NCT02835443已完成不适用
Electrical Stimulation of the Dentate Nucleus Area (EDEN) for Improvement of Upper Extremity Hemiparesis Due to Ischemic Stroke: A Safety and Feasibility Study
Enspire DBS Therapy, Inc.2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2016年10月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Adverse Events
研究概览
简要总结
This clinical trial will evaluate if Deep Brain Stimulation (DBS) is safe for the treatment of stroke and will help understand if DBS improves motor recovery for patients who continue to have significant impairment.
详细描述
The proposed study is a safety and feasibility study intended to provide preliminary data to design a future pilot study. The objective of this study is to document the safety and patient outcomes of electrical stimulation of the dentate nucleus area for the management of chronic, moderate to severe upper extremity hemiparesis due to ischemic stroke.
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
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •One-time stroke that occurred 1-3 years ago (i.e. index stroke 12-36 months)
- •Stroke due to a blocked blood vessel (i.e. unilateral MCA stroke)
- •Moderate to severe weakness in one arm (i.e. unilateral upper-extremity hemiparesis)
排除标准
- •Seizures since time of stroke (i.e. seizures or seizure disorder)
- •Unable to have an MRI (i.e. contraindicated for MRI)
结局指标
主要结局
Adverse Events
时间窗: 18 Months
Incidence of study-related serious adverse events
次要结局
未报告次要终点
研究者
研究点 (2)
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