Treatment of U.S. Veterans with Mild Traumatic Brain Injury with Hyperbaric Oxygen Therapy
- Conditions
- Mild Traumatic Brain InjuryHyperbaric Oxygen TherapyDepression
- Interventions
- Device: Hyperbaric Oxygen Therapy Chamber
- Registration Number
- NCT06665633
- Lead Sponsor
- Nova Southeastern University
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 40
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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.
An individual is ineligible to participate if does not meet the criteria for mild traumatic brain injury and if any of the following apply:
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Female gender due to small pilot study and hormonal changes in women.
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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
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Current heavy use of alcohol or tobacco use (self-report in last 6 months)
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Current organ failure (as determined by self-report)
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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
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Chronic active infections such as HIV, hepatitis B, and hepatitis C (self-report)
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History of organ transplant (self-report)
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Current primary sleep disorders such as insomnia, sleep related breathing disorders, etc.
(self-report)
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Any allergic disease (self-report) such as allergic asthma
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Use of medications that could affect immune function (e.g., steroids, immunosuppressants) (self-report)
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Renal insufficiency
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Hepatic insufficiency
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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.
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History of moderate to severe traumatic brain injury or TBI requiring hospitalization in the past five years.
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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)
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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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment of U.S. Veterans with mild traumatic brain injury with hyperbaric oxygen therapy Oxygen 100 % Gas for Inhalation 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. Treatment of U.S. Veterans with mild traumatic brain injury with hyperbaric oxygen therapy Hyperbaric Oxygen Therapy Chamber 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.
- Primary Outcome Measures
Name Time Method Brain SPECT Scan 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 Outcome Measures
Name Time Method Zung Anxiety Inventory pre- HBOT and 1, 6. 12 months after HBOT Self-report questionnaire used to assess anxiety levels.
Zung Depression Inventory II pre- HBOT and 1, 6. 12 months after HBOT Self-report questionnaire used to assess the severity of depression.
Brief Pain Inventory pre- HBOT and 1, 6. 12 months after HBOT Medical questionnaire used to measure pain
Criteria for Traumatic Brain Injury Severity pre- HBOT and 1, 6. 12 months after HBOT Questionnaire used to measure the severity of traumatic brain injury.
Davidson Trauma Scale pre- HBOT and 1, 6. 12 months after HBOT Questionnaire used to measure the symptoms of Post Traumatic Stress Disorder
Functional Capacity Scale pre- HBOT and 1, 6. 12 months after HBOT Self-report scale from 0 to 10 to measure the severity of fatigue and cognitive ability. Better energy and cognitive function is reflected in a higher number.
Pittsburgh Sleep Quality Index pre- HBOT and 1, 6. 12 months after HBOT Questionnaire to evaluate sleep quality.
The Quick Environmental Exposure and Sensitivity Inventory (QEESI) pre- HBOT and 1, 6. 12 months after HBOT Chemical intolerance self-assessment.
Short-Form 36 Health Survey pre- HBOT and 1, 6. 12 months after HBOT Self-report questionnaire to measure health.
Quantitative Electroencephalography pre- HBOT and 1 month after HBOT It measures the electrical activity in the form of brain wave patterns of the brain. It is called brain mapping and measures quantitative metrics related to cognitive brain functions. It quantitatively measures the delta, theta, alpha and beta bands.
Overnight Sleep Study pre- HBOT and 1 month after HBOT The Cerebra software system is used at home and measures the sleep for one night and includes measuring the percentage of oxygen saturation in the blood as % oxygen using a pulse oximeter, measures heart rate in beats per minute on ECG, breathing rate - measures breathes per minute, limb movement - records leg movement per hour, measures total minutes of time spent snoring, measures the sleep position - in minutes of time spent on back or sides, and measures amount of minutes on EEG brain waves in the different sleep stages including: non-rapid eye movement (NREM) sleep, rapid eye movement (REM) sleep, and stages III/IV sleep. A final report summarizes the sleep study findings.
Measure Blood Markers of Inflammation pre- HBOT and 1 month after HBOT Measure 18 blood cytokines using Q-Plex Array. Measures levels of Tumor Necrosis Factor-1, Interleukin-1a,Interleukin-1b, Interleukin-2, Interleukin-4, Interleukin-5, Interleukin-6,Interleukin -8, Interferon gamma, Interleukin12p70, Interleukin-13, Interleukin-23, Interleukin-15, Interleukin-17, Interleukin-10, Tumor Necrosis Factor alpha, Tumor Necrosis Factor-Receptor II, Tumor Necrosis Factor beta
PTSD Checklist - Stressor Specific Version (PCL-S) pre- HBOT and 1 month after HBOT Measure PTSD symptoms and severity
Head Injury Questionnaire Disability Scale pre- HBOT and 1 month after HBOT Symptom severity of head injury
Mitochondrial Function pre- HBOT and 1 month after HBOT Mitochondrial function is measured in the peripheral blood mononuclear cells (PBMCs) using the Seahorse™ Assay. The PBMCs reflect functioning of the brain's neurons and will assess if there is mitochondrial repair after hyperbaric oxygen therapy.
Measure DNA Repair pre- HBOT and 1 month after HBOT DNA repair measured by measuring Nucleotide Excision Repair in peripheral blood mononuclear cells (PBMCs), which is a reflection of what is occurring in the brain's neurons and will assess if there is DNA repair after hyperbaric oxygen therapy. .
Neurocognitive Index pre- HBOT and 1, 6. 12 months after HBOT Questionnaire with quantitative assessment of the overall neurocognitive status.
Composite Memory pre- HBOT and 1, 6. 12 months after HBOT Questionnaire measures the ability to recognize, remember, and retrieve words and geometric figures.
Verbal Memory pre- HBOT and 1, 6. 12 months after HBOT Questionnaire measures the ability to recognize, remember, and retrieve words.
Visual Memory pre- HBOT and 1, 6. 12 months after HBOT Questionnaire measures the recognition memory for abstract figures or shapes.
Finger Tapping pre- HBOT and 1, 6. 12 months after HBOT Online computer test process that measures motor speed and fine motor control.
Symbol Digit Coding pre- HBOT and 1, 6. 12 months after HBOT Online computer test process that measures complex information, processing accuracy, complex attention, visual-perceptual speed, and information processing speed.
Stroop Test pre- HBOT and 1, 6. 12 months after HBOT Online computer test process that measures simple reaction time, complex reaction time, Stroop reaction time, inhibition/disinhibition, and frontal or executive skills.
Shifting Attention pre- HBOT and 1, 6. 12 months after HBOT Online computer test process that measures the ability to shift from one instruction set to another quickly and accurately.
Continuous Performance pre- HBOT and 1, 6. 12 months after HBOT Online computer test process that measures vigilance or sustained attention or attention over time
Perception of Emotions pre- HBOT and 1, 6. 12 months after HBOT Questionnaire measures how well a subject can perceive and identify specific emotions.
Non-Verbal Reasoning pre- HBOT and 1, 6. 12 months after HBOT Questionnaire measures how well a subject can perceive and understand the meaning of visual or abstract information and recognizing relationships between visual-abstract concepts.
4-Part Continuous Performance pre- HBOT and 1, 6. 12 months after HBOT It is a four-part online computer test that measures a subject's working memory and sustained attention.
Trial Locations
- Locations (1)
Nova Southeastern University
🇺🇸Fort Lauderdale, Florida, United States