Hyperbaric Oxygen Post Established Stroke

Stroke Clinical Trial

— HOPES  

Official title:

Hyperbaric Oxygen Post Established Stroke - HOPES - Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02582502
• Other study ID #: H15-00766
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2015
• Est. completion date: July 2020

Study information

• Verified date: March 2020
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 140
• Est. completion date: July 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Established Stroke
• Ischemic Stroke
• Stroke

Intervention

Other:
• Hyperbaric Oxygen
The only intervention given will be 100% oxygen under hyperbaric pressure.

Locations

Country	Name	City	State
Canada	Vancouver General Hospital - Hyperbaric Unit	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	Grip Strength		Pre treatment (Baseline and after waiting period) and Post Treatment (9 weeks post baseline, 8 months post and 14 months post)
Secondary	Berg Balance Test		Pre treatment (Baseline and after waiting period) and Post Treatment (9 weeks post baseline, 8 months post and 14 months post)
Secondary	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)
Secondary	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)
Secondary	Trail Making Test		Pre treatment (Baseline and after waiting period) and Post Treatment (9 weeks post baseline, 8 months post and 14 months post)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Health Economics Questionnaire		Pre treatment (Baseline and after waiting period) and Post Treatment (5 months, 8 months, 11 months and 14 months)