Clinical trial NCT06665633: Treatment of U.S. Veterans with Mild Traumatic Brain Injury with Hyperbaric Oxygen Therapy
Official title: Treatment of U.S. Veterans with Mild Traumatic Brain Injury with Hyperbaric Oxygen Therapy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Mild Traumatic Brain Injury
Hyperbaric Oxygen Therapy
Depression
Keywords: Mild Traumatic Brain Injury
Hyperbaric Oxygen Therapy
Brain SPECT Scan
Brodmann Areas
Suicide
Depression
Lead sponsor: Nova Southeastern University
Sponsor class: OTHER
First posted: 2024-10-30
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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
13. 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.
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.

Primary outcomes:
measure: Brain SPECT Scan
timeFrame: pre- HBOT and 4 weeks after HBOT
Secondary outcomes:
measure: Zung Anxiety Inventory
timeFrame: pre- HBOT and 1, 6. 12 months after HBOT
measure: Zung Depression Inventory II
timeFrame: pre- HBOT and 1, 6. 12 months after HBOT
measure: Brief Pain Inventory
timeFrame: pre- HBOT and 1, 6. 12 months after HBOT
measure: Criteria for Traumatic Brain Injury Severity
timeFrame: pre- HBOT and 1, 6. 12 months after HBOT
measure: Davidson Trauma Scale
timeFrame: pre- HBOT and 1, 6. 12 months after HBOT
measure: Functional Capacity Scale
timeFrame: pre- HBOT and 1, 6. 12 months after HBOT
measure: Pittsburgh Sleep Quality Index
timeFrame: pre- HBOT and 1, 6. 12 months after HBOT
measure: The Quick Environmental Exposure and Sensitivity Inventory (QEESI)
timeFrame: pre- HBOT and 1, 6. 12 months after HBOT
measure: Short-Form 36 Health Survey
timeFrame: pre- HBOT and 1, 6. 12 months after HBOT
measure: Quantitative Electroencephalography
timeFrame: pre- HBOT and 1 month after HBOT
measure: Overnight Sleep Study
timeFrame: pre- HBOT and 1 month after HBOT
measure: Measure Blood Markers of Inflammation
timeFrame: pre- HBOT and 1 month after HBOT
measure: PTSD Checklist - Stressor Specific Version (PCL-S)
timeFrame: pre- HBOT and 1 month after HBOT
measure: Head Injury Questionnaire Disability Scale
timeFrame: pre- HBOT and 1 month after HBOT
measure: Mitochondrial Function
timeFrame: pre- HBOT and 1 month after HBOT
measure: Measure DNA Repair
timeFrame: pre- HBOT and 1 month after HBOT
measure: Neurocognitive Index
timeFrame: pre- HBOT and 1, 6. 12 months after HBOT
measure: Composite Memory
timeFrame: pre- HBOT and 1, 6. 12 months after HBOT
measure: Verbal Memory
timeFrame: pre- HBOT and 1, 6. 12 months after HBOT
measure: Visual Memory
timeFrame: pre- HBOT and 1, 6. 12 months after HBOT
measure: Finger Tapping
timeFrame: pre- HBOT and 1, 6. 12 months after HBOT
measure: Symbol Digit Coding
timeFrame: pre- HBOT and 1, 6. 12 months after HBOT
measure: Stroop Test
timeFrame: pre- HBOT and 1, 6. 12 months after HBOT
measure: Shifting Attention
timeFrame: pre- HBOT and 1, 6. 12 months after HBOT
measure: Continuous Performance
timeFrame: pre- HBOT and 1, 6. 12 months after HBOT
measure: Perception of Emotions
timeFrame: pre- HBOT and 1, 6. 12 months after HBOT
measure: Non-Verbal Reasoning
timeFrame: pre- HBOT and 1, 6. 12 months after HBOT
measure: 4-Part Continuous Performance
timeFrame: pre- HBOT and 1, 6. 12 months after HBOT
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
facility: Nova Southeastern University
state: Florida
Study officials:
affiliation: Nova Southeastern University
name: Alison C Bested, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References: