NCT02134795终止不适用
A Pilot Study of a Non-Invasive Neuromodulation Device for Treatment of Parkinson's Disease
Scion NeuroStim2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2014年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Motor UPDRS Score (Unified Parkinson's Disease Rating Scale)
研究概览
简要总结
This is a single-center, open label study evaluating the acute effect of caloric vestibular stimulation on UPDRS motor scores in Parkinson's Disease patients.
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
- •Patient should have a UPDRS motor score of 14 (off medication) or higher (mild to moderate)
- •Patient should have a Hoehn & Yahr staging of 1 to 3 (mild to moderate)
- •Patient must be an adult (18 years of age or older)
排除标准
- •Women who are pregnant or nursing
- •have a history of significant cardiovascular disease (no pacemakers)
- •have a history of unstable mood disorder or unstable anxiety disorder or psychosis
- •use a hearing aid
- •have a cochlear implant
- •have been diagnosed with neurological disease other than Parkinson's disease. No atypical parkinsonism.
- •have a diagnosed vestibular dysfunction
- •abuse alcohol or other drugs
- •have had eye surgery within the previous three months or ear surgery within the previous six months
- •have active ear infections or a perforated tympanic membrane
- •have participated in another clinical trial within the last 30 days or are currently enrolled in another clinical trial
结局指标
主要结局
Motor UPDRS Score (Unified Parkinson's Disease Rating Scale)
时间窗: Changes in motor score at 25, 50, 75, 100, 130, 160 and 220 minutes relative to baseline
A motor score prior to use of the device will be established (time zero), the motor test will be repeated after the first use of the device (times 25, 50, and 75 minutes), and then after a second use of the device (times 100, 130, 160 and 220). Any changes in motor scores at the various time points will be noted. A videotape of the motor UPDRS examination will be obtained at baseline and during the final test.
次要结局
未报告次要终点
研究者
研究点 (2)
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