NCT04577651已完成不适用
Study to Evaluate Boston Scientific Vercise Cartesia 16-contact Directional Lead (X/HX) With Deep Brain Stimulation (DBS) Systems for the Treatment of Parkinson's Disease (PD)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 14
- 主要终点
- Change in Motor Function
研究概览
简要总结
The purpose of the study is to document patient outcomes including effectiveness for Boston Scientific Corporation's Vercise Cartesia 16-contact Directional Lead(s) (X/HX) with Deep Brain Stimulation (DBS) systems for the treatment of Parkinson's Disease (PD).
详细描述
Subjects will receive Deep Brain Stimulation with a 16-contact Directional Lead to treat their Parkinson's Disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Candidate for DBS implant in the treatment of Parkinson's disease
- •Must be on stable anti-parkinsonian medications for 28 days prior to Informed Consent
- •Persistent disabling Parkinson's disease symptoms such as dyskinesias, motor fluctuations, or disabling "off" periods despite optimal medical therapy
- •Be willing and able to comply with all visits and study related procedures (e.g., using the remote control, charging system, etc.).
排除标准
- •Any intracranial abnormality or medical condition that would contraindicate DBS surgery
- •Have any significant psychiatric or cognitive condition likely to compromise the subject's ability to comply with requirements of the study protocol (e.g. bipolar, schizophrenia, mood disorder with psychotic features, cluster B personality disorders)
- •Any current drug or alcohol abuse, as determined by the investigator
- •Any history of recurrent or unprovoked seizures
结局指标
主要结局
Change in Motor Function
时间窗: 12 weeks post device-activation
Mean change in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating (MDS-UPDRS) Part III scores from Baseline in meds off condition to 12 weeks post device-activation in stim on/meds off condition. Range 0 - 108. Higher scores indicate worse function.
次要结局
- Change in Motor Function(52 weeks post device-activation)
- Change in Quality of Life(52 weeks post device-activation)
研究者
研究点 (14)
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