NL-OMON53065招募中4 期
Randomized trial comparing steered Deep Brain Stimulation with ring-shaped Deep Brain Stimulation for advanced Parkinson*s disease - STEEred vs RING-mode DBS for Parkinson*s disease (STEERING) trial
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 96
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
- •Age >= 18 years
- •bilaterally implanted with the Boston Scientific or Medtronic system in the STN
- •for idiopathic Parkinson*s Disease at least 6 months previous to study
- •the optimal ring-mode stimulation setting has been found for the patient:
- •changing settings will either (a) not improve the motor scores or (b) cause
- •stimulation-induced side-effects
- •Patients who have received this system by participating in the GALAXY-trial can
- •only be randomized after completion of the GALAXY trial.
排除标准
- •no adequate stimulation response in ring-mode on one of the steerable levels
- •(second and third contact point on each lead)
- •Legally incompetent adults
- •Active psychosis
- •No written informed consent
研究者
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