NCT02263430Unknown不适用
PINS Stimulator System for Deep Brain Stimulation in Huntington's Disease
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 8
- 主要终点
- Unified Huntington's Disease Rating Scale(UHDRS)
研究概览
简要总结
Deep Brain Stimulation (DBS) of the Globus pallidus internus(GPi) is useful in the treatment of different forms of chorea, including Huntington's disease (HD).
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
- Double (Participant, Outcomes Assessor)
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 clinically symptomatic and genetically confirmed Huntington Disease (number of CAG repeats>= 36)
- •Moderate stage of the disease (UHDRS motor>= 30)
- •Predominant movement disorder
- •Compliance of the patient, stable cognition during a 6 months phase prior to inclusion (Mattis Dementia Rating Scales（MDS）>/= 120)
- •Signed informed consent.
排除标准
- •Patients with hearing impairment;
- •Failures of important organs and in severe conditions;
- •Be reluctant or disabled to receive neuropsychological assessments;
- •Participate in other clinical trial;
- •Has a life expectancy of < 1 year.
- •The investigator and/or enrollment review committee, would preclude participation in the study.
结局指标
主要结局
Unified Huntington's Disease Rating Scale(UHDRS)
时间窗: 12 month
次要结局
未报告次要终点
研究者
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