■中风恢复需要新的治疗方法。目前尚不清楚药物治疗是否有利于促进中风恢复。多巴胺是一种参与运动学习的神经递质,奖励,和大脑可塑性。其前药左旋多巴是中风恢复的有前途的药物。
■为了研究左旋多巴,除了基于主动任务训练的标准化康复治疗之外,与安慰剂相比,急性缺血性或出血性卒中患者的功能恢复增强。
■ESTREL(左旋多巴增强中风康复)是随机的(比例为1:1),多中心,安慰剂对照,双盲,平行组优势试验。
■610名具有临床意义的偏瘫的参与者(根据样本量计算)将在中风发作后7天注册。主要资格标准包括(I)需要住院康复,(ii)参与康复的能力,(3)日常生活中的独立性。
■左旋多巴100毫克/卡比多巴25毫克,每日三次,给药5周,除了标准化康复。研究干预将在中风发作后7天内开始。
■匹配安慰剂加标准化康复。
■主要结果是随机化后3个月测量的Fugl-Meyer-运动评估(FMMA)总分的组间差异。次要结果包括患者报告的健康和福祉(PROMIS10和29),患者报告的改善评估,Rivermead流动性指数,改良的Rankin量表,美国国立卫生研究院卒中量表(NIHSS),作为伤害的衡量标准:死亡率,复发性中风,和严重不良事件。
■ESTREL试验将提供证据,证明与单独康复相比,在中风患者中除标准化康复外使用左旋多巴是否会导致更好的功能恢复。
UNASSIGNED: Novel therapeutic approaches are needed in stroke recovery. Whether pharmacological therapies are beneficial for enhancing stroke recovery is unclear. Dopamine is a neurotransmitter involved in motor learning, reward, and brain plasticity. Its prodrug levodopa is a promising agent for stroke recovery.
UNASSIGNED: To investigate the hypothesis that levodopa, in addition to standardized rehabilitation therapy based on active task training, results in an enhancement of functional recovery in acute ischemic or hemorrhagic stroke patients compared to placebo.
UNASSIGNED: ESTREL (Enhancement of Stroke REhabilitation with Levodopa) is a randomized (ratio 1:1), multicenter, placebo-controlled, double-blind, parallel-group superiority trial.
UNASSIGNED: 610 participants (according to sample size calculation) with a clinically meaningful hemiparesis will be enrolled ⩽7 days after stroke onset. Key eligibility criteria include (i) in-hospital-rehabilitation required, (ii) capability to participate in rehabilitation, (iii) previous independence in daily living.
UNASSIGNED: Levodopa 100 mg/carbidopa 25 mg three times daily, administered for 5 weeks in addition to standardized rehabilitation. The study intervention will be initiated within 7 days after stroke onset.
UNASSIGNED: Matching placebo plus standardized rehabilitation.
UNASSIGNED: The primary outcome is the between-group difference of the Fugl-Meyer-Motor Assessment (FMMA) total score measured 3 months after randomization. Secondary outcomes include patient-reported health and wellbeing (PROMIS 10 and 29), patient-reported assessment of improvement, Rivermead Mobility Index, modified Rankin Scale, National Institutes of Health Stroke Scale (NIHSS), and as measures of harm: mortality, recurrent stroke, and serious adverse events.
UNASSIGNED: The ESTREL trial will provide evidence of whether the use of Levodopa in addition to standardized rehabilitation in stroke patients leads to better functional recovery compared to rehabilitation alone.