Traumatic Brain Injury (TBI) PatientsPhase 2NCT07849465
Hyperbaric Oxygen Therapy for Veterans With TBI and PCS: A Biomarker Study
A Phase 2 study testing Hyperbaric Oxygen Therapy (HBOT) in people with Traumatic Brain Injury (TBI) Patients and Post Concussive Symptoms, run by Summit Hyperbarics and Wellness at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Traumatic Brain Injury (TBI) Patients, Post Concussive Symptoms, PTSD
- What is being tested?
- Hyperbaric Oxygen Therapy (HBOT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 1 Oct 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 35Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Summit Hyperbarics and Wellness
Boise, Idaho, 83716
Troy Nickel, Ph.D., 208-813-9541, tnickel@shwidaho.org
About this study
Official title: Neuroinflammatory and Neuroinjury Biomarker Dynamics Following Hyperbaric Oxygen Therapy in Veterans With Traumatic Brain Injury and Persistent Post-Concussive Symptoms
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:
- 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?
- Does the presence of comorbid PTSD influence biomarker responses to HBOT among veterans with TBI and PCS?
Read more
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.
Read the detailed description
This prospective, single-group study will evaluate changes in blood biomarkers following hyperbaric oxygen therapy (HBOT) in approximately 34 military veterans with a history of traumatic brain injury (TBI) and persistent post-concussive symptoms (PCS). The primary objective is to assess changes from baseline to completion of treatment in biomarkers associated with inflammation (CRP, IL-1, IL-6, IL-10, and TNF-α), neurotrophic activity (BDNF), and neuronal injury (NfL, GFAP, BD-tau, and UCH-L1). An exploratory objective is to assess whether biomarker changes differ between participants with and without comorbid post-traumatic stress disorder (PTSD).
Before treatment, participants will undergo medical and behavioral health evaluations to determine their suitability for HBOT. Eligible participants will complete a baseline blood draw for biomarker analysis and standard laboratory testing. Demographic, military service, and relevant clinical information will also be collected.
All participants will receive 40 HBOT sessions in a multiplace chamber at 2.0 atmospheres absolute (ATA). During each session, participants will breathe 100% oxygen for two 30-minute periods separated by a 5-minute air break. Sessions will be scheduled twice daily, Monday through Friday, with at least four hours between sessions. Blood collection and standard laboratory testing will be repeated after the 40-session protocol.
The study will use a pretest-posttest design without randomization or a control group. Within-participant biomarker changes will be evaluated using paired statistical tests, with adjustments for multiple comparisons in the primary biomarker analyses. Comparisons by comorbid PTSD status and associations between biomarker changes and clinical outcomes will be exploratory. Because all participants receive HBOT, observed changes cannot be attributed to HBOT alone.
- Being tested
- Hyperbaric Oxygen Therapy (HBOT)
- Keywords
- Traumatic brain injury (TBI), Post-concussive symptoms (PCS), Post-traumatic stress disorder, Veterans, Hyperbaric Oxygen Therapy (HBOT), Blood biomarkers, Neuroinflammation, Neuronal Injury
- Medical subject headings
- Brain Injuries, Traumatic, Post-Concussion Syndrome, Stress Disorders, Post-Traumatic, Neuroinflammatory Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric Oxygen Therapy (HBOT)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Hyperbaric Oxygen Therapy (HBOT) - 40 Sessions | Experimental | Participants in this arm will receive 40 hyperbaric oxygen therapy (HBOT) sessions in a multiplace chamber at 2.0 atmospheres absolute (ATA). Each session will include two 30-minute periods of breathing 100% oxygen, separated by a 5-minute air break. Sessions will occur twice daily, Monday through Friday, with at least four hours between sessions. Receives: Drug: Hyperbaric Oxygen Therapy (HBOT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood C-reactive protein (CRP) concentration
Difference in CRP concentration between baseline and completion of 40 HBOT sessions.
Measured: Baseline and after completion of 40 HBOT sessions (approximately 4 weeks).
Change in blood interleukin-1 (IL-1) concentration
Difference in IL-1 concentration between baseline and completion of 40 HBOT sessions.
Measured: Baseline and after completion of 40 HBOT sessions (approximately 4 weeks).
Change in blood interleukin-6 (IL-6) concentration
Difference in IL-6 concentration between baseline and completion of 40 HBOT sessions.
Measured: Baseline and after completion of 40 HBOT sessions (approximately 4 weeks).
Change in blood interleukin-10 (IL-10) concentration
Difference in IL-10 concentration between baseline and completion of 40 HBOT sessions.
Measured: Baseline and after completion of 40 HBOT sessions (approximately 4 weeks).
Change in blood tumor necrosis factor-alpha (TNF-α) concentration
Difference in TNF-α concentration between baseline and completion of 40 HBOT sessions.
Measured: Baseline and after completion of 40 HBOT sessions (approximately 4 weeks).
Change in blood brain-derived neurotrophic factor (BDNF) concentration
Difference in BDNF concentration between baseline and completion of 40 HBOT sessions.
Measured: Baseline and after completion of 40 HBOT sessions (approximately 4 weeks).
Change in blood neurofilament light chain (NfL) concentration
Difference in NfL concentration between baseline and completion of 40 HBOT sessions.
Measured: Baseline and after completion of 40 HBOT sessions (approximately 4 weeks).
Change in blood glial fibrillary acidic protein (GFAP) concentration
Difference in GFAP concentration between baseline and completion of 40 HBOT sessions.
Measured: Baseline and after completion of 40 HBOT sessions (approximately 4 weeks)
Change in blood brain-derived tau (BD-tau) concentration
Difference in BD-tau concentration between baseline and completion of 40 HBOT sessions.
Measured: Baseline and after completion of 40 HBOT sessions (approximately 4 weeks).
Change in blood ubiquitin C-terminal hydrolase L1 (UCH-L1) concentration
Difference in UCH-L1 concentration between baseline and completion of 40 HBOT sessions.
Measured: Baseline and after completion of 40 HBOT sessions (approximately 4 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain Injury (TBI) PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Summit Hyperbarics and Wellness
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steve Wyman, Summit Hyperbarics and Wellness
- Investigators
- Steve Wyman, MD, Principal investigator, Summit Hyperbarics and Wellness
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07849465
- Sponsor's protocol ID
- HBOT-VET-2026-001
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no current plan to share IPD with researchers outside the study team. Given the small study population and the combination of sensitive clinical and military service information collected, participant-level data sharing could increase the risk of re-identification. Study findings will be reported in aggregate.