Randomised Placebo Controlled Trial of rTMS Quadri Pulse Over Visual Cortex for the Prevention of Chronic Migraine
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Frequency of migraine
研究概览
简要总结
Evaluation of inhibiting rTMS QP over the visual cortex for the prevention of chronic migraine. The aim of the study is to confirm that inhibiting rTMS QP is capable to decrease the frequency of migraine and if its effect is stronger than placebo effect.
详细描述
The investigators have already inquired if inhibiting rTMS QP over the visual cortex determines a reduction of frequency of migraine in a previous study. After 2 weekly sessions for a month, the investigators demonstrated a reduction of 47% in migraine frequency. In this study, the investigators aim to compare rTMS QP effect with the placebo effect and to evaluate if rTMS QP is capable to induce changes in VEP, CHEPS and QST.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- •diagnosis of chronic migraine (ICHD III beta 1.3) with or without medication overuse.
排除标准
- •other diseases or contraindication for the magnetic stimulation (epilepsy, pacemaker, metallic prothesis)
研究组 & 干预措施
Super Rapid Magstim Stimulator rTMS QP
rTMS QP is delivered over the visual cortex for 30 minutes, 2 times a week for 8 weeks, in 15 patients
干预措施: Super Rapid Magstim Stimulator (Device)
Placebo
rTMS QP placebo (coil perpendicular to the scalp) is delivered over the visual cortex for 30 minutes, 2 times a week for 8 weeks, in 15 patients.
干预措施: Super Rapid Magstim Stimulator (sham) (Device)
结局指标
主要结局
Frequency of migraine
时间窗: 12 months
The investigators evaluate the frequency of migraine during the treatment and 2 months after its end.
次要结局
- Intensity of migraine(12 months)
- Attack duration(12 months)
- Acute medication intake(12 months)
- Scores on psychological scales(12 months)
研究者
Jean Schoenen
Honorary Full Professor
University of Liege