Hyperbaric oxygen therapy for veterans with traumatic brain injury

Hyperbaric Oxygen Treatment for Veterans With Traumatic Brain Injury

This study is testing if hyperbaric oxygen therapy can help veterans and active military personnel with mild to moderate traumatic brain injuries feel better and reduce symptoms of PTSD.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 420 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: University of South Florida (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Tampa, Florida)
• Trial ID: NCT06581003 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of hyperbaric oxygen therapy (HBOT) in treating mild to moderate traumatic brain injury (TBI) in veterans and active military personnel. It is a blinded, adaptive, randomized, placebo-controlled trial that aims to determine if HBOT can reduce neurobehavioral symptoms and PTSD symptoms, as well as explore various cognitive and biological changes. Participants will undergo comprehensive assessments and be randomized to receive either HBOT or a placebo treatment. The study will also evaluate the number of HBOT sessions needed for significant symptom reduction.

Who should consider this trial

Good fit: Ideal candidates are U.S. service members and veterans aged 18 to 75 with a history of mild to moderate traumatic brain injury.

Not a fit: Patients who have received hyperbaric oxygen therapy within the last three months or have certain medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for veterans suffering from traumatic brain injury and related symptoms.

How similar studies have performed: While some studies have explored hyperbaric oxygen therapy for various conditions, this specific application for veterans with TBI is relatively novel.

Eligibility criteria

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.

Exclusion Criteria:

1. Received HBOT within the last 3 months.
2. Concurrently enrolled in another clinical trial.
3. Pregnancy or plans to become pregnant during the study period.
4. Lactating
5. History of retinal repair
6. Malignancy:

   1. Active
   2. Tumor-related chemotherapy within the prior 6 months
   3. Therapeutic radiation to the central nervous system within the prior year
7. Current diagnosis of bipolar disorder type I or schizophrenia as determined by responses to inquiry: Have you ever been diagnosed or prescribed medications for bipolar disorder or schizophrenia?
8. Chronic use of supplemental oxygen or hypoxemia while breathing room air.
9. Untreated asthma/Bronchial obstruction/pulmonary blebs, recent/untreated pneumothorax
10. Congestive heart failure with ejection fraction \< 40%
11. Any implanted devices not cleared for hyperbaric pressurization\*.
12. Epilepsy and/ or seizures
13. Scuba diving within the previous month
14. Current suicidal intent as measured by ≥ 3 on the Columbia-Suicide Severity Rating Scale Screener
15. Trapped gas observed indicating Bronchospasm present Tension Pneumothorax
16. Evidence of Noncompliant TM (Until corrected)
17. Evidence of Pneumothorax
18. Evidence of Upper Respiratory Tract Infections
19. Signs and symptoms of viral infections, such as high fevers
20. Emphysema with CO2 retention
21. Optic Neuritis
22. Congenital spherocytosis
23. History of middle ear surgery / disorders
24. Pneumocephalus
25. Optional stool samples will not be collected if someone has diarrhea, vomiting, and took antibiotics in the past 30 days.
26. Antabuse because it predisposes to oxygen toxicity.
27. Other medications that would predispose to oxygen toxicity or known to increase drug toxicity will also be excluded. These are: Disulfuram, Acetazolamide, Sulfamylon; bleomycin, cisplatin, and doxyrubicin.
28. Inability to complete MRIs (e.g., claustrophobia, pacemaker, ferromagnetic implants)\* Exclusion criteria for fMRI optional sub-study only

Where this trial is running

Tampa, Florida

• University of South Florida — Tampa, Florida, United States (Recruiting)

Study contacts

• Study coordinator: Erik Velasquez

Conditions Traumatic Brain Injury; Military Operations; hyperbaric chamber; neuromodulation