NCT01460771Unknown2 期
Pilot Open-label and Blinded Clinical Trial of Transcranial Direct-current Stimulation in Childhood Dystonia
适应症
干预措施
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Hand muscle overflow
研究概览
简要总结
The investigators hypothesize that transcranial direct current stimulation over the motor cortex will reduce muscle overflow and improve hand function in children with primary or secondary dystonia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •dystonia affecting one or both hands
- •age 4 to 21 years
排除标准
- •metal implants in the head
- •inability to cooperate with instructions
研究组 & 干预措施
Treatment
Experimental
Active Transcranial Direct Current Stimulation (TDCS) at 1mA or highest tolerated current
干预措施: TDCS (Transcranial Direct-current Stimulation) (Device)
sham
Sham Comparator
inactive Transcranial Direct current stimulation (TDCS) at 0mA
干预措施: sham TDCS (Transcranial Direct-current Stimulation) (Device)
结局指标
主要结局
Hand muscle overflow
时间窗: 10 minutes post- transcranial Direct-current Stimulation (TDCS)
surface EMG measure of overflow into muscles during attempted relaxation.
次要结局
未报告次要终点
研究者
Terence Sanger
Associate Professor
University of Southern California
研究点 (1)
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