NCT03037398已完成不适用
Closed Loop Programming Evaluation Using External Responses for Deep Brain Stimulation
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 3
- 主要终点
- Difference in time to program between the two arms at Programming Visit
研究概览
简要总结
The objective of this study is to evaluate the performance of novel DBS programming methods compared to traditional programming methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Implanted bilaterally in STN or GPi with a Vercise™ DBS system for Parkinson's disease, including directional leads, for at least four months and programming optimized according to standard of care with no changes to electrode configuration of primary settings for at least four weeks.
- •Able to understand the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.
- •Be at least 18 years of age.
- •Device must have been implanted on label or must be on label by the time the subject gets enrolled.
排除标准
- •Any significant psychiatric problems, including unrelated clinically significant depression as determined by the investigator.
研究组 & 干预措施
Novel Arm
Active Comparator
Programming completed by a novel method
干预措施: Vercise Deep Brain Stimulation System (Device)
Standard of Care Arm
Other
Programming completed as Standard of care
干预措施: Vercise Deep Brain Stimulation System (Device)
结局指标
主要结局
Difference in time to program between the two arms at Programming Visit
时间窗: at least four months post implant
次要结局
未报告次要终点
研究者
研究点 (3)
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