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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | This arm will receive Hyperbaric Oxygen Therapy immediately after consent into study. |
|
| Wait list Treatment | Other | This arm will receive Hyperbaric Oxygen Therapy two months after consenting into study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperbaric Oxygen | Other | The only intervention given will be 100% oxygen under hyperbaric pressure. |
|
| Measure | Description | 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) |
| Measure | Description | 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) |
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Inclusion Criteria:
Exclusion Criteria:
Contraindication to HBOT (Appendix C) including:
Participation in other stroke related studies.
Previous history stroke > 36 months prior to study baseline
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| Name | Affiliation | Role |
|---|---|---|
| David W Harrison, MD,CCFP(EM),FRCPC | Vancouver General Hospital and University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vancouver General Hospital - Hyperbaric Unit | Vancouver | British Columbia | V5Z 1M9 | Canada |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D006931 | Hyperbaric Oxygenation |
| ID | Term |
|---|---|
| D010102 | Oxygen Inhalation Therapy |
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |
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| 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) |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |