Prospective Randomized Trial Comparing Different Stimulation Paradigms in Patients Treated With Vagus Nerve Stimulation for Refractory Epilepsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Efficacy of vagus nerve stimulation: responder rates and mean monthly seizure frequency reduction, mean seizure free interval, seizure severity and seizure type
研究概览
简要总结
Patients with refractory epilepsy who are candidates for a treatment with vagus nerve stimulation will be prospectively randomized into 3 arms with different vagus nerve stimulation paradigms. 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
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •16 years or older
- •At least 1 seizure/month with alteration of consciousness
- •Documented seizure diary, at least 3 months prior to implantation (baseline)
- •No change in anti-epileptic drugs 1 month before implantation
- •At least one or more AEDs
排除标准
- •Active cardiac, pulmonary or gastrointestinal disease
- •Concomitant use of an investigational drug
- •Unstable medical condition
- •Unstable psychiatric condition
研究组 & 干预措施
1
Vagus nerve stimulation paradigm #1
干预措施: Vagus nerve stimulation paradigm #1 (Procedure)
2
Vagus nerve stimulation paradigm #2
干预措施: Vagus nerve stimulation paradigm #2 (Procedure)
3
Vagus nerve stimulation paradigm #3
干预措施: Vagus nerve stimulation paradigm #3 (Procedure)
结局指标
主要结局
Efficacy of vagus nerve stimulation: responder rates and mean monthly seizure frequency reduction, mean seizure free interval, seizure severity and seizure type
时间窗: After 6 and 12 months
次要结局
- VNS-related side effects(After 6 and 12 months)
- Battery life(After 6 and 12 months)
- Mood assessment: changes in Beck depression scale scores(After 12 months)
- Quality of life: changes in QOLIE 89 score(After 12 months)