Treatment of U.S. Veterans With Mild Traumatic Brain Injury With Hyperbaric Oxygen Therapy

NCT ID: NCT06665633

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-07
• Study Completion Date: 2025-07-01

Brief Summary

Mild traumatic brain (mTBI) injury affects 400,000 U.S. Veterans resulting in physical, cognitive and mental health symptoms. The Department of Defense (DoD) reported 26 suicides a day from mTBI despite ongoing care for the Veterans. The purpose of this pilot research study is to evaluate the effect of treating Veterans suffering from mTBI or persistent post-concussion syndrome with hyperbaric oxygen therapy (HBOT).

Detailed Description

In 40 male U.S. Veterans, who have had chronic mTBI for at least six months, the effect of HBOT will be measured in this pilot study with online questionnaires before and after HBOT to measure mental health issues (e.g. depression) and brain function (e.g. memory). The questionnaires will be repeated at 6 and 12 months after HBOT. Brain SPECT (single-photon emission computerized tomography) scans, will measure blood flow to the brain's injured areas before and after HBOT. Quantitative Electroencephalography (QEEG)) will measure brain electrical signals before and after HBOT. An overnight sleep study will measure the quality and stages of sleep pre- and post-HBOT. Blood tests will measure inflammation and cellular mitochondrial function (energy production by the cell) before and after HBOT.

Conditions

Mild Traumatic Brain Injury; Hyperbaric Oxygen Therapy; Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment of U.S. Veterans with mild traumatic brain injury with hyperbaric oxygen therapy

Pilot Study - A total of 40 HBOT treatments at 1.5 atmospheres absolute (ATA) for a dive time of 60 minutes, twice a day Monday through Friday. The treatments were separated by an air break of 4 hours on the same day. Measurements of the effectiveness of HBOT in mTBI done before and after HBOT.

Group Type: OTHER

Oxygen 100 % Gas for Inhalation

Intervention Type: DRUG

Oxygen 100% Gas for Inhalation in Hyperbaric Oxygen Therapy Chamber at 1.5 ATA

Hyperbaric Oxygen Therapy Chamber

Intervention Type: DEVICE

Hyperbaric Oxygen Therapy, 40 treatments, at 1.5 ATA and 100% Oxygen

Interventions

Oxygen 100 % Gas for Inhalation

Oxygen 100% Gas for Inhalation in Hyperbaric Oxygen Therapy Chamber at 1.5 ATA

Intervention Type: DRUG

Hyperbaric Oxygen Therapy Chamber

Hyperbaric Oxygen Therapy, 40 treatments, at 1.5 ATA and 100% Oxygen

Intervention Type: DEVICE

Other Intervention Names

Oxygen

Eligibility Criteria

Inclusion Criteria

• A male U.S. Veteran, suffer from mild traumatic brain injury characterized by:

1. a confused or disoriented state which lasts less than 24 hours

2. loss of consciousness for up to 30 minutes

3. memory loss lasting less than 24 hours. In good health prior to mild traumatic brain injury.

Exclusion Criteria

An individual is ineligible to participate if does not meet the criteria for mild traumatic brain injury and if any of the following apply:

1. Female gender due to small pilot study and hormonal changes in women.

2. Current treated or untreated major depression with psychotic or melancholic features, schizophrenia, bipolar disorder, delusional disorders, dementias of any type, and alcoholism or drug abuse

3. Current heavy use of alcohol or tobacco use (self-report in last 6 months)

4. Current organ failure (as determined by self-report)

5. Current treated or untreated rheumatologic and inflammatory disorders, as determined by medical diagnosis of one or more of the following: osteoarthritis, rheumatoid arthritis, lupus erythematosus, spondyloarthropathies - ankylosing spondylitis and psoriatic arthritis, Sjogren's syndrome, gout, scleroderma, infectious arthritis, and polymyalgia rheumatica

6. Chronic active infections such as HIV, hepatitis B, and hepatitis C (self-report)

7. History of organ transplant (self-report)

8. Current primary sleep disorders such as insomnia, sleep related breathing disorders, etc.

(self-report)

9. Any allergic disease (self-report) such as allergic asthma

10. Use of medications that could affect immune function (e.g., steroids, immunosuppressants) (self-report)

11. Renal insufficiency

12. Hepatic insufficiency

14. History of moderate to severe traumatic brain injury or TBI requiring hospitalization in the past five years.

15. Unstable PTSD or PTSD requiring hospitalization in the past 5 years (stable PTSD is allowed) - this is to reduce the risk of a claustrophobic triggering of PTSD symptoms.

(limits generalizability of results to mild/moderate stable PTSD)

16. Are scheduled for surgery during time of hyperbaric oxygen treatments.

Contraindication for HBOT Therapy: untreated collapsed lung.

Relative contraindications for HBOT Therapy: Includes pulmonary diseases including chronic obstructive lung disease, an air blister in the lung that appears on a chest radiograph but does not result in symptoms, upper respiratory or sinus infections, recent ear or thoracic surgery, uncontrolled fever, and claustrophobia. However, these are relative contraindications, which should not deter clinicians from using HBOT to treat patients with severe neurological injuries or other life or limb threatening conditions. The adverse effects of several medications are thought to be increased by HBOT, including bleomycin and doxorubicin. Other exclusions from participation includes pregnancy and participating in another interventional clinical trial of an investigational therapy within 30 days of consent or scheduled for surgery.

Contraindication for brain SPECT scan: Known allergy to radioactive tracer material.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Nova Southeastern University

OTHER

Sponsor Role: lead

Responsible Party

Alison Bested

Alison C. Bested MD, FRCPC. Associate Professor, Chair Hyperbaric Medicine, Nova Southeastern University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alison C Bested, MD FRCPC

Role: PRINCIPAL_INVESTIGATOR

Nova Southeastern University

Locations

Nova Southeastern University

Fort Lauderdale, Florida, United States

Countries

United States

Other Identifiers

IRB#: 2021-406

Identifier Type: -

Identifier Source: org_study_id