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The purpose of this study is to decrease symptom burden, improve cognitive function, and improve quality of life outcomes in subjects with mild TBI and persisting post-concussion syndrome using Hyperbaric Oxygen Treatment compared to a sham intervention.
Specific Aims:
Evaluate the efficacy of hyperbaric oxygen treatment to improve outcomes for adults with persisting post-concussion syndrome. Specifically, the investigators hypothesize that a prescribed course of hyperbaric oxygen treatments (HBOT) will improve outcomes and quality of life in adults with persisting symptoms >3 months after injury.
Assess the safety and tolerability of hyperbaric oxygen treatments and compliance with treatment in adults with persisting post-concussion syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HBOT Arm | Experimental | Pressurized at 2.0 atmospheres absolute of pressure (ATA) Breathe 100% oxygen 90 minute session, 5 days per week, for 20 sessions |
|
| Control Arm | Sham Comparator | Placebo Gas Pressurized at 2.0 ATA Breathe placebo gas system of 10.5% oxygen and 89.5% nitrogen to mimic the partial pressure of oxygen breathed in regular air at sea level pressure 90 minute session, 5 days per week, for 20 sessions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperbaric Oxygen Treatment | Device | Pressurization at 2.0 ATA with 100% oxygen |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in symptom burden as measured by the Rivermead Post-Concussion Symptoms Questionnaire-3 (RPQ-3) | Change in symptom burden is measured by the Rivermead Post-Concussion Symptoms Questionnaire-3 (RPQ-3) which is a 16 item questionnaire of common cognitive, behavioral, and physical symptoms experienced following a mTBI. The RPQ is rated on a 0-4 scale with scores ranging from 0-64. Higher levels of endorsement indicate more severe symptoms. The RPQ-3 is the total score of the first three items of the RPQ and includes "headaches," "feelings of dizziness," and "nausea and/or vomiting." | Baseline, immediately after treatment |
| Change in symptom burden as measured by the Rivermead Post-Concussion Symptoms Questionnaire-3 (RPQ-3) | Change in symptom burden is measured by the Rivermead Post-Concussion Symptoms Questionnaire-3 (RPQ-3) which is a 16 item questionnaire of common cognitive, behavioral, and physical symptoms experienced following a mTBI. The RPQ is rated on a 0-4 scale with scores ranging from 0-64. Higher levels of endorsement indicate more severe symptoms. The RPQ-3 is the total score of the first three items of the RPQ and includes "headaches," "feelings of dizziness," and "nausea and/or vomiting." | Baseline, 1 month after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in symptom burden as measured by the Rivermead Post-Concussion Symptoms Questionnaire-13 (RPQ-13) | Change in symptom burden is measured by the Rivermead Post-Concussion Symptoms Questionnaire (RPQ) which is a 16 item questionnaire of common cognitive, behavioral, and physical symptoms experienced following a mTBI. The RPQ is rated on a 0-4 scale with scores ranging from 0-64. Higher levels of endorsement indicate more severe symptoms. The RPQ-3 is the total score of the first three items of the RPQ and includes "headaches," "feelings of dizziness," and "nausea and/or vomiting." The RPQ-13 is the total score of the remaining 13 items on the RPQ scale. |
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Inclusion Criteria:
Exclusion Criteria:
Clinically significant cardiac, neurological, psychological/psychiatric, or respiratory impairment in the opinion of the investigators, including but not limited to:
Pulmonary:
Cardiac:
Hematological/Oncological:
Neurological and Psychological:
Head and Neck:
Miscellaneous:
Relative exclusion criteria: Diagnosis of the conditions listed below will require approval of the hyperbaric medicine physician for enrollment into the study.
Medications: Individuals with recent (within the past six months) or concurrent use of these medications must be approved by the hyperbaric medicine physician.
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| Name | Affiliation | Role |
|---|---|---|
| James Berry, M.D. | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Exercise and Environmental Medicine/University of Texas Southwestern Medical Center | Dallas | Texas | 75231 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 12, 2026 | Jun 8, 2026 | 7 | ||
| Jun 30, 2026 |
| ID | Term |
|---|---|
| D038223 | Post-Concussion Syndrome |
| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| D016489 | Head Injuries, Closed |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
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Participants will be randomized between HBOT and control group with a 1:1 allocation ratio, stratified by decade of age and gender via computer generated block randomization with block size of four.
