Trial · NCT06665633
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 29
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | Beck Anxiety Inventory | pre- HBOT and 1, 6. 12 months after HBOT | The Beck Anxiety Inventory (BAI) is a validated 21-item self-report questionnaire used to assess the severity of anxiety symptoms. Higher scores indicate more severe symptoms. A score of 0-7 indicates minimal anxiety, 8-15 mild anxiety, 16-25 moderate anxiety, and 26-63 severe anxiety. |
| Secondary | Beck Depression Inventory II | pre- HBOT and 1, 6. 12 months after HBOT | The Beck Depression Inventory is a validated self-report questionnaire that indicates the severity of depressive symptoms. Scores are typically categorized as minimal (0-13), mild (14-19), moderate (20-28), or severe (29-63) depression, with higher scores indicating more pronounced symptoms. |
| Secondary | Brief Pain Inventory | pre- HBOT and 1, 6. 12 months after HBOT | It is a validated self-report questionnaire used to assess pain in patients. It measures the intensity of pain (severity) and how it interferes with daily activities (interference). It is scored by calculating the mean of the items for pain severity and pain interference, each on a scale of 0-10. The higher the score, the more intense the pain and the more it interferes with daily activities. |
| Secondary | Traumatic Brain Injury Screening Tool | pre- HBOT | Criteria for Mild Traumatic Brain Injury: * Confused/disoriented state that lasts less than 24 hours * Loss of consciousness for up to 30 minutes * Memory loss lasting less than 24 hours * Excluded severe TBI with skull penetrating injury, brain hemorrhage Other cognitive difficulties include feeling dazed, groping for words, and having problems with attention, concentration, processing speed, planning, reasoning, and abstract thinking. Physical symptoms include headache, nausea, vomiting, drowsiness, fatigue, dizziness, loss of balance, blurred vision, unrefreshed sleep, sensitivity to light or sound, tinnitus, and alteration of taste or smell. Some patients also experience mental health symptoms including anxiety, depression, post-traumatic stress disorder, and suicide ideation |
| Secondary | Davidson Trauma Scale | pre- HBOT and 1, 6. 12 months after HBOT | It is a validated 17-item self-report questionnaire used to assess the severity of post-traumatic stress disorder (PTSD) symptoms. The total score, which can range from 0 to 136. Higher scores indicate more severe PTSD symptoms. |
| Secondary | 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. |
| Secondary | Pittsburgh Sleep Quality Index | pre- HBOT and 1, 6. 12 months after HBOT | It is a validated self-report questionnaire that assesses sleep quality over a one-month time interval. The sum of these component scores yields a global PSQI score, ranging from 0 to 21, with higher scores indicating poorer sleep quality. A global PSQI score greater than 5 is generally considered indicative of poor sleep quality. |
| Secondary | The Quick Environmental Exposure and Sensitivity Inventory (QEESI) | pre- HBOT and 1, 6. 12 months after HBOT | It is a validated self-report questionnaire that helps researchers, doctors, and their patients identify individuals with multiple chemical intolerances and their responses to the chemicals. The score is 0-10 with the higher score indicating a worse response to chemical exposures. |
| Secondary | Short-Form 36 Health Survey | pre- HBOT and 1, 6. 12 months after HBOT | It is a validated questionnaire used to measure health-related quality of life. It has eight scaled scores, each ranging from 0 to 100, with lower scores indicating more disability and higher scores indicating less disability. The eight scales are physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. All cytokines were measured in picograms/milliliter and measured in the Multiplex Cytokine Analyzer. All of the individual cytokines were compared to normal, high, and low controls. |
| Secondary | PTSD Checklist - Stressor Specific Version (PCL-S) | pre- HBOT and 1 month after HBOT | The PCL is a validated 17-item self-report measure of the DSM-IV symptoms of PTSD. Respondents rate how much they were "bothered by a symptom" on a 5-point scale ranging from 1 ("not at all") to 5 ("extremely"). A higher score indicates the more severe outcome. A score between 31 and 33 is often used as a cut-off score to indicate probable PTSD with 80 the maximum score. |
| Secondary | Clinical Criteria for Traumatic Brain Injury Severity | pre- HBOT and 1 month after HBOT | Clinical Criteria: Mild, Moderate, Severe. Structural Imaging: Normal, Normal or abnormal, Normal or Abnormal. Loss of Consciousness: \< 30 minutes, 30 minutes to 24 hours, \> 24 hours. Alteration of Consciousness/Mental State: A moment to 24 hrs. \> 24 hours \> 24 hours. Post-traumatic Amnesia: 0-1 day, \> 1 and \< 7 days, \> 7 days. |
| Secondary | 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. |
| Secondary | 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. . |
| Secondary | Neurocognitive Index | pre- HBOT and 1, 6. 12 months after HBOT | It is the average of five domain scores: Composite Memory, Psychomotor Speed, Reaction Time, Complex Attention , and Cognitive Flexibility ; representing a form of a global score of neurocognition. Scores range from less than 70, very low, to greater than 109, above average. |
| Secondary | Composite Memory | pre- HBOT and 1, 6. 12 months after HBOT | Questionnaire measures the ability to recognize, remember, and retrieve words and geometric figures. Scores range from less than 70, very low, to greater than 109, above average. |
| Secondary | Verbal Memory | pre- HBOT and 1, 6. 12 months after HBOT | Questionnaire measures the ability to recognize, remember, and retrieve words. Scores range from less than 70, very low, to greater than 109, above average. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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