Transcutaneous Supraorbital Nerve Stimulator Versus Topiramate in Prevention of Recurrent Migraine: A Prospective, Randomized Comparative Study.
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- 50% responder rate
研究概览
简要总结
Migraine has been ranked as the second most disabling neurological disorder in the worldwide. Medication or nonpharmacological treatments are all reasonable options for the prevention. Oral topiramate treatment is a typical effective method, while transcutaneous supraorbital nerve stimulation (SNS) was reported to be valuable for migraine acute treatment and even the prevention. As a new nonpharmacological therapeutic method, whether SNS is equivalent to topiramate is still unknown. The aim of the present study was to compare their effects in a cohort of migraine patients. After diagnosed with recurrent or chronic migraine and consented to this research, patients received randomly treatments by either SNS or topiramate, and were followed up prospectively. After a 1-month period of baseline observation, patients were followed by a 1-month treatment, and next 2-month period of followup. At least the following assessments will be performed: (1) Change from baseline in the number of migraine days during the 3 observing months; (2) Change from baseline in the number of moderate/ severe headache days over the 3 observing months; (3) 50% responder rate for the reduction of migraine days (percentage of patients having at least 50% reduction of migraine days) during the first treating month. Comparison of outcome measures between the 2 treatment groups will be performed to show the equivalence of SNS versus topiramate.
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 (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-60 years old;
- •Diagnosed with definite migraine (ICHD-3 code 1.1 or 1.2);
- •At least 2 migraine attacks per month during the past 3 months;
- •Consent to participate in the study;
- •No contraindications to associated treatments.
排除标准
- •Received preventive treatments during the previous 3 months;
- •Definite other kinds of headache, especially tension-type, medication overuse and secondary headache (ICHD-3 code 8.2);
- •Severe neurological or psychiatric disorders;
- •Severe primary systemic disorders including heart, brain, liver, kidney, and hematopoietic system;
- •Women with pregnancy or lactation.
研究组 & 干预措施
Topiramate
干预措施: Topiramate 25Mg Tab (Drug)
Transcutaneous Supraorbital Nerve Stimulator
干预措施: Transcutaneous Supraorbital Nerve Stimulator (Device)
结局指标
主要结局
50% responder rate
时间窗: during the first treating 1 month
50% responder rate for the reduction of migraine days (percentage of patients having at least 50% reduction of migraine days) during the first treating month
moderate/ severe headache days
时间窗: over the 3 observing months
Change from baseline in the number of moderate/ severe headache days over the 3 observing months
migraine days
时间窗: during the 3 observing months
Change from baseline in the number of migraine days during the 3 observing months
次要结局
- Averaged migraine days(during the 3 observing months)
- migraine attacks(during the 3 observing months)
- Cumulative pain hours(during the 3 observing months)
- bothersome symptoms(during the 3 observing months)
- Migraine functional impact(during the 3 observing months)