Registry of Deep Brain Stimulation With the VERCISE™ System: Vercise DBS Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,500
- 试验地点
- 105
- 主要终点
- Improvement in patient's quality of life (QoL) during the study as compared with baseline
研究概览
简要总结
The purpose of this registry is to compile characteristics of world-wide outcomes for the use of Boston Scientific's commercially available Vercise DBS System in the treatment of Parkinson's disease.
The utilization of Image Guided Programming (IGP), and other commercially available programming features, used as planning tools for the programming of patients with Boston Scientific's Vercise DBS System are also evaluated.
Additionally, the utilization of the DBS Illumina 3D feature that may be used for the programming of patients with Boston Scientific's Vercise DBS Systems is also evaluated.
详细描述
The purpose of this registry is to compile characteristics of world-wide outcomes for the use of Boston Scientific's commercially available Vercise DBS system in the treatment of Parkinson's disease.
Subjects' improvement in disease symptoms and overall Quality of life will be assessed during the study following DBS and compared with baseline. Additionally, the utilization of Image Guided Programming (IGP) when used as a planning tool for programming of patients is also evaluated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Meets criteria established in locally applicable Vercise System Direction for Use
- •At least 18 years old
排除标准
- •Meets any contraindication in the Vercise System locally applicable Directions for Use
- •Subjects with significant cognitive or psychiatric impairment may be excluded in the evaluation of GXT.
研究组 & 干预措施
Parkinson's disease
Subjects with Parkinson's disease who will receive Vercise DBS for deep brain stimulation.
干预措施: Deep Brain Stimulation (DBS) (Device)
结局指标
主要结局
Improvement in patient's quality of life (QoL) during the study as compared with baseline
时间窗: up to 3 years
Change in quality of life assessments during the study as compared with baseline
次要结局
未报告次要终点