Hyperbaric Oxygen Post Established Stroke (HOPES)

Hyperbaric Oxygen Post Established Stroke - HOPES - Study

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.

Study Overview

• Status: Unknown
• Conditions: Stroke; Ischemic Stroke; Established Stroke
• Intervention / Treatment: Other: Hyperbaric Oxygen

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.

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Vancouver General Hospital - Hyperbaric Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; This arm will receive Hyperbaric Oxygen Therapy immediately after consent into study.	Other: Hyperbaric Oxygen; The only intervention given will be 100% oxygen under hyperbaric pressure.
Other: Wait list Treatment; This arm will receive Hyperbaric Oxygen Therapy two months after consenting into study.	Other: Hyperbaric Oxygen; The only intervention given will be 100% oxygen under hyperbaric pressure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in the Stroke Impact Scale (SIS-16) from baseline over the duration of the study	Pre treatment (Baseline and after waiting period is completed), During Treatment (3 weeks, 6 weeks) and Post Treatment (9 weeks post baseline, 8 months post and 14 months)

Secondary Outcome Measures

Outcome Measure	Time Frame
National Institute of Health Stroke Scale (NIHSS)	Pre treatment (Baseline and after waiting period) and Post Treatment (9 weeks post baseline, 8 months post and 14 months post)
Nine hole peg board	Pre treatment (Baseline and after waiting period) and Post Treatment (9 weeks post baseline, 8 months post and 14 months post)
Grip Strength	Pre treatment (Baseline and after waiting period) and Post Treatment (9 weeks post baseline, 8 months post and 14 months post)
Berg Balance Test	Pre treatment (Baseline and after waiting period) and Post Treatment (9 weeks post baseline, 8 months post and 14 months post)
6 metre walk test	Pre treatment (Baseline and after waiting period) and Post Treatment (9 weeks post baseline, 8 months post and 14 months post)
6 minutes walk test	Pre treatment (Baseline and after waiting period) and Post Treatment (9 weeks post baseline, 8 months post and 14 months post)
Trail Making Test	Pre treatment (Baseline and after waiting period) and Post Treatment (9 weeks post baseline, 8 months post and 14 months post)
Digital Symbol Substitution Test	Pre treatment (Baseline and after waiting period) and Post Treatment (9 weeks post baseline, 8 months post and 14 months post)
Centre for Epidemiologic Studies Depression Scale (CESD)	Pre treatment (Baseline and after waiting period) and Post Treatment (9 weeks post baseline, 8 months post and 14 months post)
Medical Outcomes Study Short Form (SF-36)	Pre treatment (Baseline and after waiting period) and Post Treatment (9 weeks post baseline, 8 months post and 14 months post)
Montreal Cognitive Assessment (MoCA)	Pre treatment (Baseline and after waiting period) and Post Treatment (9 weeks post baseline, 8 months post and 14 months post)
Health Economics Questionnaire	Pre treatment (Baseline and after waiting period) and Post Treatment (5 months, 8 months, 11 months and 14 months)

Collaborators and Investigators

• Sponsor: University of British Columbia
• Investigators: Principal Investigator: David W Harrison, MD,CCFP(EM),FRCPC, Vancouver General Hospital and University of British Columbia

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): January 1, 2020
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: September 29, 2015
• First Submitted That Met QC Criteria: October 20, 2015
• First Posted (Estimate): October 21, 2015

Study Record Updates

• Last Update Posted (Actual): March 27, 2020
• Last Update Submitted That Met QC Criteria: March 26, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Hyperbaric Oxygen; HBOT; Hyperbaric Chamber; Pressurized Oxygen
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: H15-00766

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No