Repetitive Transcranial Magnetic Stimulation for the Prevention Treatment of Chronic Migraine: a Single Arm Study
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 主要终点
- 50% reduction in the Number of Days with Headache
研究概览
简要总结
We design this pilot, single arm study to explore the safety and efficacy of repetitive transcranial magnetic stimulation (rTMS) for the treatment of chronic migraine. The hypothetical control group is pooled sham group in latest meta-analysis. We expect a significant improvement of the outcome measures during and after the treatment as compared to the hypothetical control group.
详细描述
After a 28-day prospective baseline period using a headache diary to record headache symptoms and any abortive medications used, subjects who meet diagnostic criteria for chronic migraine and don't meet the exclusion criteria will receive rTMS for 4 weeks. The outcome measure will be evaluated at 4 weeks. During the whole trial period, any adverse events are requested to be recorded in the headache diary for analyses. The primary outcome is 50% reduction in the number of days with headache. 50% reduction as assessed by migraine days, moderate/severe headache days, the mean VRS, and conversion to episodic migraine, SGIC, the change from baseline HALT-28, HIT-6, and MSQ v2.1, are used as secondary outcome measures for exploring other benefits associated with treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Subjects meeting the diagnostic criteria for chronic migraine according to the International Classification of Headache Disorders, 3rd edition.
- •The duration of chronic migraine ≥ 6 months.
- •age range of 18 - 65 years old
排除标准
- •Secondary headaches except MOH
- •any change of the prophylaxis or the analgesic drug strategy during the baseline and follow-up period
- •structural brain lesions
- •severe systemic disease
- •TMS contraindications (such as metal implants)
- •psychosis
- •severe depression or anxiety
- •drug or alcohol dependence
- •pregnancy
- •participating in other experiments at the same time
研究组 & 干预措施
rTMS group
干预措施: rTMS (Device)
结局指标
主要结局
50% reduction in the Number of Days with Headache
时间窗: at 4 weeks
A Headache day is defined as a day with a headache that lasts at least 4 hours.
次要结局
- 50% reduction in the Number of Moderate/Severe Headache Days(at 4 weeks)
- The Subject's Global Impression of Change (SGIC)(at 4 weeks)
- Change from Baseline HALT-28 (Headache-Attributed Lost Time - 28 days)(at baseline and 4 weeks)
- 50% reduction as assessed by the mean VRS(at 4 weeks)
- 50% reduction in the Number of Migraine Days(at 4 weeks)
- Conversion to episodic migraine(at 4 weeks)
- Change from Baseline HIT-6 (Headache Impact Test-6)(at baseline and 4 weeks)
- Change from Baseline MSQ v2.1 (the Migraine-Specific Quality of Life questionnaire v2.1)(at baseline and 4 weeks)