Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2025-12-24 @ 7:23 PM
NCT ID:
NCT06581003
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06581003
Study Brief:
Protocol Section:
NCT06581003