Hyperbaric Oxygen for Post Concussive Syndrome

Study Overview
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Brief Summary
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We would like to see if Hyperbaric Oxygen can help improve the symptoms that result from Post Concussive Syndrome.

Detailed Description
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Purpose: The purpose of this study is to examine the role of Hyperbaric Oxygen Therapy (HBOT) in decreasing symptoms in patients with a diagnosis of chronic post concussive syndrome (PCS). Hypothesis: The study hypothesis is that HBOT will decrease symptoms measured by standard measurement tools when provided to patients who have a diagnosis of PCS and are 6 months to 36 months post injury. Study Overview: Hyperbaric oxygen therapy (HBOT) involves the administration of inhaled 100% oxygen at increased ambient pressure inside a closed vessel. HBOT produces greatly elevated arterial and tissue oxygen tensions, producing a wide variety of physiological effects at the cellular and sub cellular level. Participants will be selected from the post-concussive syndrome population based on an expectation that they would experience a clinically significant improvement. Eligible subjects will be experiencing post concussive symptoms related to an injury within the last 6 to 36 months. The study will be enrolling 150 participants and will be randomized to two different treatment arms: experimental group and a waitlist group. Each participant will receive a series of forty 2 hour treatments, delivered once a day, 5 days a week, within the hyperbaric oxygen chamber.There will be assessments completed before treatment series begins, at the end of treatment, 8 months and 14 months after treatment begins. The primary outcome will be administered at these times as well as every two weeks once treatment begins until the end of the study.

Official Title
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Hyperbaric Oxygen for Post Concussive Syndrome

Conditions
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Post-Concussion Syndrome

Intervention / Treatment
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* Other: Hyperbaric Oxygen Therapy
* Other: Waitlist Hyperbaric Oxygen Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to speak English and give informed consent. A diagnosis of chronic PCS made by a referring physician Time of injury between 6 and 36 months previously Able to sit in the chamber for 120 minutes. Exclusion Criteria: Untreated collapsed lung (pneumothorax) Have taken the chemotherapy drug Doxorubicin within 72 hours Have taken the chemotherapy drug Bleomycin within 4 months Bowel obstruction Heart pacemaker that has not been certified as safe for exposure to 2.0 ATA Pregnancy Severe Chronic Obstructive Pulmonary Disease (COPD) Participation in other PCS related studies. Previous recent HBOT Previous recent deep sea diving experience

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate Treatment<br>This arm will receive hyperbaric oxygen therapy once consented. | Other: Hyperbaric Oxygen Therapy<br>* 100% oxygen delivered by hood at 2 ATA for 90 minutes with 5 minute air breaks<br>|
| Experimental: Waitlist - to be treated<br>This arm will receive a hyperbaric oxygen therapy after waiting two months. | Other: Waitlist Hyperbaric Oxygen Therapy<br>* 100% oxygen delivered by hood at 2 ATA for 90 minutes with 5 minute air breaks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Rivermead Post Concussion Syndrome Questionnaire | 15 questions regarding a participant's Post Concussive symptoms | Baseline, after 10, 20, 30 hyperbaric treatments, 2, 2.5, 3, 3.5, 4,4.5, 5, 5.5 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 13.5 and 14 months post baseline, | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the NIH Tool Box | Cognitive Assessment Cluster | Baseline, 2 months post baseline, 8 months post baseline, 14 months post baseline | 
| Change in the Patient Health Questionnaire (PHQ-9) | Depression Assessment | Baseline, 2 months post baseline, 8 months post baseline, 14 months post baseline | 
| Change in the Short Form Health Survey (SF-36) | Quality of Life Assessment | Baseline, 2 months post baseline, 8 months post baseline, 14 months post baseline | 
| Change in the Quality of Life After Brain Injury (QOLIBRI) | Quality of Life Assessment | Baseline, 2 months post baseline, 8 months post baseline, 14 months post baseline | 
| Change in the WHO Disability Assessment Schedule (WHODAS 2.0) | Daily Functioning Assessment | Baseline, 2 months post baseline, 8 months post baseline, 14 months post baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyperbaric oxygen, Pressurized oxygen, Concussion, Post concussive syndrome, Oxygen therapy