Treatment of U.S. Veterans With Mild Traumatic Brain Injury With Hyperbaric Oxygen Therapy
Completed · Phase 1
Conditions studied: Mild Traumatic Brain Injury, Hyperbaric Oxygen Therapy, Depression
In brief
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).
Key facts
- Study ID
- NCT06665633
- Run by
- Nova Southeastern University
- People needed
- 40
- Starts
- 2021-09-07
- Expected to finish
- 2025-07-01
- Last updated by the study team
- 2025-08-26
Who can join
Age: 18 and older, up to 70. Sex: male. Healthy volunteers: not accepted.
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
- Currently have no exclusionary diagnoses that could reasonably explain the symptoms of their fatiguing illness and their severity, using the exclusion criteria best described in case definition paper for Chronic Fatigue Syndrome (CFS), as described in detail in Reeves, et all 2003, which clarifies exclusionary conditions.
- History of moderate to severe traumatic brain injury or TBI requiring hospitalization in the past five years.
- 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)
- 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.
Where it is running
- Nova Southeastern University — Fort Lauderdale, Florida, United States
Full record on ClinicalTrials.gov
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