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Theta-Burst-Stimulation in early Rehabilitation of Stroke - TheSiReS
niversität zu Köln0 个研究点目标入组 150 人开始时间: 2016年2月16日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 40 Years 至 90 Years（—）
- 性别
- All
入选标准
- •written consent;
- •age: 40-90 years;
- •ischemic stroke;
- •hemiparesis with impaired hand motor function
排除标准
- •Subjects who are legally detained in an official institute (§20 MPG);
- •Participation in clinical trial within the last 12 weeks;
- •Electronic implants or ferromagnetic Implants located in the head, neck or thorax (e.g. clips, intracranial shunt, artificial heart valve, pacemaker);
- •Medication pump (e.g. insulin pump);
- •Metal splinters in eye or head;
- •Pregnancy / breastfeeding;
- •Severe Neurodegenerative disease;
- •Severe Neuroinflammatory disease;
- •History of seizures / epilepsy;
- •Physical addiction to alcohol, medication, or drugs (excluded: nicotine);
- •Insufficient compliance;
- •Present or past malignant tumor involving the central nervous system;
- •Severe Psychiatric disease;
- •Clinically manifest bilateral hemiparesis or infarcts in the primary motor cortex or along the tractus corticospinalis in the hemisphere ipsilateral to the hemiparesis;
- •Pre-existing cerebral infarctions with hemiparesis or pre-existing cerebral infarctions in the primary motor cortex or along the tractus corticospinalis, excluding microangiopathic changes (e.g. clinically asymptomatic lacunae <1cm);
- •Known brain lesion (surgical, traumatic);
- •Evidence for enhanced cerebral pressure;
- •Severe cardial dysfunction;
- •life expectancy < 12 months;
- •NIHSS Score > 20;
- •Blood glucose imbalances resistant to treatment (<50 mg/dl or >300 mg/dl);
- •Elevated blood pressure resistant to treatment (RR > 185/110mmHg);
- •Systemic Thrombolysis using r-tPA or thrombectomy within the last 24 hours before enrollment in study;
- •Medication with benzodiazepines, high-potency antipsychotics or tricyclic antidepressants before hospitalization or long-term during hospitalization
研究者
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