Post-Concussion SyndromeHBOT for PCSNCT03205215
Hyperbaric Oxygen for Post Concussive Syndrome
A study testing Hyperbaric Oxygen Therapy and Waitlist Hyperbaric Oxygen Therapy in people with Post-Concussion Syndrome, run by University of British Columbia at 1 site in Canada.
Trial summary
We would like to see if Hyperbaric Oxygen can help improve the symptoms that result from Post Concussive Syndrome. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Post-Concussion Syndrome
- What is being tested?
- Hyperbaric Oxygen Therapy and Waitlist Hyperbaric Oxygen Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2018to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- Severe Chronic Obstructive Pulmonary Disease (COPD)
- Participation in other PCS related studies.
- Previous recent HBOT
- Previous recent deep sea diving experience
Trial locations and contacts
1 site in 1 country.
Canada1 site
Vancouver General Hospital - Hyperbaric Unit
Vancouver, British Columbia, V5Z 1M9
About this study
We would like to see if Hyperbaric Oxygen can help improve the symptoms that result from Post Concussive Syndrome.
Read the 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.
- Conditions
- Post-Concussion Syndrome
- Being tested
- Hyperbaric Oxygen Therapy, Waitlist Hyperbaric Oxygen Therapy
- Keywords
- Hyperbaric oxygen, Pressurized oxygen, Concussion, Post concussive syndrome, Oxygen therapy
- Medical subject headings
- Post-Concussion Syndrome, Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric Oxygen TherapyOther
100% oxygen delivered by hood at 2 ATA for 90 minutes with 5 minute air breaks
Waitlist Hyperbaric Oxygen TherapyOther
100% oxygen delivered by hood at 2 ATA for 90 minutes with 5 minute air breaks
| Study group | Role | What they receive |
|---|---|---|
| Immediate Treatment | Experimental | This arm will receive hyperbaric oxygen therapy once consented. Receives: Other: Hyperbaric Oxygen Therapy |
| Waitlist - to be treated | Experimental | This arm will receive a hyperbaric oxygen therapy after waiting two months. Receives: Other: Waitlist Hyperbaric Oxygen Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Rivermead Post Concussion Syndrome Questionnaire
15 questions regarding a participant's Post Concussive symptoms
Measured: 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 outcomes (5)
Change in the NIH Tool Box
Cognitive Assessment Cluster
Measured: Baseline, 2 months post baseline, 8 months post baseline, 14 months post baseline
Change in the Patient Health Questionnaire (PHQ-9)
Depression Assessment
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, 2 months post baseline, 8 months post baseline, 14 months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start1 Sep 2018
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Concussion SyndromeStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Harrison, University of British Columbia
- Investigators
- David W Harrison, MD,CCFP(EM),FRCPC, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03205215
- Sponsor's protocol ID
- H18-01291
- Acronym
- HBOT for PCS
- Status last verified
- Jan 2019
- First submitted
- 27 Jun 2017
- Last updated
- 18 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperbaric Oxygen for Post Concussive Syndrome
- ClinicalTrials.gov ID
- NCT03205215
- Acronym / sponsor ID
- HBOT for PCS / H18-01291
- Conditions
- Post-Concussion Syndrome
- Keywords
- Hyperbaric oxygen, Pressurized oxygen, Concussion, Post concussive syndrome, Oxygen therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 2 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Treatment | Experimental | Other: Hyperbaric Oxygen TherapyThis arm will receive hyperbaric oxygen therapy once consented. |
| Waitlist - to be treated | Experimental | Other: Waitlist Hyperbaric Oxygen TherapyThis arm will receive a hyperbaric oxygen therapy after waiting two months. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric Oxygen Therapy100% oxygen delivered by hood at 2 ATA for 90 minutes with 5 minute air breaks | Other | Immediate Treatment |
| Waitlist Hyperbaric Oxygen Therapy100% oxygen delivered by hood at 2 ATA for 90 minutes with 5 minute air breaks | Other | Waitlist - to be treated |
Primary outcome
Change in the Rivermead Post Concussion Syndrome Questionnaire
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,
15 questions regarding a participant's Post Concussive symptoms
5 secondary outcomes
Change in the NIH Tool Box
Time frame: Baseline, 2 months post baseline, 8 months post baseline, 14 months post baseline
Change in the Patient Health Questionnaire (PHQ-9)
Time frame: Baseline, 2 months post baseline, 8 months post baseline, 14 months post baseline
Change in the Short Form Health Survey (SF-36)
Time frame: Baseline, 2 months post baseline, 8 months post baseline, 14 months post baseline
Change in the Quality of Life After Brain Injury (QOLIBRI)
Time frame: Baseline, 2 months post baseline, 8 months post baseline, 14 months post baseline
Change in the WHO Disability Assessment Schedule (WHODAS 2.0)
Time frame: Baseline, 2 months post baseline, 8 months post baseline, 14 months post baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2019.
- Individual participant dataSharing planned: No
Related trials for Post-Concussion Syndrome
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David W Harrison, MD,CCFP(EM),FRCPC principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperbaric Oxygen Therapy and Waitlist Hyperbaric Oxygen Therapy in people with Post-Concussion Syndrome, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Rivermead Post Concussion Syndrome Questionnaire (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,). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2019.