Hyperbaric Oxygen for Post Concussive Syndrome (HBOT for PCS)
Primary Purpose
Post-Concussion Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Hyperbaric Oxygen Therapy
Waitlist Hyperbaric Oxygen Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Post-Concussion Syndrome focused on measuring Hyperbaric oxygen, Pressurized oxygen, Concussion, Post concussive syndrome, Oxygen therapy
Eligibility Criteria
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
Sites / Locations
- Vancouver General Hospital - Hyperbaric Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Immediate Treatment
Waitlist - to be treated
Arm Description
This arm will receive hyperbaric oxygen therapy once consented.
This arm will receive a hyperbaric oxygen therapy after waiting two months.
Outcomes
Primary Outcome Measures
Change in the Rivermead Post Concussion Syndrome Questionnaire
15 questions regarding a participant's Post Concussive symptoms
Secondary Outcome Measures
Change in the NIH Tool Box
Cognitive Assessment Cluster
Change in the Patient Health Questionnaire (PHQ-9)
Depression Assessment
Change in the Short Form Health Survey (SF-36)
Quality of Life Assessment
Change in the Quality of Life After Brain Injury (QOLIBRI)
Quality of Life Assessment
Change in the WHO Disability Assessment Schedule (WHODAS 2.0)
Daily Functioning Assessment
Full Information
NCT ID
NCT03205215
First Posted
June 27, 2017
Last Updated
January 16, 2019
Sponsor
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT03205215
Brief Title
Hyperbaric Oxygen for Post Concussive Syndrome
Acronym
HBOT for PCS
Official Title
Hyperbaric Oxygen for Post Concussive Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
December 30, 2019 (Anticipated)
Study Completion Date
June 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Concussion Syndrome
Keywords
Hyperbaric oxygen, Pressurized oxygen, Concussion, Post concussive syndrome, Oxygen therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Immediate Treatment
Arm Type
Experimental
Arm Description
This arm will receive hyperbaric oxygen therapy once consented.
Arm Title
Waitlist - to be treated
Arm Type
Experimental
Arm Description
This arm will receive a hyperbaric oxygen therapy after waiting two months.
Intervention Type
Other
Intervention Name(s)
Hyperbaric Oxygen Therapy
Intervention Description
100% oxygen delivered by hood at 2 ATA for 90 minutes with 5 minute air breaks
Intervention Type
Other
Intervention Name(s)
Waitlist Hyperbaric Oxygen Therapy
Intervention Description
100% oxygen delivered by hood at 2 ATA for 90 minutes with 5 minute air breaks
Primary Outcome Measure Information:
Title
Change in the Rivermead Post Concussion Syndrome Questionnaire
Description
15 questions regarding a participant's Post Concussive symptoms
Time Frame
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 Measure Information:
Title
Change in the NIH Tool Box
Description
Cognitive Assessment Cluster
Time Frame
Baseline, 2 months post baseline, 8 months post baseline, 14 months post baseline
Title
Change in the Patient Health Questionnaire (PHQ-9)
Description
Depression Assessment
Time Frame
Baseline, 2 months post baseline, 8 months post baseline, 14 months post baseline
Title
Change in the Short Form Health Survey (SF-36)
Description
Quality of Life Assessment
Time Frame
Baseline, 2 months post baseline, 8 months post baseline, 14 months post baseline
Title
Change in the Quality of Life After Brain Injury (QOLIBRI)
Description
Quality of Life Assessment
Time Frame
Baseline, 2 months post baseline, 8 months post baseline, 14 months post baseline
Title
Change in the WHO Disability Assessment Schedule (WHODAS 2.0)
Description
Daily Functioning Assessment
Time Frame
Baseline, 2 months post baseline, 8 months post baseline, 14 months post baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David W Harrison, MD,CCFP(EM),FRCPC
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vancouver General Hospital - Hyperbaric Unit
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Hyperbaric Oxygen for Post Concussive Syndrome
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