Stroke Clinical Trial
Official title:
Sildenafil and Stroke Recovery
This is a small, pilot randomized clinical trial of administering sildenafil citrate to individuals within 10 days of ischemic stroke who have motor impairment and who are undergoing inpatient rehabilitation compared to placebo. The primary outcome is motor recovery at one and three months.
Individuals who are within 4-10 days post ischemic stroke with arm hemiparesis or hemiplegia
who are admitted to inpatient rehabilitation are randomized to receive either sildenafil
citrate (25 mg once per day) or placebo for 14 days. These individuals receive usual
rehabilitation and medical care. Primary outcomes are motor skills and walking speed at one
and three months.
If willing and able, participants undergo an MRI to measure the integrity of the white
matter pathways in the motor system using diffusion tensor imaging. Repeat MRIs are obtained
at one and three months. The investigators will examine if such white matter integrity
predicts response to the drug and if the drug facilitates changes in white matter.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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