Hyperbaric Oxygen Post Established Stroke "HOPES"

Recruiting

Phase N/A Results N/A

Trial 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.

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 sham group. Participants will not be aware to which group they have been randomized.
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.

Conditions

Interventions

  • Hyperbaric oxygen Other
    Intervention Desc: The only intervention given will be 100% oxygen under hyperbaric pressure.
    ARM 1: Kind: Experimental
    Label: Treatment
    Description: This arm will receive Hyperbaric Oxygen Therapy
  • Sham Hyperbaric Oxygen Other
    Intervention Desc: The only intervention given will be a sham hyperbaric oxygen treatment.
    ARM 1: Kind: Experimental
    Label: Sham
    Description: This arm will receive a sham Hyperbaric Oxygen Therapy.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Outcomes Assessor)
  • Purpose: Treatment
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change in the Stroke Impact Scale (SIS-16) from baseline over the duration of the study Pre treatment (Baseline), During Treatment (3 weeks, 6 weeks) and Post Treatment (9 weeks post baseline, 8 months post and 14 months) No
Secondary National Institute of Health Stroke Scale (NIHSS) Pre treatment (Baseline) and Post Treatment (9 weeks post baseline, 8 months post and 14 months post) No
Secondary Nine hole peg board Pre treatment (Baseline) and Post Treatment (9 weeks post baseline, 8 months post and 14 months post) No
Secondary Grip Strength Pre treatment (Baseline) and Post Treatment (9 weeks post baseline, 8 months post and 14 months post) No
Secondary Berg Balance Test Pre treatment (Baseline) and Post Treatment (9 weeks post baseline, 8 months post and 14 months post) No
Secondary 6 metre walk test Pre treatment (Baseline) and Post Treatment (9 weeks post baseline, 8 months post and 14 months post) No
Secondary 6 minutes walk test Pre treatment (Baseline) and Post Treatment (9 weeks post baseline, 8 months post and 14 months post) No
Secondary Trail Making Test Pre treatment (Baseline) and Post Treatment (Treatment end date, 8 months post and 14 months post) No
Secondary Digital Symbol Substitution Test Pre treatment (Baseline) and Post Treatment (Treatment end date, 8 months post and 14 months post) No
Secondary Centre for Epidemiologic Studies Depression Scale (CESD) Pre treatment (Baseline) and Post Treatment (9 weeks post baseline, 8 months post and 14 months post) No
Secondary Medical Outcomes Study Short Form (SF-36) Pre treatment (Baseline) and Post Treatment (9 weeks post baseline, 8 months post and 14 months post) No
Secondary Montreal Cognitive Assessment (MoCA) Pre treatment (Baseline) and Post Treatment (9 weeks post baseline, 8 months post and 14 months post) No
Secondary Health Economics Questionnaire Pre treatment (Baseline) and Post Treatment (5 months, 8 months, 11 months and 14 months) No

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