NCT00663338已完成2 期
A Multi-centre Exploratory Study to Evaluate the Efficacy of the Dopamine Receptor Agonist Rotigotine in the Treatment of Hemispatial Neglect and Motor Deficits Following Stroke
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Performance on tests of hemispatial neglect and its cognitive components (spatial working memory and sustained attention).
研究概览
简要总结
The aim of this study is to assess the effect of the drug rotigotine on the syndrome of hemispatial neglect and motor deficits following strokes affecting the right hemisphere of the brain.
详细描述
Hemispatial neglect and motor deficits remain major problems following right-hemisphere stroke. This study aims to assess the effect of rotigotine on hemispatial neglect, its component cognitive deficits (including spatial working memory and sustained attention) and motor deficits following right-hemisphere stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed clinical diagnosis of right-hemisphere stroke.
- •Able to give informed consent.
- •Presence of left hemispatial neglect defined by a deficit in finding leftward targets on standard cancellation or visual search tests68-
- •(A deficit on the line bisection test alone will not be sufficient for inclusion, as a previous study shows that there is no significant relationship between performance on this test and spatial working memory capacity37).
- •Presence of motor deficits: all patients will have suffered from first-ever clinically defined stroke resulting in weakness of at least wrist and finger extensors, and hand interossei (to </= 4+ on the Medical Research Council scale), at the time of recruitment.
- •Age over 18 years.
- •More than 9 days since stroke-onset (Note that on our protocol patches do not commence until a minimum of 6 days after the study begins. Thus patients will not receive drug / placebo until a minimum of 15 days post-stroke).
- •Able and willing to use patches of drug/placebo and assessments at regular intervals as defined by the protocol.
- •Able to comply with study requirements.
- •If female and of child-bearing potential, subject has a negative serum pregnancy test within two days of enrollment.
排除标准
- •Pre-existing neurological conditions that would confound cognitive and motor assessments, e.g. dementia, Parkinson's disease, Multiple Sclerosis.
- •Presence of acute concomitant illness, e.g. infection, unstable angina, myocardial infarction or heart, respiratory, renal or liver failure which, based on clinical judgment, would be considered to confound interpretation of results.
- •Systolic blood pressure less than 120 mmHg and / or diastolic less than 70 mmHg.
- •Exposure to any other investigational drug within 30 days of enrollment in the study.
- •History (obtained from patient and medical records) of clinically significant drug or alcohol abuse within 6 months prior to enrollment into the study.
- •Pregnancy (because the effects of rotigotine on the fetus and mother in pregnancy are not known). If female and of child-bearing potential, a serum pregnancy test will be performed within two days of enrollment.
- •Mothers who are breast feeding (because the effects of rotigotine on the newborn have not been established)
研究组 & 干预措施
A
Experimental
All patients receive placebo or rotigotine at some stage in the trial but the exact point is randomized.
干预措施: Rotigotine (Drug)
结局指标
主要结局
Performance on tests of hemispatial neglect and its cognitive components (spatial working memory and sustained attention).
时间窗: 38 days
Tests of motor control.
时间窗: 38 days
次要结局
未报告次要终点
研究者
研究点 (3)
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