NCT07849465 · Summit Hyperbarics and Wellness
Hyperbaric Oxygen Therapy for Veterans With TBI and PCS: A Biomarker Study
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Hyperbaric Oxygen Therapy (HBOT)
Hyperbaric 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.
Primary outcome measures
Change in blood C-reactive protein (CRP) concentration
Time frame: Baseline and after completion of 40 HBOT sessions (approximately 4 weeks).
Difference in CRP concentration between baseline and completion of 40 HBOT sessions.
Change in blood interleukin-1 (IL-1) concentration
Time frame: Baseline and after completion of 40 HBOT sessions (approximately 4 weeks).
Difference in IL-1 concentration between baseline and completion of 40 HBOT sessions.
Change in blood interleukin-6 (IL-6) concentration
Time frame: Baseline and after completion of 40 HBOT sessions (approximately 4 weeks).
Difference in IL-6 concentration between baseline and completion of 40 HBOT sessions.
Change in blood interleukin-10 (IL-10) concentration
Time frame: Baseline and after completion of 40 HBOT sessions (approximately 4 weeks).
Difference in IL-10 concentration between baseline and completion of 40 HBOT sessions.
Change in blood tumor necrosis factor-alpha (TNF-α) concentration
Time frame: Baseline and after completion of 40 HBOT sessions (approximately 4 weeks).
Difference in TNF-α concentration between baseline and completion of 40 HBOT sessions.
Change in blood brain-derived neurotrophic factor (BDNF) concentration
Time frame: Baseline and after completion of 40 HBOT sessions (approximately 4 weeks).
Difference in BDNF concentration between baseline and completion of 40 HBOT sessions.
Change in blood neurofilament light chain (NfL) concentration
Time frame: Baseline and after completion of 40 HBOT sessions (approximately 4 weeks).
Difference in NfL concentration between baseline and completion of 40 HBOT sessions.
Change in blood glial fibrillary acidic protein (GFAP) concentration
Time frame: Baseline and after completion of 40 HBOT sessions (approximately 4 weeks)
Difference in GFAP concentration between baseline and completion of 40 HBOT sessions.
Change in blood brain-derived tau (BD-tau) concentration
Time frame: Baseline and after completion of 40 HBOT sessions (approximately 4 weeks).
Difference in BD-tau concentration between baseline and completion of 40 HBOT sessions.
Change in blood ubiquitin C-terminal hydrolase L1 (UCH-L1) concentration
Time frame: Baseline and after completion of 40 HBOT sessions (approximately 4 weeks).
Difference in UCH-L1 concentration between baseline and completion of 40 HBOT sessions.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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. 4\. The participant is willing and able to read, understand, and sign an informed consent. Additionally, the participant has clear consciousness and the ability to express self-feelings independently. 6\. Completed psychological measurements (pre-study screening requirement) 7. Presence of clinically significant cognitive and/or PCS symptoms resulting in impairment in occupational, social, and other important areas of functioning, as determined by clinical evaluation. 8\. Sexually active female participants of childbearing potential and sexually active male participants with female partners of childbearing potential must agree to use an acceptable method of contraception for the duration of the study and for 30 days following the final HBOT session. 9\. Stability on any prescribed psychoactive medications and/or other chronic medical medications. Stability is defined as no significant changes in type of dosage within the previous 4-5 weeks, to minimize confounding effects on study outcomes and ensure participant safety.
Exclusion criteria
- Untreated pneumothorax
- History of spontaneous pneumothorax
- Asymptomatic pulmonary lesions on chest x-ray
- Uncontrollable high fever (greater than 39C)
- History of chest or ear surgery
- Congenital spherocytosis
- Any anemia or blood disorder
- Any convulsive disorder
- History of optic neuritis or sudden blindness
- Middle ear infection
- Diabetes mellitus (insulin therapy)
- The participant is pregnant or lactating
- Nicotine use/substance use/addiction
- Acute Hypoglycemia
- Diagnosed Chronic Obstructive Pulmonary Disease (COPD) and Emphysema
- Presenting with symptoms of cough, congestion, vomiting, diarrhea, or open wounds.
- Active malignancy
- Current manic, delusional, or psychotic episodes
- Serious/current suicidal ideations
- Severe or unstable physical disorders or major cognitive deficits
- Inability to attend scheduled clinic visits or comply with study protocols.
- Treated with HBOT for any reason prior to study enrollment.
- Non-English speakers
- History of retinal repair, including laser photocoagulation or retinal detachment surgery.
- History of middle ear surgery, including tympanoplasty, mastoidectomy, or pressure equalization tube placement.
- Age greater than 75 years.
- Use of any of the following medications during the study period: Anti-metabolites (e.g., methotrexate, azathioprine); Chemotherapeutic agents (e.g., cyclophosphamide, cisplatin); Mafenide acetate e.g., Sulfamylon); Disulfiram (e.g, Antabuse); Peripheral vasodilators known to interact with oxygen exposure (e.g., nitroglycerin); and Antibacterial drugs with known HBOT interaction risks.
- Recent vaccination (≤ 1 week), or underlying inflammatory conditions
- Use of systemic corticosteroids or immunomodulatory therapies
- Active or recent infection requiring antibiotics.
- Significant renal or hepatic impairment.
- Regular participation in intense physical training or exercise programs (Defined as endurance events (e.g., triathlons, marathons, ultramarathons, Ironman-level training) or high-intensity interval training (HIIT) programs performed multiple times per week)
- Recent (within 4 weeks prior to baseline) or planned use of antioxidant supplements or high-dose vitamins (Examples include: Vitamin C (\> 500 mg/day), Vitamin E (\>200 IU/day), N-acetylcysteine (NAC) or other thiol-based antioxidants, Alpha-lipoic acid, high-dose multivitamins containing the above doses, or Omega-3 fatty acid concentrates taken specifically for antioxidant/anti-inflammatory purposes)
- Recent participation in other clinical trials that could affect biomarker levels.
- Untreated or severe sleep disorders
Where
- Boise, Idaho
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 30, 2026 · Source of record for eligibility and locations