Sildenafil and Stroke Recovery
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Fugl-Meyer Motor Assessment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •between 4 and 9 days post-ischemic stroke;
- •admitted to inpatient rehabilitation;
- •cognitively able to provide consent or assent;
- •were living independently in the community prior to their stroke.
排除标准
- •hemorrhagic stroke or subarachnoid hemorrhage;
- •other neurological or psychiatric conditions deemed by the investigator to impair participation;
- •no previous stroke on same side of brain unless that stroke was cerebellar
- •moribound or not expected to live 6 months;
- •contraindications to taking sildenafil in pill or syrup form;
- •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.
- •scores > 50 on the upper extremity section of the Fugl-Meyer or no walking/gait impairment
- •For the MRI portion of the study only:
- •contraindication to MRI: ferrous metal in body, lead included body art, claustrophobia, pacemaker
- •allergic to or had previous reaction to gadolinium
研究组 & 干预措施
Drug
Sildenafil citrate 25mg once per day for 14 days starting day 5-9 post stroke while undergoing usual rehabilitation
干预措施: sildenafil citrate (Drug)
control
placebo capsule once per day for 14 days starting day 5-9 post stroke while undergoing usual rehabilitation
干预措施: Placebo (Drug)
结局指标
主要结局
Fugl-Meyer Motor Assessment
时间窗: change from baseline at 1 month
An assessment of upper extremity and lower extremity motor impairment
Fugl-Meyer Assessment
时间窗: change from baseline at 3 months
An assessment of upper extremity and lower extremity motor impairment
次要结局
- Stroke Impact Scale(3 months)
- 10 meter walk(change from baseline at 3 months)
- Wolf Motor Function Test(change from baseline at 3 months)
- Motor Activity Log(3 months)
研究者
Lorie Richards
Chair and Associate Professor
University of Utah