NL-OMON39143已完成4 期
A randomized, controlled, open-label, parallel-group, multi-center study to compare the effect of Intrathecal Baclofen Therapy (ITB Therapy®) versus Best Medical Treatment (BMT) on spasticity in post-stroke patients after 6 months active treatment - SISTERS: Spasticity in Stroke * Randomized Study
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Medtronic
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- 18-75 years old
- •- stroke not more than 6 months ago
- •- spasticity in 2 extremities
- •- Ashworth score > 2
- •- patient suitable acc. Adult Spasticity Algorithm (not enough effect with other treatments)
- •- stable blood pressure
- •- not pregnant
排除标准
- •- acute systemic infection
- •- presence of pacemaker, ICD, neurostimulator, drug delivery system
- •- oncontrolled refractoire epilepsy
- •- use of vitamin K antagonists
- •- preganant or breast feeding
- •- Botuline toxine injection less than 4 months ago
- •- Patient not able to give his/her informed consent himself/herself
研究者
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