NCT02632149Unknown早期 1 期
The Clinical Research on PINS Vagus Nerve Stimulator for Treatment of Lennox-Gastaut in Children
适应症
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 31
- 试验地点
- 5
- 主要终点
- Changes in seizure frequency from baseline to the seizure count evaluation period 6 month
研究概览
简要总结
The purpose of this study is to evaluate the clinical effectiveness of PINS vagus nerve stimulatior in children with Lennox-Gastaut Syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 3-14 year
- •Lennox - Gastaut syndrome diagnostic standard
- •Regular drug treatment is invalid
- •Antiepileptic drug stability in recent 3 months
- •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
- •Had epileptic foci excision surgery or corpus callosum
- •The vagus nerve lesion and damage
- •Tumor, cardiopulmonary anomaly, progressive neurological diseases, asthma， mental disease，peptic ulcer，diabetes Type 1，bad health etc, and other surgical contraindication
- •Participated in other clinical drug test subjects within three months
- •The researchers think that is not suitable for participants'
结局指标
主要结局
Changes in seizure frequency from baseline to the seizure count evaluation period 6 month
时间窗: 6 month of stimulation
次要结局
- Changes in seizure frequency from baseline to the seizure count evaluation period(1,3,6,months of stimulation)
- Change from Baseline in the Engel and McHugh description(At 1,3,6 months)
- Overall WISC Score in Patients from Baseline(Mean change from baseline WISC Overall Score at 1,3,6months)
研究者
研究点 (5)
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