NCT02603991Unknown不适用
Prospective Cohort Study on the Efficacy of Vagus Nerve Stimulation for Children and Adolescents With Epilepsy(PVNS-CAE)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- The change of the score in Quality of Life in Children with Epilepsy
研究概览
简要总结
Prospective cohort study on the long-term effectiveness and safety of PINS vagus nerve stimulators for children and adolescent with refractory epilepsy.
详细描述
Epileptic encephalopathy is very common in children and adolescent with epilepsy, but there is no data in clinical studies.The aim of this study is to evaluate the efficacy of the long-term vagus nerve stimulation for children and adolescent with epilepsy
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnostic criteria for epilepsia brain disorders
- •Having tried appropriate anti-epileptic drugs (AEDs) more than 1 year and zt least 6 seizures per month
- •patients or his(her) families could understand this method and sign the informed consent
- •Patients with good compliance and could complete postoperative follow-up
排除标准
- •the vagus nerve lesion and damage
- •patients with progressive neurological diseases, cardiopulmonary anomaly, respiratory system diseases,digestive system diseases
- •patients'mental state is not stable，
- •patients with or anesthesia contraindications,such as long-term use of anticoagulation antiplatelet drugs etc.
- •patients have or need other implantable devices, such as pacemakers,defibrillators, cochlear and spinal nerve root stimulator.
- •patients due to their own reasons for the need for nuclear magnetic resonance imaging in the future clinical trials
- •patients have participated in other clinical trials.
结局指标
主要结局
The change of the score in Quality of Life in Children with Epilepsy
时间窗: QOLCE Scores at 3,6,9,12,18, 24 month of stimulation
次要结局
- complication(complication at 3,6,9,12, 24 month)
- Respondent rate(Respondent rate at 3,6,9,12,24 month)
- seizure free rate(seizure free rate at 3,6,9,12, 24 month)
研究者
研究点 (1)
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