Hyperbaric Oxygen Post Established Stroke (HOPES)

• ClinicalTrials.gov Identifier: NCT02582502
• Recruitment Status: Unknown
• First Posted: October 21, 2015
• Last Update Posted: March 27, 2020
• Sponsor: University of British Columbia
• Information provided by (Responsible Party): David Harrison, University of British Columbia

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Stroke; Ischemic Stroke; Established Stroke	Other: Hyperbaric Oxygen	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 140 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Hyperbaric Oxygen Post Established Stroke - HOPES - Study
• Study Start Date: October 2015
• Actual Primary Completion Date: January 2020
• Estimated Study Completion Date: July 2020

Arms and Interventions

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.
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.

Outcome Measures

Primary Outcome Measures :

1. Change in the Stroke Impact Scale (SIS-16) from baseline over the duration of the study [ Time Frame: 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 :

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

Eligibility Criteria

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

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

Contacts and Locations

Locations

Canada, British Columbia

Vancouver General Hospital - Hyperbaric Unit

Vancouver, British Columbia, Canada, V5Z 1M9

Sponsors and Collaborators

University of British Columbia

Investigators

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

More Information

• Responsible Party: David Harrison, Principal Investigator, University of British Columbia
• ClinicalTrials.gov Identifier: NCT02582502
• Other Study ID Numbers: H15-00766
• First Posted: October 21, 2015
• Last Update Posted: March 27, 2020
• Last Verified: March 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by David Harrison, University of British Columbia:

Hyperbaric Oxygen; HBOT; Hyperbaric Chamber; Pressurized Oxygen

Additional relevant MeSH terms:

Stroke; Ischemic Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases