DRKS00003681已完成未知
Transcutaneous Vagus Nerve Stimulation for the treatment of chronic migraine - cMPsCMI01
cerbomed GmbH0 个研究点目标入组 46 人开始时间: 2012年3月23日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 46
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •males and females from 18 to 70 y. Patients suffering from chronic migraine according to ICHD-II 1.5.1. Duration of disease of minimum 3 months. Prophylactic medication on a stable regimen for minimum 1 month or 5 half-lives (the longer duration will be counted). Stable agent(s) for acute medication during baseline period. Patient diary kept properly for minimum 20 out of 28 days, minimum 15 headache days with minimum 4 hours of headache, extrapolation to 28 days.
排除标准
- •Participation in another clinical trial during the last 4 weeks before study entry. Pregnant or breastfeeding women. Suffering from craniomandibular dysfunction or fibromyalgia. Other primary/secondary headache disorders (e.g. cluster headache, trigeminal neuralgia, etc.). Beck depression inventory > 24 at date of inclusion. Other chronic neurological or psychiatric disorders (e.g. psychoses) which impair study participation. Dependance on opioids or benzodiazepines. Anatomical or pathological abnormalities at the left ear. Actual process of retirement.
研究者
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