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

NCT06665633 | Completed Phase 1 FDA Drug FDA Device

• 1 other identifier: IRB#: 2021-406
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Mild Traumatic Brain Injury; Hyperbaric Oxygen Therapy; Depression

Keywords

Mild Traumatic Brain Injury; Hyperbaric Oxygen Therapy; Brain SPECT Scan; Brodmann Areas; Suicide; Depression

Outcome Measures

Primary Outcomes (1)

• Brain SPECT Scan

  A brain SPECT scan is a type of imaging test that uses a radioactive substance and a special camera to create 3D pictures of the brain. It shows which areas of the brain are functioning the best or worst and how well the blood flows in the brain. The blood flow to the brain was measured pre- and post-HBOT. An infusion of a radioactive tracer, 30 millicurie (mCi) of Tc99m-Ceretec, was injected into the Veteran's IV site. The veteran was placed under the gamma scintillation camera (Siemens E-cam Dual Head) with a low-energy, high-resolution collimator and SPECT images were recorded using the NeuroGam Software Analysis for the numerical calculation of the mean blood flow value for each of the Brodmann Areas - which are the functional areas in the brain.

  pre- HBOT and 4 weeks after HBOT

Secondary Outcomes (28)

• Beck Anxiety Inventory

  pre- HBOT and 1, 6. 12 months after HBOT

• Beck Depression Inventory II

  pre- HBOT and 1, 6. 12 months after HBOT

• Brief Pain Inventory

  pre- HBOT and 1, 6. 12 months after HBOT

• Traumatic Brain Injury Screening Tool

  pre- HBOT

• Davidson Trauma Scale

  pre- HBOT and 1, 6. 12 months after HBOT

Study Arms (1)

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

OTHER

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.

Drug: Oxygen 100 % Gas for Inhalation; Device: Hyperbaric Oxygen Therapy Chamber

Interventions

Oxygen 100 % Gas for Inhalation DRUG

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

Also known as: Oxygen

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

Hyperbaric Oxygen Therapy Chamber DEVICE

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

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A male U.S. Veteran, suffer from mild traumatic brain injury characterized by:
• a confused or disoriented state which lasts less than 24 hours
• loss of consciousness for up to 30 minutes
• memory loss lasting less than 24 hours. In good health prior to mild traumatic brain injury.

You may not qualify if:

• An individual is ineligible to participate if does not meet the criteria for mild traumatic brain injury and if any of the following apply:
• Female gender due to small pilot study and hormonal changes in women.
• 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
• Current heavy use of alcohol or tobacco use (self-report in last 6 months)
• Current organ failure (as determined by self-report)
• 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
• Chronic active infections such as HIV, hepatitis B, and hepatitis C (self-report)
• History of organ transplant (self-report)
• Current primary sleep disorders such as insomnia, sleep related breathing disorders, etc.
• (self-report)
• Any allergic disease (self-report) such as allergic asthma
• Use of medications that could affect immune function (e.g., steroids, immunosuppressants) (self-report)
• Renal insufficiency
• Hepatic insufficiency
• History of moderate to severe traumatic brain injury or TBI requiring hospitalization in the past five years.

Sponsors & Collaborators

• Nova Southeastern University: lead

Study Sites (1)

Nova Southeastern University

Fort Lauderdale, Florida, 33328, United States

Location

MeSH Terms

Conditions

Brain Concussion; Depression; Suicide

Interventions

Oxygen; Gases; Inhalation

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Behavioral Symptoms; Behavior; Self-Injurious Behavior

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Alison C Bested, MD FRCPC

  Nova Southeastern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Alison C. Bested MD, FRCPC. Associate Professor, Chair Hyperbaric Medicine, Nova Southeastern University

Model Details: Pilot study - to study the effect of 40 treatments of hyperbaric oxygen therapy using 100% oxygen and increased atmospheric pressure of 1.5 atmospheres for 60 minutes on chronic mild traumatic brain injury with a wait time of at least 6 months or more after the traumatic brain injury occurred in the U.S. Veterans.

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: October 30, 2024
• Study Start: September 7, 2021
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: August 26, 2025

Record last verified: 2025-08

Locations

US (1)