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Trial record 1 of 1 for:    NCT03205215
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Hyperbaric Oxygen for Post Concussive Syndrome (HBOT for PCS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03205215
Recruitment Status : Active, not recruiting
First Posted : July 2, 2017
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
David Harrison, University of British Columbia

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

Condition or disease Intervention/treatment Phase
Post-Concussion Syndrome Other: Hyperbaric Oxygen Therapy Other: Waitlist Hyperbaric Oxygen Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hyperbaric Oxygen for Post Concussive Syndrome
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Experimental: Immediate Treatment
This arm will receive hyperbaric oxygen therapy once consented.
Other: Hyperbaric Oxygen Therapy
100% oxygen delivered by hood at 2 ATA for 90 minutes with 5 minute air breaks

Experimental: Waitlist - to be treated
This arm will receive a hyperbaric oxygen therapy after waiting two months.
Other: Waitlist Hyperbaric Oxygen Therapy
100% oxygen delivered by hood at 2 ATA for 90 minutes with 5 minute air breaks




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Change in the NIH Tool Box [ Time Frame: Baseline, 2 months post baseline, 8 months post baseline, 14 months post baseline ]
    Cognitive Assessment Cluster

  2. Change in the Patient Health Questionnaire (PHQ-9) [ Time Frame: Baseline, 2 months post baseline, 8 months post baseline, 14 months post baseline ]
    Depression Assessment

  3. Change in the Short Form Health Survey (SF-36) [ Time Frame: Baseline, 2 months post baseline, 8 months post baseline, 14 months post baseline ]
    Quality of Life Assessment

  4. 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 ]
    Quality of Life Assessment

  5. 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 ]
    Daily Functioning Assessment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03205215


Locations
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Canada, British Columbia
Vancouver General Hospital - Hyperbaric Unit
Vancouver, British Columbia, Canada, V5Z 1M9
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: David W Harrison, MD,CCFP(EM),FRCPC University of British Columbia
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Responsible Party: David Harrison, Medical Manager and Clinical Associate Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT03205215    
Other Study ID Numbers: H18-01291
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by David Harrison, University of British Columbia:
Hyperbaric oxygen
Pressurized oxygen
Concussion
Post concussive syndrome
Oxygen therapy
Additional relevant MeSH terms:
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Post-Concussion Syndrome
Syndrome
Disease
Pathologic Processes
Brain Concussion
Head Injuries, Closed
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Wounds and Injuries
Wounds, Nonpenetrating