Post-Concussion Syndrome
Conditions
Brief summary
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: 1. 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. 1. Decrease symptom burden as measured by the Rivermead Post-Concussion Symptoms Questionnaire (RPQ). 2. Improve cognitive function as measured by the National Institutes of Health (NIH) Toolbox Cognition Battery. 3. Improve quality of life as measured by the 36-Item Short Form Survey (SF-36). 2. Assess the safety and tolerability of hyperbaric oxygen treatments and compliance with treatment in adults with persisting post-concussion syndrome.
Interventions
Pressurization at 2.0 ATA with 100% oxygen
OTHERPlacebo gas
Pressurization at 2.0 ATA with 10.5% oxygen to mimic normal air
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Must have been evaluated within 3 weeks of injury and given a diagnosis of concussion by a medical professional * Must be experiencing persistent symptoms 3-12 months after injury as defined as having at least symptoms that are moderate to severe (score 3-4) OR at least a total score of 10 with at least 1 symptom rated moderate to severe (3-4) on the Rivermead Post-Concussion Questionnaire (RPQ).
Exclusion criteria
Clinically significant cardiac, neurological, psychological/psychiatric, or respiratory impairment in the opinion of the investigators, including but not limited to: 1. Pulmonary: * COPD with CO2 retention; previous/current imaging showing hyperinflation/air trapping/bullous disease/blebs * Current pneumothorax or previous spontaneous pneumothorax 2. Cardiac: * Uncontrolled HTN (systolic \>180 or diastolic \>100) * Known Ejection fraction \< 35% * Pacemaker / ICD in place (not approved for chamber use) 3. Hematological/Oncological: * Current chemotherapeutic drug use, and past history of bleomycin use. * Hereditary Spherocytosis * Sickle cell anemia 4. Neurological and Psychological: * Implanted nerve stimulators * Uncontrolled seizure disorder * Drug or alcohol abuse/dependence * Current treatment for alcohol cessation with disulfiram * Claustrophobia 5. Head and Neck: * Inability to equilibrate the pressure of middle ears and sinuses * Current or previous retinal detachment * Retinal or vitreous surgery within the past 3 months 6. Miscellaneous: * Current fever or active infection * Implanted devices not on the approved list for use with HBOT * Women who are pregnant. Women with childbearing potential are required to use effective birth control if not surgically sterile or postmenopausal for \>2 years. * Undergoing vestibular or other therapy during the intervention * Planning a change in medication during the intervention 7. Relative
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in symptom burden as measured by the Rivermead Post-Concussion Symptoms Questionnaire-3 (RPQ-3) | Baseline, immediately after treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in quality of life as measured by the Short Form Survey (SF-36) | Baseline, immediately after treatment | 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. |
| Global Impression of Change (GIC) | Baseline, after 5 treatment sessions (approximately 1 week after starting treatment) | 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. |
| Percentage of participant feeling of back to normal, pre-injury self at baseline as assessed based on patient rating | Baseline | 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 |
| Percent change in participant feeling of back to normal, pre-injury self as assessed based on patient rating | Baseline, after 5 treatment sessions (approximately 1 week after starting treatment) | 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 |
| Change in symptom burden as measured by the Rivermead Post-Concussion Symptoms Questionnaire-13 (RPQ-13) | Baseline, immediately after last treatment | 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. |
| Change in psychological/mood symptoms as measured by Brief Symptom Inventory (BSI) scale | Baseline, immediately after last treatment | 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 |
| Number of participants with adverse events | 1 month after treatment | 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 |
| Number of participants who missed the treatment | 5 weeks | The count of participants who missed the treatment is assessed. |
| Percent change in participant feeling of back to normal, pre-injury self as assessed based on patient rating. | Baseline, after 10 treatment sessions (approximately 2 weeks after starting treatment) | 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 |
Countries
United States
Outcome results
None listed