Post-Concussion Syndrome
Conditions
Keywords
Hyperbaric oxygen, Pressurized oxygen, Concussion, Post concussive syndrome, Oxygen therapy
Brief summary
We would like to see if Hyperbaric Oxygen can help improve the symptoms that result from Post Concussive Syndrome.
Detailed description
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.
Interventions
OTHERHyperbaric Oxygen Therapy
100% oxygen delivered by hood at 2 ATA for 90 minutes with 5 minute air breaks
OTHERWaitlist Hyperbaric Oxygen Therapy
100% oxygen delivered by hood at 2 ATA for 90 minutes with 5 minute air breaks
Sponsors
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Rivermead Post Concussion Syndrome Questionnaire | 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, | 15 questions regarding a participant's Post Concussive symptoms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the NIH Tool Box | Baseline, 2 months post baseline, 8 months post baseline, 14 months post baseline | Cognitive Assessment Cluster |
| Change in the Patient Health Questionnaire (PHQ-9) | Baseline, 2 months post baseline, 8 months post baseline, 14 months post baseline | Depression Assessment |
| Change in the Short Form Health Survey (SF-36) | Baseline, 2 months post baseline, 8 months post baseline, 14 months post baseline | Quality of Life Assessment |
| Change in the Quality of Life After Brain Injury (QOLIBRI) | Baseline, 2 months post baseline, 8 months post baseline, 14 months post baseline | Quality of Life Assessment |
| Change in the WHO Disability Assessment Schedule (WHODAS 2.0) | Baseline, 2 months post baseline, 8 months post baseline, 14 months post baseline | Daily Functioning Assessment |
Countries
Canada
Outcome results
None listed