Hyperbaric Oxygen for Post Concussive Syndrome

NCT ID: NCT03205215

Last Updated: 2019-01-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2020-06-30

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.

Conditions

Post-Concussion Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Immediate Treatment

This arm will receive hyperbaric oxygen therapy once consented.

Group Type: EXPERIMENTAL

Hyperbaric Oxygen Therapy

Intervention Type: OTHER

100% oxygen delivered by hood at 2 ATA for 90 minutes with 5 minute air breaks

Waitlist - to be treated

This arm will receive a hyperbaric oxygen therapy after waiting two months.

Group Type: EXPERIMENTAL

Waitlist Hyperbaric Oxygen Therapy

Intervention Type: OTHER

100% oxygen delivered by hood at 2 ATA for 90 minutes with 5 minute air breaks

Interventions

Hyperbaric Oxygen Therapy

100% oxygen delivered by hood at 2 ATA for 90 minutes with 5 minute air breaks

Intervention Type: OTHER

Waitlist Hyperbaric Oxygen Therapy

100% oxygen delivered by hood at 2 ATA for 90 minutes with 5 minute air breaks

Intervention Type: OTHER

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

David Harrison

Medical Manager and Clinical Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David W Harrison, MD,CCFP(EM),FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

Vancouver General Hospital - Hyperbaric Unit

Vancouver, British Columbia, Canada

Countries

Canada

Other Identifiers

H18-01291

Identifier Type: -

Identifier Source: org_study_id