Randomised Double-blind Evaluation of the Prophylactic Efficacy of Transcranial Direct Current Stimulation (tDCS) in Chronic Migraine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 4
- 主要终点
- Comparison of the evolution of seizure frequency between the two groups
研究概览
简要总结
The purpose of this study is to determine whether TDCS is an effective prophylactic therapy of chronic migraine.
详细描述
Consenting patients will report on a book, all of their migraine attack for 1 month. Then they will be randomized to the active tDCS group or sham tDCS group. Patients will have one session of tDCS per day during the first week, then one session per week for a month and finally a session every 15 days for 1 month. After tDCS sessions, patients will be followed for 3 months. Throughout their participation in the study, patients will complete their migraine record (1month of base line before tDCS, 2 months during tDCS, 3 months after tDCS).
Patients will have 5 evaluation examinations:
- The first, one before tDCS,
- The second, 1 month after the beginning of tDCS
- The third, immediately after the end of tDCS
- The fourth, 1 month after the end of tDCS
- And the last one, 3 months after the end of tDCS.
The physician responsible for conducting tDCS sessions will make the randomization via a website.
The physician in charge of the evaluation examinations will don't know the allocated 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of chronic migraine for more than 1 year
- •Stable treatment since 1 month
- •Frequency of migraine crisis is above 8 per month during last month
- •chronic migraine that has not been improved over the previous year by at least 3 different prophylactic treatments recommended and well conducted
- •Patient agreeing not to try other migraine prophylactic treatment, throughout the study
- •Patient's written consent
排除标准
- •History of drug addiction, epilepsy, or severe head trauma with bone break
- •History of psychiatric illness (psychosis and severe cognitive disorders) may interfere with the proper conduct of the study
- •Presence of intracranial ferromagnetic material or an implanted stimulator
- •Introduction of a new treatment for less than a month
- •Pregnant women, parturient women, breast-feeding mother. Lack of effective contraception
- •Person not understanding the study protocol
结局指标
主要结局
Comparison of the evolution of seizure frequency between the two groups
时间窗: Evolution of seizure frequency since base line to 3 months after the end of tDCS
次要结局
- Comparison of the evolution of seizure severity between the two groups(Evolution of seizure severity since base line to 3 months after the end of tDCS)
- Comparison of the evolution of crisis treatment use between the two groups(Evolution of crisis treatment use since base line until 3 months after the end of tDCS)
- Comparison of the evolution of the disease impact between the two groups(Evolution of the disease impact since base line to 3 months after the end of tDCS)
- Comparison of the evolution of the patient satisfaction between the two groups(Evolution of the patient satisfaction since base line to 3 months after the end of tDCS)
- Comparison of the evolution of the quality of life between the two groups(Evolution of the quality of life since base line until 3 months after the end of tDCS)
- Comparison of the evolution of anxiety and depression levels between the two groups(Evolution of anxiety and depression levels since base line until 3 months after the end of tDCS)