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.
- Placebo Biological
ARM 1: Kind: Experimental Label: control Description: placebo capsule once per day for 14 days starting day 5-9 post stroke while undergoing usual rehabilitation
- Sildenafil citrate Drug
Other Names: Viagra ARM 1: Kind: Experimental Label: Drug Description: Sildenafil citrate 25mg once per day for 14 days starting day 5-9 post stroke while undergoing usual rehabilitation
- Allocation: Randomized
- Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||Fugl-Meyer Motor Assessment||change from baseline at 1 month||No|
|Primary||Fugl-Meyer Assessment||change from baseline at 3 months||No|
|Secondary||10 meter walk||change from baseline at one month||No|
|Secondary||Wolf Motor Function Test||baseline, one month, three months||No|
|Secondary||Motor Activity Log||one month||No|
|Secondary||Stroke Impact Scale||one month||No|
- University of Utah Lead