NCT00142259Unknown4 期
Randomisierte, Doppelblinde Langzeitstudie Zur Klinischen Wirksamkeit Der Bilateralen Globus Pallidus Internus-Stimulation Bei Idiopathischer Generalisierter Oder Segmentaler Dystonie
German Parkinson Study Group (GPS)15 个研究点 分布在 2 个国家目标入组 40 人开始时间: 2002年10月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 40
- 试验地点
- 15
- 主要终点
- relative change of the individual Burk-Fahn-Marsden-Dystonia motor score 3 months after treatment compared to baseline
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of bilateral deep brain stimulation of the internal globus pallidus for treating idiopathic generalized or severe segmental dystonia.
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
- Double
入排标准
- 年龄范围
- 14 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of idiopathic multifocal, segmental or generalised dystonia
- •duration of disease > 5 years
- •age between 14 and 75 years
- •relevant disability in activities of daily living despite optimal drug treatment
- •informed consent signed by the patient
- •For adolescents between 14 and 18 years: an additional informed consent signed by a legal guardian is necessary
排除标准
- •Mattis-Score < 120
- •BDI > 25
- •previous stereotactic brain surgery
- •severe brain atrophy
- •increased bleeding risk
- •immunosuppression and increased risk of infection
- •relevant cerebrovascular disease
- •psychiatric disorders, which might interfere with the cooperation in the study
- •other contraindications for surgery
结局指标
主要结局
relative change of the individual Burk-Fahn-Marsden-Dystonia motor score 3 months after treatment compared to baseline
次要结局
- relative change of the individual Burk-Fahn-Marsden-Dystonia ADL score 3 months after treatment compared to baseline
研究者
研究点 (15)
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