NCT03062514Unknown不适用
Vagus Nerve Stimulation for Pediatric Intractable Epilepsy (VNS-PIE)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Changes in seizure frequency
研究概览
简要总结
Children with refractory epilepsy who are candidates for a treatment with vagus nerve stimulation will be prospectively randomized into 2 arms. Vagus nerve stimulation parameters are programmed and adjusted during outpatient clinic visits, within the normal clinical practice.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 6 seizure per month
- •Refractory Epilepsy
- •In good health except epilepsy
- •Patients or his(her) familyscould understand this method and sign the informed consent
- •Patients with good compliance and could complete postoperative follow-up
排除标准
- •Results of MRI remind epilepsy caused by intracranial space-occupying lesions
- •The vagus nerve lesion and damage
- •Tumor, cardiopulmonary anomaly, progressive neurological diseases, asthma，mental disease，pepticulcer，diabetes，bad health etc, and other surgical contraindication
- •Cann't write the epilepsy diary
- •Participating other clinical trial
- •Cann't complate the operation
- •Complete the postoperative follow-up
- •Cann't complete the promgramming
研究组 & 干预措施
Experimental
Experimental
Subjects'Vagus Nerve stimulator is on always
干预措施: PINS Vagus Nerve Stimualtor (Device)
Control
Sham Comparator
Subjects'Vagus Nerve stimulator is off from enrollment to 3 month
干预措施: PINS Vagus Nerve Stimualtor (Device)
结局指标
主要结局
Changes in seizure frequency
时间窗: 12 weeks of stimulation
次要结局
- GESELL mental development scales(12、24 weeks of stimulation)
- Changes in seizure frequency(6、12、24 weeks of stimulation)
- Engel scale description(6、12、24 weeks of stimulation)
- Changes in the Number of Anti-epileptic Drugs(6、12、24 weeks of stimulation)
研究者
研究点 (1)
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