Hyperbaric Oxygen for Post Concussive Syndrome

Post-Concussion Syndrome Clinical Trial

— HBOT for PCS  

Official title:

Hyperbaric Oxygen for Post Concussive Syndrome

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03205215
• Other study ID #: H18-01291
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: January 2019
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: June 30, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Post-Concussion Syndrome
• Syndrome

Intervention

Other:
• Hyperbaric Oxygen Therapy
100% oxygen delivered by hood at 2 ATA for 90 minutes with 5 minute air breaks
• Waitlist Hyperbaric Oxygen Therapy
100% oxygen delivered by hood at 2 ATA for 90 minutes with 5 minute air breaks

Locations

Country	Name	City	State
Canada	Vancouver General Hospital - Hyperbaric Unit	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in the NIH Tool Box	Cognitive Assessment Cluster	Baseline, 2 months post baseline, 8 months post baseline, 14 months post baseline
Secondary	Change in the Patient Health Questionnaire (PHQ-9)	Depression Assessment	Baseline, 2 months post baseline, 8 months post baseline, 14 months post baseline
Secondary	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
Secondary	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
Secondary	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