Visualization of the STN and GPi for DBS Surgery in Patients With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 80
- 试验地点
- 10
- 主要终点
- Measure Euclidean distance (mm) between the planned target coordinate and actual implanted coordinate
研究概览
简要总结
The purpose of the study is to determine if using SIS System for DBS planning results in less distance between the planned target location and the actual implanted lead location than DBS planning without SIS System.
详细描述
This is a prospective, controlled, open-label, multicenter post-market trial to compare standard of care DBS surgery to standard of care plus visualization with the SIS System. The purpose of the study is to determine if using SIS System for DBS planning results in less distance between the planned target location and the actual implanted lead location than DBS planning without SIS System.
Parkinson's Disease subjects indicated for DBS will undergo standard DBS surgery with preoperative planning for targeting of STN or GPi as indicated. Subjects will be followed through six months after initial DBS programming to collect clinical outcomes.
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
- •Subject is diagnosed with Idiopathic Parkinson's Disease and is indicated for de novo DBS surgery with bilateral DBS leads implanted in the STN or GPi.
- •Subject is 18 years or older.
- •Subject must be able and willing to provide informed consent and comply with study follow-up schedule and procedures.
排除标准
- •Subject is not a DBS surgical candidate due to untreated, clinically significant depression, current suicidal ideation, or dementia or any neuropsychological condition or finding that would contraindicate DBS surgery.
- •Subject had prior intracranial surgery or other implanted neurostimulators or drug delivery pumps.
- •Subject's life expectancy is less than one year.
- •Subject is Hoehn and Yahr stage 4-5 in the medication OFF condition.
- •Subject is pregnant or interested in becoming pregnant during the duration of the study.
- •Subject is currently enrolled in another clinical study utilizing investigational medications, devices, or treatment that would conflict with this protocol.
结局指标
主要结局
Measure Euclidean distance (mm) between the planned target coordinate and actual implanted coordinate
时间窗: 1 day
Compare the mean distance between the DBS planned target location to the actual implanted lead location for the SIS Group and Control Group
次要结局
未报告次要终点