Hyperbaric Oxygen for Post Concussive Syndrome (HBOT for PCS)

University of British Columbia

Status: Unknown

Conditions: Post-Concussion Syndrome

Treatments: Other: Waitlist Hyperbaric Oxygen Therapy; Other: Hyperbaric Oxygen Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03205215

H18-01291

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 19 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

150 participants in 2 patient groups

Immediate Treatment

Experimental group

Description:

This arm will receive hyperbaric oxygen therapy once consented.

Treatment:

Other: Hyperbaric Oxygen Therapy

Waitlist - to be treated

Experimental group

Description:

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

Treatment:

Other: Waitlist Hyperbaric Oxygen Therapy