NCT01839396已完成不适用
Implantable Neurostimulator for the Treatment of Parkinson's Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 313
- 试验地点
- 43
- 主要终点
- Change in ON Time as Measured by Parkinson's Disease Diary
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of Boston Scientific's Vercise Deep Brain Stimulation (DBS) system in the treatment of patients with with advanced, levodopa-responsive bilateral Parkinson's disease (PD) which is not adequately controlled with medication.
详细描述
The study is multi-center, prospective, double-blind, randomized (3:1) controlled trial.
GUIDE XT may be used for planning of programming as needed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of bilateral idiopathic PD (H&Y ≥ 2) with a duration of PD ≥ 5 years.
- •Persistent disabling Parkinson's disease symptoms or drug side effects (e.g., dyskinesias, motor fluctuations, or disabling "off" periods) despite optimal medical therapy.
- •Able to understand the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.
排除标准
- •Any intracranial abnormality or medical condition that would contraindicate DBS surgery.
- •Have any significant psychiatric condition likely to compromise the subject's ability to comply with requirements of the study protocol
- •Any other active implanted devices including neurostimulators and /or drug delivery pumps
- •Any previous thalamotomy, pallidotomy or subjects who have undergone a DBS procedure.
- •Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints.
- •A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception.
结局指标
主要结局
Change in ON Time as Measured by Parkinson's Disease Diary
时间窗: From baseline to 12 weeks post-randomization
Difference in the mean change from baseline to 12 weeks post-randomization between the active and control groups in the ON time as measured by Parkinson's diary. Positive indicates improvement
次要结局
- Secondary Endpoints(From baseline to 12 weeks post-randomization)
研究者
研究点 (43)
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