American Heart Association- Stroke/Hypoxia Study
Stroke
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
Inclusion criteria:
Age ≥18 years;
A first time, unilateral, ischemic, hemispheric stroke, confirmed by magnetic resonance imaging (MRI);
Chedoke assessment > 3
Ability to open and close affected hand
Able to understand and communicate in English
Be able to consent independently
≥ 6 months post stroke
Must have a hemoglobin level above 10g/dl (to be confirmed using handheld noninvasive lab equipment)
Must have ability to attend research visits with a companion for assistance
WOCBP must be comfortable confirming negative pregnancy prior to hypoxia experimental therapy.
Exclusion criteria:
Brain stem or cerebellar stroke; mean Fazekas score rated on initial fluid-attenuated inversion recovery MRI ≥3
Severe aphasia, preventing subject from understanding the protocol and giving written consent;
History of prior neurological disorder;
Pre-existing hypoxic pulmonary disease,
Severe hypertension (>160/100)
Ischemic cardiac disease.
Sites / Locations
- Shirley Ryan AbilityLab
Arms of the Study
Arm 1
Experimental
Hypoxia
During each session, study participants will receive a single sequence of AIH, consisting of 15 x 60-seconds periods of hypoxia alternating with 90-seconds of normoxia (21% O2), for a total of 30 minutes, whilst in a seated upright position. AIH will be applied by directing gas flow to a reservoir bag connected via plastic tubing to a non re-breathing facemask/respiratory valve system while the participants are in a seated position. Defined gas mixtures will be delivered by manual adjustment of one-way valves attached to a hypoxia generator.