NCT01978080已完成不适用
ETSense: Adaptive Portable Essential Tremor Monitor - Symptomatic Impact Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 4
- 主要终点
- Clinical Global Impression-Change Scale score
研究概览
简要总结
The specific aim of this study is to evaluate if tremor severity and quality of life can be improved more using continuous home monitoring along with traditional assessments versus traditional assessments alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with essential tremor
- •Currently taking medication to control tremor
排除标准
- •Cognitive limitations that prevent comprehension or execution of study protocol
结局指标
主要结局
Clinical Global Impression-Change Scale score
时间窗: End of Month 1, End of Month 2, End of Month 3
Utilized to measure any improvement or worsening of symptoms relative to a baseline state at enrollment
次要结局
- Clinical Global Impression-Severity Scale Score(Enrollment, End of Month 1, End of Month 2, End of Month 3)
- Washington Heights Inwood Genetic Study of Essential Tremor (WHIGET) Tremor Rating Scale(Enrollment, End of Month 1, End of Month 2, End of Month 3)
- Quality of Life in Essential Tremor Questionnaire(Enrollment, End of Month 1, End of Month 2, End of Month 3)
研究者
研究点 (4)
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