Post Market Clinical Follow Up Evaluating the Infinity Deep Brain Stimulation Implantable Pulse Generator System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 234
- 试验地点
- 41
- 主要终点
- Percentage Of Participants With Wider Therapeutic Window With Directional Programming (Superiority)
研究概览
简要总结
The purpose of this post-market study is to characterize the clinical performance of the Infinity Deep Brain Stimulation (DBS) system, including the Implantable Pulse Generator (IPG), directional DBS leads, extensions, iPad clinician programmer, iPod patient controller and related system components.
Participants in the PROGRESS study are not assigned to interventional therapy groups. Participants in the PROGRESS study are followed in an observational format as they receive omnidirectional and then directional DBS programming that is part of routine medical care. Data on symptoms are collected during two different stages of programming, and those outcomes compared to assess the effect of omnidirectional or directional programming.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is able to provide informed consent;
- •Subject is diagnosed with Parkinson's disease (PD) and has been recommended to receive an Infinity DBS system with a bilateral DBS implant in the Subthalamic Nucleus (STN), or has received an implant of an Infinity system with bilateral lead implants in the STN;
- •Subject must be available for follow-up visits.
排除标准
- •Subject is not a surgical candidate;
- •In the investigator's opinion, the subject is unable to tolerate multiple programming sessions within a single setting;
- •Subject is unable to comply with the follow-up schedule.
结局指标
主要结局
Percentage Of Participants With Wider Therapeutic Window With Directional Programming (Superiority)
时间窗: 3-month follow-up visit after initial programming
Therapeutic window is the range of stimulation amplitude that produces symptom relief without causing side effects. Proportion of subjects with a wider therapeutic window using directional stimulation, compared to a threshold of 60%. Based on randomized, double-blind evaluation using within-subject control.
次要结局
- Change In UPDRS III Score On and Off Stimulation (Medication On) at 3 and 6 Months(3 and 6 Months Follow-Up Visits)
- Percentage Of Participants With Wider Therapeutic Window With Directional Programming (Non-Inferiority)(3-month follow-up visit after initial programming)