HOPES: Hyperbaric Oxygen Post Established Stroke

Sponsor

University of British Columbia (Other)

Overall Status

Unknown status

CT.gov ID

NCT02582502

Collaborator

(none)

140

Enrollment

Location

Arms

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

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	N/A

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

Anticipated 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 :

Oct 1, 2015

Actual Primary Completion Date :

Jan 1, 2020

Anticipated Study Completion Date :

Jul 1, 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.
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.

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.

Outcome Measures

Primary Outcome Measures

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

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.