Status:
UNKNOWN
American Heart Association- Stroke/Hypoxia Study
Lead Sponsor:
Shirley Ryan AbilityLab
Conditions:
Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Of the 795,000 people who experience a stroke every year in the US, only a small percentage will achieve full recovery. While current therapies promote strength and endurance, none directly address th...
Detailed Description
Stroke is the second leading cause of death and a leading cause of long-term disability worldwide. Despite the spontaneous recovery that occurs following a hemispheric stroke, more than half of stroke...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2024
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04019522
Start Date
July 15 2019
End Date
March 1 2024
Last Update
January 18 2024
Active Locations (1)
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1
Shirley Ryan AbilityLab
Chicago, Illinois, United States, 60611