Stroke
Conditions
Keywords
stroke, rehabilitation, motor skills, sildenafil citrate, White matter
Brief summary
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.
Detailed description
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.
Interventions
DRUGsildenafil citrate
DRUGPlacebo
Sponsors
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. between 4 and 9 days post-ischemic stroke; 2. admitted to inpatient rehabilitation; 3. cognitively able to provide consent or assent; 4. were living independently in the community prior to their stroke.
Exclusion criteria
1. hemorrhagic stroke or subarachnoid hemorrhage; 2. other neurological or psychiatric conditions deemed by the investigator to impair participation; 3. no previous stroke on same side of brain unless that stroke was cerebellar 4. moribound or not expected to live 6 months; 5. contraindications to taking sildenafil in pill or syrup form; 6. other medical conditions that would limit ability to participate in the study, specifically a) currently taking the P450 enzyme inhibitors (erythromycin, ketoconazole, itraconazole, saquinavir), b) currently taking the protease inhibitor ritonavir, c) currently taking nitrates or have a history of requiring nitrates treatment, d) have left ventricular outflow obstruction (i.e., aortic stenosis, idiopathic hypertrophic subaortic stenosis as confirmed by review of standard of care echo received before admission to rehabilitation), e) have severely impaired autonomic control of blood pressure, f) have previous history of symptomatic hypotension, g) have severely impaired hepatic function, h) is pregnant or become pregnant during the course of the study, i) Any medical condition which, in the opinion of the investigator, may compromise compliance with the objectives and/or procedures of the protocol. 7. scores \> 50 on the upper extremity section of the Fugl-Meyer or no walking/gait impairment For the MRI portion of the study only: 8. contraindication to MRI: ferrous metal in body, lead included body art, claustrophobia, pacemaker 9. allergic to or had previous reaction to gadolinium
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Motor Assessment | change from baseline at 1 month | An assessment of upper extremity and lower extremity motor impairment |
| Fugl-Meyer Assessment | change from baseline at 3 months | An assessment of upper extremity and lower extremity motor impairment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wolf Motor Function Test | baseline, one month, three months | An assessment of motor function |
| 10 meter walk | change from baseline at one month | an assessment of usual gait speed |
| Motor Activity Log | one month | A self-report of paretic arm (frequency and perceived ability) use in every day activities |
| Stroke Impact Scale | one month | A self-report measure of the impact of stroke on the individual for body functions, activities, and participation |
Other
| Measure | Time frame | Description |
|---|---|---|
| number of participants with visual side effects | one month | new abnormal color vision, light sensitivity, blurred vision or other visual side effects |
| number of participants with auditory or vestibular side effects | one month | new loss of hearing, tinnitus, dizziness |
| number of participants with cardiovascular side effects | one month | cardiovascular events, such as heart attack, angina pectoris, heart failure |
| Number of participants with unsafe Blood pressure change | one month | blood pressure reductions or increases while taking the drug/placebo |
Countries
United States
Outcome results
None listed