Clinical trial NCT03205215: Hyperbaric Oxygen for Post Concussive Syndrome
Official title: Hyperbaric Oxygen for Post Concussive Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post-Concussion Syndrome
Keywords: Hyperbaric oxygen
Pressurized oxygen
Concussion
Post concussive syndrome
Oxygen therapy
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 150
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in the Rivermead Post Concussion Syndrome Questionnaire
timeFrame: 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 outcomes:
measure: Change in the NIH Tool Box
timeFrame: Baseline, 2 months post baseline, 8 months post baseline, 14 months post baseline
measure: Change in the Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline, 2 months post baseline, 8 months post baseline, 14 months post baseline
measure: Change in the Short Form Health Survey (SF-36)
timeFrame: Baseline, 2 months post baseline, 8 months post baseline, 14 months post baseline
measure: Change in the Quality of Life After Brain Injury (QOLIBRI)
timeFrame: Baseline, 2 months post baseline, 8 months post baseline, 14 months post baseline
measure: Change in the WHO Disability Assessment Schedule (WHODAS 2.0)
timeFrame: Baseline, 2 months post baseline, 8 months post baseline, 14 months post baseline
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital - Hyperbaric Unit
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: David W Harrison, MD,CCFP(EM),FRCPC
role: PRINCIPAL_INVESTIGATOR
References: