Double-blind Randomized Clinical Trial to Evaluate Safety and Efficacy of Repetitive Transcranial Magnetic Stimulation in the Preventive Treatment of Chronic Migraine
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- number of days with pain per month
研究概览
简要总结
The purpose of this study is to determine whether active repetitive transcranial magnetic stimulation of the left dorsolateral prefrontal cortex is safe and effective for preventive treatment of chronic migraine, compared to placebo repetitive transcranial magnetic stimulation.
详细描述
Patients with chronic migraine according to the criteria of the International Headache Society will be randomized to either active repetitive transcranial magnetic stimulation of the left dorsolateral prefrontal cortex or placebo repetitive transcranial magnetic stimulation, in a total of 23 sessions of treatment (15 sessions in the first month and 8 sessions in the second month of treatment). Outcomes will be evaluated at baseline, after one, two months after treatment, and one month after end of treatment
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic migraine according to the criteria of the International Headache Society
- •no change in prophylactic medication in the past 3 months
排除标准
- •other neurological disorders
- •bipolar disorder
- •alcohol or drug dependence in the past 2 months
- •suicidal ideation, psychotic symptoms
- •contraindications to transcranial magnetic stimulation (cardiac pacemaker, implanted electronic devices, metal in the skull, skull fractures, history of seizures)
- •use of antidepressants in the past 4 weeks
- •pregnancy or lack of birth-control method in women of childbearing age
研究组 & 干预措施
Active Comparator: Active rTMS
10Hz active rTMS delivered to the left dorsolateral prefrontal cortex
干预措施: 10Hz active rTMS (Device)
Placebo
10Hz placebo rTMS delivered to the vertex
干预措施: Placebo (Device)
结局指标
主要结局
number of days with pain per month
时间窗: After all treatment sessions (total, 23 sessions within 60 days)
次要结局
- adverse effects(After all treatment sessions (total, 23 sessions within 60 days))
研究者
Adriana Conforto
Professor of Neurology, MD PhD
Hospital Israelita Albert Einstein