarker responses to HBOT among veterans with TBI and PCS?
Participants will:
Complete medical and behavioral health evaluations to determine eligibility. Provide blood samples before treatment and after the final session. Receive 40 HBOT sessions at 2.0 ATA, generally two sessions per day with at least four hours between sessions.
Approximately 34 veterans will participate. All participants will receive HBOT; there is no comparison group.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
At least 18 years of age.
Veteran status
Clinically diagnosed with a TBI by a qualified healthcare professional.
Participants with comorbid post-traumatic stress disorder (PTSD), diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria by a qualified and trained professional, are eligible for enrollment but are not required for study participation.
Disqualifiers
Untreated pneumothorax
History of spontaneous pneumothorax
Asymptomatic pulmonary lesions on chest x-ray
Uncontrollable high fever (greater than 39C)
Trial design
Design model
Single group
Treatments tested in this trial
Hyperbaric Oxygen Therapy (HBOT)
DrugHyperbaric Oxygen Therapy (HBOT): Participants will complete 40 sessions at 2.0 atmospheres absolute (ATA). Each session includes two 30-minute periods of breathing 100% oxygen, separated by a 5-minute air break. Sessions are generally scheduled twice daily with at least four hours between them.
Treatment groups
34 Participants
are divided into 1 treatment groupGroup A: Hyperbaric Oxygen Therapy (HBOT) - 40 SessionsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in blood C-reactive protein (CRP) concentration
Difference in CRP concentration between baseline and completion of 40 HBOT sessions.
Time frame
Baseline and after completion of 40 HBOT sessions (approximately 4 weeks).2
Change in blood interleukin-1 (IL-1) concentration
Difference in IL-1 concentration between baseline and completion of 40 HBOT sessions.
Time frame
Baseline and after completion of 40 HBOT sessions (approximately 4 weeks).3
Change in blood interleukin-6 (IL-6) concentration
Difference in IL-6 concentration between baseline and completion of 40 HBOT sessions.
Time frame
Baseline and after completion of 40 HBOT sessions (approximately 4 weeks).4
Change in blood interleukin-10 (IL-10) concentration
Difference in IL-10 concentration between baseline and completion of 40 HBOT sessions.
Time frame
Baseline and after completion of 40 HBOT sessions (approximately 4 weeks).Sponsors and contacts
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Source ClinicalTrials.gov