Hyperbaric Oxygen for Post Concussive Syndrome (HBOT for PCS)

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

Study Overview

• Status: Unknown
• Conditions: Post-Concussion Syndrome
• Intervention / Treatment: Other: Hyperbaric Oxygen Therapy; Other: Waitlist Hyperbaric Oxygen Therapy

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 Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Vancouver General Hospital - Hyperbaric Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of British Columbia
• Investigators: Principal Investigator: David W Harrison, MD,CCFP(EM),FRCPC, University of British Columbia

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2018
• Primary Completion (ANTICIPATED): December 30, 2019
• Study Completion (ANTICIPATED): June 30, 2020

Study Registration Dates

• First Submitted: June 27, 2017
• First Submitted That Met QC Criteria: June 28, 2017
• First Posted (ACTUAL): July 2, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 18, 2019
• Last Update Submitted That Met QC Criteria: January 16, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Concussion; Oxygen therapy; Hyperbaric oxygen; Post concussive syndrome; Pressurized oxygen
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Craniocerebral Trauma; Trauma, Nervous System; Brain Concussion; Head Injuries, Closed; Wounds, Nonpenetrating; Syndrome; Post-Concussion Syndrome
• Other Study ID Numbers: H18-01291

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No