NCT02378792Unknown早期 1 期
The Clinical Research on TsingHua Vagus Nerve Stimualtor for Treatment of Refractory Epilepsy
适应症
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 300
- 试验地点
- 5
- 主要终点
- Changes in seizure frequency from baseline to the seizure count evaluvation period 6 month
研究概览
简要总结
Evaluate the long-term clinical effectiveness and safety of the PINS vagus nerve stimulator to patients with refractory 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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having tried at least two appropriate anti-epileptic drugs (AEDs) tested to tolerance or to blood levels at upper end of the target range of which at least 2 have been tolerated at normal dose.
- •At least 1 seizure per month.
- •In good health except epilepsy.
- •With normal MMSE score
- •Patients or his(her) familyscould understand this method and sign the informed consent 7）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 Type 1，bad health etc, and other surgical contraindication
- •Alcohol addiction, smoking, and sleep-related breathing disorders
结局指标
主要结局
Changes in seizure frequency from baseline to the seizure count evaluvation period 6 month
时间窗: 4,8,12,16,20,24 months of stimulation
次要结局
- Changes from Basline in the Engel and McHugh description(At 12,24 months)
- Changes from Basline in 24 hour ECG description(At 12,24 months)
- Changes in seizure frequency from baseline to the seizure count evaluvation period(4,8,12,16,20,24 months of stimulation)
- Overall Quality of Life in Epilepsy-31 (QOLIE-31) Score in Patients With Baseline & at Least One Post-baseline QOLIE Assessment(Mean change from baseline QOLIE-31 Overall Score at 12,24 months)
- Changes in the Number of Anti-epileptic Drugs Prescribed(At12,24 months)
研究者
研究点 (5)
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