NCT02004340Unknown不适用
Transcutaneous Auricular Vagus Nerve Stimulation as a Complementary Treatment for Pediatric Epilepsy
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- frequency of epileptic seizures
研究概览
简要总结
The purpose of this study is to determine whether transcutaneous auricular vagus nerve stimulation as a complementary therapy is effective in the treatment of pediatric epilepsy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosed as epilepsy;
- •With age between 2-18 years old;
- •The number and dose of the medication was kept constant no less than eight weeks before intervention;
- •The patients or their guardians can count the frequency of the seizures and finish the study.
排除标准
- •The patient is receiving the VNS therapy;
- •Accompanied with progressive central nervous system diseases;
- •Have severe heart, liver ,kidney or blood diseases;
- •Be pregnant or having the schedule of pregnancy in the study period.
结局指标
主要结局
frequency of epileptic seizures
时间窗: Change from baseline at 8, 16, 24 weeks respectively in frequency of epileptic seizures
次要结局
- Number of participants with adverse events as a measure of safety and tolerability(participants will be followed for the duration of TVNS intervention, an expected average of 8 weeks")
研究者
Wei He
Associate Professor
China Academy of Chinese Medical Sciences
研究点 (2)
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