Status:Not yet recruiting
Keywords:stroke , rehabilitation , motor skills , sildenafil
The aim of this study is to determine safety, feasibility and effect on stroke recovery of administering sildenafil to participants with acute stroke. We expect that we will be able to recruit our target number of participants, demonstrate that it is feasible to retain them in the study without serious adverse effects related to the study or side effects uncomfortable enough to cause them to drop out of the study, and that we will be able to calculate a valid effect size for each group.
An additional purpose of this study is to examine the brain white matter and activation changes in the motor system following this therapy in order to delineate neural mechanisms of stroke recovery associated with this therapy.
A double blind randomized, controlled trial will be used. Participants will be randomized to receive 25mg of sildenafil or placebo the day after baseline testing is completed, but no later than day 11 post-stroke and will continue for the next 14 days. They will continue with usual rehabilitation. The occupational and physical therapists providing rehabilitation will record the content of each therapy session. Participants will be tested for upper extremity and lower extremity motor function at baseline, and then every week during inpatient rehabilitation. They will be retested at 1 month and at 3 months following inpatient rehabilitation. The amount and type of therapy they receive during this follow-up period will also be monitored.
1) 18-80 years old;
2) between 4 and 9 days post-first ischemic stroke;
3) admitted to inpatient rehabilitation;
4) able to voluntarily move the upper extremity;
5) cognitively able to provide consent or assent;
6) were living independently in the community prior to their stroke.
1) hemorrhagic stroke or subarachnoid hemorrhage;
2) other neurological or psychiatric conditions deemed by the investigator to impair participation;
3) moribound or not expected to live 6 months;
4) contraindications to taking sildenafil in pill or syrup form;
5) 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.
For the MRI portion of the study only:
6) contraindication to MRI: ferrous metal in body, lead included body art, claustrophobia, pacemaker
7) allergic to or had previous reaction to gadolinium