Evaluating Repetitive Transcranial Magnetic Stimulation for Refractory Chronic Cluster Headache Prevention: Insights From a Randomised Crossover Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Reduction in number of attacks per week
研究概览
简要总结
The goal of this clinical trial is to learn if drug ABC works to treat severe asthma in adults. It will also learn about the safety of drug ABC. The main questions it aims to answer are:
Does Transcranial Magnetic Stimulation lower the number of attacks per week in patients with refractory cluster headache ?
Researchers will compare transcranial magnetic stimlation to a sham stimulation (a look-alike stimulation) to see if it works to prevent attacks of cluster headache.
Participants will:
Recieve stimulation for 10 minutes for 10 consecutive working days in 2 periods of time, separated by a 1 month washout period.
Visit the clinic for each treatment day. Keep a diary of their symptoms and the number of times they use a rescue medication
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Diagnosed with Chronic Cluster Headache (CCH) based on the International Classification of Headache Disorders 3rd Edition
- •Diagnosed with refractory CCH based on the European Headache Federation criteria of 2014.
排除标准
- •History of epilepsy.
- •Concomitant diagnosis of any other headache (if the patient was unable to differentiate between them).
- •Carriers of any electronic device, or any additional contraindication for Transcranial Magnetic Stimulation, such as pregnancy.
研究组 & 干预措施
Sequence A
The study consisted of two treatment periods (rTMS and sham stimulation), separated by a one-month washout period, and organized into two sequences (A and B)
Sequence A:
rTMS → washout → sham.
Sequence B:
sham → washout → rTMS.
干预措施: Repetitive Transcranial Magnetic Stimulation (Device)
Sequence A
The study consisted of two treatment periods (rTMS and sham stimulation), separated by a one-month washout period, and organized into two sequences (A and B)
Sequence A:
rTMS → washout → sham.
Sequence B:
sham → washout → rTMS.
干预措施: Sham Stimulation (Device)
Sequence B
Sequence B:
sham → washout → rTMS.
干预措施: Repetitive Transcranial Magnetic Stimulation (Device)
Sequence B
Sequence B:
sham → washout → rTMS.
干预措施: Sham Stimulation (Device)
结局指标
主要结局
Reduction in number of attacks per week
时间窗: From enrollment to the end to follow up period, at 3 months after last treatment period (week 8)
The mean change in the number of attacks per week at the end of each treatment period was compared with the baseline, from the time of informed consent until the last follow-up moment (3 months after the end of the second treatment period).
次要结局
- Assessing the reduction in symptomatic medication use.(From enrollment to the end of follow up period, at 3 months after second treatment period (week 8))
- To assess the reduction in intensity of cluster headache attacks(From enrollment to the end of follow up period, at 3 months after second treatment period (week 8))
- To assess the tolerability to treatment(From enrollment to the end of follow up period, at 3 months after second treatment period (week 8))
- To assess the change in duration in cluster headache attacks(From enrollment to the end of follow up period, at 3 months after second treatment period (week 8))
研究者
Javier Díaz de Terán
PhD
Instituto de Investigación Hospital Universitario La Paz