NCT03780426已完成2 期
Transcranial Static Magnetic Field Stimulation (tSMS) in Essential Tremor
Fundación de investigación HM2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年10月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change from baseline in postural tremor amplitude in the hand contralateral to hemispheren that received tSMS treatment compared to the hand contralateral to the hemisphere that received sham treatment, as measured by accelerometry.
研究概览
简要总结
This is randomized double-blind study to study the hypothesis that transcranial static magnetic field stimulation of the primary motor cortex improves tremor in patients with essential tremor. Half of the patients will receive tSMS of the left hemisphere and the other half of the right hemisphere.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Essential tremor
排除标准
- •MRI-incompatible metal objects in the body (e.g. cardiac pacemakers)
- •other main neuropsychiatric co-morbidity
- •pregnancy
结局指标
主要结局
Change from baseline in postural tremor amplitude in the hand contralateral to hemispheren that received tSMS treatment compared to the hand contralateral to the hemisphere that received sham treatment, as measured by accelerometry.
时间窗: Immediately after treatment compared baseline
次要结局
- Change from baseline in tremor frequency, as measured by accelerometry.(Immediately after treatment and 15 minutes after treatment compared baseline.)
- Change from baseline in postural tremor amplitude 15 minutes after treatment, as measured by accelerometry.(15 minutes after treatment compared to baseline)
- Change from baseline in rest tremor amplitude, as measured by accelerometry.(Immediately after treatment and 15 minutes after treatment compared baseline.)
- Change from baseline in the Clinical Rating Scale for Tremor part B (drawing)(5 minutes after treatment and 20 minutes after treatment compared to baseline)
研究者
研究点 (2)
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