Stroke Clinical Trial
Official title:
Hyperbaric Oxygen Post Established Stroke - HOPES - Study
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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