NCT02402569终止早期 1 期
Implantation Feasibility Study of a Multi-electrodes Set for Deep Brain Stimulation in Parkinson Disease (Smart in Vivo 2)
University Hospital, Grenoble2 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2014年12月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Safety, as measured by Number of Participants with Adverse Events
研究概览
简要总结
This study aims to demonstrate innocuity and feasibility of deep brain stimulation with a multi-electrodes set.
详细描述
Bilateral stimulation in subthalamic nucleus with the multi-electrodes set will be compared with single electrode.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •more or equal than 18 years old and less than 70 years
- •patient affiliated to social security or similarly regime
- •informed consent form signed
- •parkinson disease (UPDRS III20 score up than 30/108 except for severe tremors)
- •motor and non motor dysfunctions
- •pre-operative cerebral MRI without lesion
- •without chirurgical contraindications
- •without psychiatric disease
排除标准
- •Pregnant women and lactating mothers
- •Ward of court or under guardianship
- •Adult unable to express their consent
- •Person deprived of freedom by judicial or administrative decision
- •Person hospitalized without their consent
- •Person under legal protection
- •Person with carcinological antecedent during precedent 5 years
- •Chirurgical or MRI contraindications
研究组 & 干预措施
Multi-electrodes / single electrode
Experimental
Multi stimulation / single stimulation
干预措施: 32 channels Deep Brain Stimulator (Device)
Single-electrode / Multi electrodes
Experimental
Single stimulation / Multi stimulation
干预措施: 32 channels Deep Brain Stimulator (Device)
结局指标
主要结局
Safety, as measured by Number of Participants with Adverse Events
时间窗: 3 months
Number of Participants with Adverse Events
次要结局
- Neurologic evaluation(3 months)
研究者
研究点 (2)
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