Hyperbaric Oxygen Post Established Stroke

NCT ID: NCT02582502

Last Updated: 2020-03-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2020-07-31

Brief Summary

The purpose of this study is to examine the role of Hyperbaric Oxygen Therapy (HBOT) in improving neurological function in patients who are 6 to 36 months post ischemic stroke.

Detailed Description

The purpose of this study is to examine the role of Hyperbaric Oxygen Therapy (HBOT) in improving neurological function in patients who are 6 to 36 months post ischemic stroke.

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. Some of these effects have been postulated to be beneficial in the context of ischemic stroke.

Most of the recovery after stroke occurs in the first 30 to 90 days after the acute event. Recovery is largely based on recovery of brain that is injured, but viable. Physiological imaging studies (PET, EEG) have demonstrated that brain tissue may remain alive but not functional for months or years after ischemic insult.

Subjects will be selected from the stroke population based on an expectation that they would experience a clinically significant improvement. Eligible subjects will have suffered an ischemic stroke involving the cerebral cortex within the last 6 to 36 months. The study will be enrolling 140 subjects and will be randomized to two different treatment arms: experimental group and a waitlist group.

Each subject 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, 3 weeks and 6 weeks into treatment and then again at the end of treatment. After treatment ends, the investigators will conduct these assessments again at 3 months, 6 months, 9 months and 1 year from the date of the participants last treatment.

Conditions

Stroke; Ischemic Stroke; Established Stroke

Study Design

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

Study Groups

Treatment

This arm will receive Hyperbaric Oxygen Therapy immediately after consent into study.

Group Type: EXPERIMENTAL

Hyperbaric Oxygen

Intervention Type: OTHER

The only intervention given will be 100% oxygen under hyperbaric pressure.

Wait list Treatment

This arm will receive Hyperbaric Oxygen Therapy two months after consenting into study.

Group Type: OTHER

Hyperbaric Oxygen

Intervention Type: OTHER

The only intervention given will be 100% oxygen under hyperbaric pressure.

Interventions

Hyperbaric Oxygen

The only intervention given will be 100% oxygen under hyperbaric pressure.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Age between 19 and 85.

2. Able to speak English and give informed consent or have a substitute decision maker and able to assent.

3. One or more ischemic stroke(s) involving the cerebral cortex or cerebellum within the last 6 to 36 months

4. Able to sit in the chamber with the assistance of a waist and chest strap for 120 minutes.

Exclusion Criteria

1. Contraindication to HBOT (Appendix C) including:

1. Untreated collapsed lung (pneumothorax)

2. Have taken the chemotherapy drug Doxorubicin within 72 hours

3. Have taken the chemotherapy drug Bleomycin within 4 months

4. Bowel obstruction

5. Heart pacemaker of unknown make and model

6. Pregnancy

7. Cigarette Smoking

8. Chronic Obstructive Pulmonary Disease (COPD)

2. Participation in other stroke related studies.

3. Previous history stroke > 36 months prior to study baseline

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

David Harrison

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Vancouver General Hospital and University of British Columbia

Locations

Vancouver General Hospital - Hyperbaric Unit

Vancouver, British Columbia, Canada

Countries

Canada

Other Identifiers

H15-00766

Identifier Type: -

Identifier Source: org_study_id