RECRUITING

Hyperbaric Oxygen Treatment for Veterans with Traumatic Brain Injury

Conditions

Traumatic Brain Injury Military Operations hyperbaric chamber neuromodulation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this blinded, adaptive, randomized, placebo-controlled clinical trial is to investigate the use of hyperbaric oxygen as a therapy to treat mild to moderate traumatic brain injury in Veterans and active military. The main questions it aims to answer are: * Does Hyperbaric Oxygen Therapy (HBOT) reduce neurobehavioral symptoms? (Aim 1) * How many HBOT sessions are needed to achieve a significant reduction in neurobehavioral symptoms? (Aim 2) * Does HBOT reduce posttraumatic stress disorder (PTSD) symptoms? (Aim 3) Exploratory objectives will explore if there are changes in: 1.) cognitive functioning using neuropsychological tests and the National Institutes of Health (NIH) toolbox, 2.) inflammation biomarkers in blood, 3.) microbiome in stool samples, 4.) electroencephalogram (EEG), 5.) sleep characteristics, and 6.) fMRI. Research will compare HBOT therapy to a placebo condition to see if HBOT works to treat neurobehavioral symptoms. The placebo condition is a chamber that remains unpressurized and has 21% oxygen. Participants will: 1. Complete baseline assessments to determine eligibility. 2. Attend 40 sessions of HBOT or placebo (normal air) within 12 weeks. 3. Complete questionnaires and interviews throughout the course of the study. 4. Complete a 2-week post treatment visit

Official Title

Hyperbaric Oxygen Treatment for Veterans with Traumatic Brain Injury

Quick Facts

Study Start:2024-09-18

Study Completion:2029-08-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06581003

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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

Inclusion Criteria

Exclusion 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.

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

Contacts and Locations

Study Contact

Dawn Neumann, PhD

CONTACT

813-396-9200

dawnneumann@usf.edu

Rachel A Karlnoski, PhD

CONTACT

7278584224

karlnosk@usf.edu

Study Locations (Sites)

University of South Florida

Tampa, Florida, 33612

United States

Collaborators and Investigators

Sponsor: University of South Florida

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-18

Study Completion Date2029-08-15

Study Record Updates

Study Start Date2024-09-18

Study Completion Date2029-08-15

Terms related to this study

Keywords Provided by Researchers

hyperbaric chamber
neuromodulation

Additional Relevant MeSH Terms

Traumatic Brain Injury
Military Operations