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Hyperbaric Oxygen Post Established Stroke (HOPES)

Primary Purpose

Stroke, Ischemic Stroke, Established Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Hyperbaric Oxygen
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Hyperbaric Oxygen, HBOT, Hyperbaric Chamber, Pressurized Oxygen

Eligibility Criteria

19 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vancouver General Hospital - Hyperbaric Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Treatment

Wait list Treatment

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in the Stroke Impact Scale (SIS-16) from baseline over the duration of the study

Secondary Outcome Measures

National Institute of Health Stroke Scale (NIHSS)
Nine hole peg board
Grip Strength
Berg Balance Test
6 metre walk test
6 minutes walk test
Trail Making Test
Digital Symbol Substitution Test
Centre for Epidemiologic Studies Depression Scale (CESD)
Medical Outcomes Study Short Form (SF-36)
Montreal Cognitive Assessment (MoCA)
Health Economics Questionnaire

Full Information

First Posted
September 29, 2015
Last Updated
March 26, 2020
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT02582502
Brief Title
Hyperbaric Oxygen Post Established Stroke
Acronym
HOPES
Official Title
Hyperbaric Oxygen Post Established Stroke - HOPES - Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
January 2020 (Actual)
Study Completion Date
July 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic Stroke, Established Stroke
Keywords
Hyperbaric Oxygen, HBOT, Hyperbaric Chamber, Pressurized Oxygen

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
This arm will receive Hyperbaric Oxygen Therapy immediately after consent into study.
Arm Title
Wait list Treatment
Arm Type
Other
Arm Description
This arm will receive Hyperbaric Oxygen Therapy two months after consenting into study.
Intervention Type
Other
Intervention Name(s)
Hyperbaric Oxygen
Intervention Description
The only intervention given will be 100% oxygen under hyperbaric pressure.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
Health Economics Questionnaire
Time Frame
Pre treatment (Baseline and after waiting period) and Post Treatment (5 months, 8 months, 11 months and 14 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 19 and 85. Able to speak English and give informed consent or have a substitute decision maker and able to assent. One or more ischemic stroke(s) involving the cerebral cortex or cerebellum within the last 6 to 36 months Able to sit in the chamber with the assistance of a waist and chest strap for 120 minutes. Exclusion Criteria: Contraindication to HBOT (Appendix C) including: 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 of unknown make and model Pregnancy Cigarette Smoking Chronic Obstructive Pulmonary Disease (COPD) Participation in other stroke related studies. Previous history stroke > 36 months prior to study baseline
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David W Harrison, MD,CCFP(EM),FRCPC
Organizational Affiliation
Vancouver General Hospital and University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vancouver General Hospital - Hyperbaric Unit
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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