Treatment of U.S. Veterans With Mild Traumatic Brain Injury With Hyperbaric Oxygen Therapy
Overview
- Phase
- Phase 1
- Intervention
- Oxygen 100 % Gas for Inhalation
- Conditions
- Mild Traumatic Brain Injury
- Sponsor
- Nova Southeastern University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Brain SPECT Scan
- Status
- Completed
- Last Updated
- 8 months ago
Overview
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.
Investigators
Alison Bested
Alison C. Bested MD, FRCPC. Associate Professor, Chair Hyperbaric Medicine, Nova Southeastern University
Nova Southeastern University
Eligibility Criteria
Inclusion Criteria
- •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.
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:
- •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)
Arms & Interventions
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.
Intervention: Oxygen 100 % Gas for Inhalation
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.
Intervention: Hyperbaric Oxygen Therapy Chamber
Outcomes
Primary Outcomes
Brain SPECT Scan
Time Frame: pre- HBOT and 4 weeks after HBOT
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.
Secondary Outcomes
- 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)
- Functional Capacity Scale(pre- HBOT and 1, 6. 12 months after HBOT)
- The Quick Environmental Exposure and Sensitivity Inventory (QEESI)(pre- HBOT and 1, 6. 12 months after HBOT)
- Composite Memory(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)
- Pittsburgh Sleep Quality Index(pre- HBOT and 1, 6. 12 months after HBOT)
- Short-Form 36 Health Survey(pre- HBOT and 1, 6. 12 months after HBOT)
- Quantitative Electroencephalography(pre- HBOT and 1 month after HBOT)
- Overnight Sleep Study(pre- HBOT and 1 month after HBOT)
- Measure Blood Markers of Inflammation(pre- HBOT and 1 month after HBOT)
- PTSD Checklist - Stressor Specific Version (PCL-S)(pre- HBOT and 1 month after HBOT)
- Clinical Criteria for Traumatic Brain Injury Severity(pre- HBOT and 1 month after HBOT)
- Mitochondrial Function(pre- HBOT and 1 month after HBOT)
- Measure DNA Repair(pre- HBOT and 1 month after HBOT)
- Neurocognitive Index(pre- HBOT and 1, 6. 12 months after HBOT)
- Verbal Memory(pre- HBOT and 1, 6. 12 months after HBOT)
- Visual Memory(pre- HBOT and 1, 6. 12 months after HBOT)
- Finger Tapping(pre- HBOT and 1, 6. 12 months after HBOT)
- Symbol Digit Coding(pre- HBOT and 1, 6. 12 months after HBOT)
- Stroop Test(pre- HBOT and 1, 6. 12 months after HBOT)
- Shifting Attention(pre- HBOT and 1, 6. 12 months after HBOT)
- Continuous Performance(pre- HBOT and 1, 6. 12 months after HBOT)
- Perception of Emotions(pre- HBOT and 1, 6. 12 months after HBOT)
- Non-Verbal Reasoning(pre- HBOT and 1, 6. 12 months after HBOT)
- 4-Part Continuous Performance(pre- HBOT and 1, 6. 12 months after HBOT)