NCT01752439Unknown不适用
Randomized Double-Blind Sham-Controlled Study of the Effects of Transcranial Direct Current Stimulation in Refractory Chronic Migraine and Medication-overuse Headache Patients
Dr Armando Perrotta, MD, PhD0 个研究点目标入组 30 人开始时间: 2013年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 主要终点
- Change in headache days per months
研究概览
简要总结
The purpose of the study is to evaluate the efficacy of the transcranial direct current stimulation of the primary motor cortex (M1) in patients affected by refractory chronic migraine (coded as 1.5.1 in the international headache classification 2nd edition, 2004) and medication-overuse headache (coded as 8.1) with migraine as primary headache.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic MIgraine or Medication Overuse Headache according to the diagnostic criteria set out in the 2nd edition of the International Classification of Headache Disorders refractory to treatment according to the Refractory Headache Special Interest Section of the American Headache Society (Schulman et al., 2008)
排除标准
- •Other primary or secondary headaches.
- •Any serious systemic or neurological disease or psychiatric disorder.
- •Pregnancy or breastfeeding
- •Previous or current use of other or similar devices for pain control
- •Heart conduction and rhythm disorders
- •Cranial surgery
- •Other pain conditions, accordingly with current guidelines
结局指标
主要结局
Change in headache days per months
时间窗: at 30, 60 and 90 days after the treatment
Change in drugs intake per months
时间窗: at 30, 60 and 90 days after treatment
次要结局
- Change in mean pain intensity score per months(at 30, 60 and 90 days after treatment)
研究者
Dr Armando Perrotta, MD, PhD
MD, PhD
Mediterranean Neurological Institute
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