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| Placebo gas |
| Other |
Pressurization at 2.0 ATA with 10.5% oxygen to mimic normal air |
|
| Baseline, immediately after last treatment |
| Change in symptom burden as measured by the Rivermead Post-Concussion Symptoms Questionnaire-13 (RPQ-13) | Change in symptom burden is measured by the Rivermead Post-Concussion Symptoms Questionnaire (RPQ) which is a 16 item questionnaire of common cognitive, behavioral, and physical symptoms experienced following a mTBI. The RPQ is rated on a 0-4 scale with scores ranging from 0-64. Higher levels of endorsement indicate more severe symptoms. The RPQ-3 is the total score of the first three items of the RPQ and includes "headaches," "feelings of dizziness," and "nausea and/or vomiting." The RPQ-13 is the total score of the remaining 13 items on the RPQ scale. | Baseline, 1 month after treatment |
| Change in quality of life as measured by the Short Form Survey (SF-36) | Change in quality of life is measured by the Short Form Survey (SF-36) which consists of 36 items and measures quality of life via eight different domains including vitality, physical functioning, social functioning, emotional role, physical role, general health, social functioning, and mental health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The higher scores indicating better levels of function and/or better health. A positive change from Baseline indicates improvement. | Baseline, immediately after treatment |
| Change in quality of life as measured by the Short Form Survey (SF-36) | Change in quality of life is measured by the Short Form Survey (SF-36) which consists of 36 items and measures quality of life via eight different domains including vitality, physical functioning, social functioning, emotional role, physical role, general health, social functioning, and mental health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The higher scores indicating better levels of function and/or better health. A positive change from Baseline indicates improvement. | Baseline, 1 month |
| Global Impression of Change (GIC) | The Global Impression of Change scale is a seven-point scale in which participants are asked to rate how much the treatment has changed their activity limitations, symptoms, emotions, and overall quality of life. Possible scores range from -3 (very much worse) to +3 (very much better) with 0 being no change. | Baseline, after 5 treatment sessions (approximately 1 week after starting treatment) |
| Global Impression of Change (GIC) | The Global Impression of Change scale is a seven-point scale in which participants are asked to rate how much the treatment has changed their activity limitations, symptoms, emotions, and overall quality of life. Possible scores range from -3 (very much worse) to +3 (very much better) with 0 being no change. | Baseline, after 10 treatment sessions (approximately 2 weeks after starting treatment) |
| Global Impression of Change (GIC) | The Global Impression of Change scale is a seven-point scale in which participants are asked to rate how much the treatment has changed their activity limitations, symptoms, emotions, and overall quality of life. Possible scores range from -3 (very much worse) to +3 (very much better) with 0 being no change. | Baseline, after 15 treatment sessions (approximately 3 weeks after starting treatment) |
| Global Impression of Change (GIC) | The Global Impression of Change scale is a seven-point scale in which participants are asked to rate how much the treatment has changed their activity limitations, symptoms, emotions, and overall quality of life. Possible scores range from -3 (very much worse) to +3 (very much better) with 0 being no change. | Baseline, after 20 treatment sessions (approximately 3 weeks after starting treatment) |
| Global Impression of Change (GIC) | The Global Impression of Change scale is a seven-point scale in which participants are asked to rate how much the treatment has changed their activity limitations, symptoms, emotions, and overall quality of life. Possible scores range from -3 (very much worse) to +3 (very much better) with 0 being no change. | Baseline, 1 month post-treatment |
| Percentage of participant feeling of back to normal, pre-injury self at baseline as assessed based on patient rating | Percentage of participant feeling of back to normal, pre-injury self at baseline is assessed based on patient rating. Participants will be asked to rate what percent they feel back to their normal, pre-injury self at baseline | Baseline |
| Percent change in participant feeling of back to normal, pre-injury self as assessed based on patient rating | Percent change in participant feeling of back to normal, pre-injury self is assessed based on patient rating. Participants will be asked to rate what percent they feel back to their normal, pre-injury self at baseline | Baseline, after 5 treatment sessions (approximately 1 week after starting treatment) |
| Percent change in participant feeling of back to normal, pre-injury self as assessed based on patient rating. | Percent change in participant feeling of back to normal, pre-injury self is assessed based on patient rating. Participants will be asked to rate what percent they feel back to their normal, pre-injury self at baseline | Baseline, after 10 treatment sessions (approximately 2 weeks after starting treatment) |
| Percent change in participant feeling of back to normal, pre-injury self as assessed based on patient rating | Percent change in participant feeling of back to normal, pre-injury self is assessed based on patient rating. Participants will be asked to rate what percent they feel back to their normal, pre-injury self at baseline | Baseline, after 15 treatment sessions (approximately 3 weeks after starting treatment) |
| Percent change in participant feeling of back to normal, pre-injury self as assessed based on patient rating | Percent change in participant feeling of back to normal, pre-injury self is assessed based on patient rating. Participants will be asked to rate what percent they feel back to their normal, pre-injury self at baseline | Baseline, after 20 treatment sessions (approximately 4 weeks after starting treatment) |
| Percent change in participant feeling of back to normal, pre-injury self as assessed based on patient rating | Percent change in participant feeling of back to normal, pre-injury self is assessed based on patient rating. Participants will be asked to rate what percent they feel back to their normal, pre-injury self at baseline | Baseline, 1 month post-treatment |
| Change in psychological/mood symptoms as measured by Brief Symptom Inventory (BSI) scale | Change in psychological/mood symptoms is measured by Brief Symptom Inventory (BSI) scale. The Brief Symptom Inventory (BSI) (secondary outcome): contains 18 items with 3 subscales measuring Depression, Anxiety, and Somatization and total raw score represents the Global Severity Index (GSI). Scores on each of the 3 subscales range from 0-24 and total GSI scores range from 0-72. Higher scores on the subscales and total GSI are indicative of more severe psychological/mood symptoms | Baseline, immediately after last treatment |
| Change in psychological/mood symptoms as measured by Brief Symptom Inventory (BSI) scale | Change in psychological/mood symptoms is measured by Brief Symptom Inventory (BSI) scale. The Brief Symptom Inventory (BSI) (secondary outcome): contains 18 items with 3 subscales measuring Depression, Anxiety, and Somatization and total raw score represents the Global Severity Index (GSI). Scores on each of the 3 subscales range from 0-24 and total GSI scores range from 0-72. Higher scores on the subscales and total GSI are indicative of more severe psychological/mood symptoms | Baseline, 1 month after treatment |
| Number of participants with adverse events | Safety (Tolerability) of the treatment is assessed by monitoring and evaluating Adverse events (AE)s by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for 30 days post-treatment | 1 month after treatment |
| Number of participants who missed the treatment | The count of participants who missed the treatment is assessed. | 5 weeks |
| D009422 |
| Nervous System Diseases |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |