NCT03556722已完成不适用
Effectiveness and Tolerability of Repetitive Transcranial Magnetic Stimulation For Preventive Treatment Of Episodic Migraine: A Single Centre, Randomised, Double-Blind, Sham-Controlled Phase 2 Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Change from baseline in mean monthly migraine days.
研究概览
简要总结
This study will assess the safety and efficacy of repetitive transcranial magnetic stimulation (rTMS) as new preventive treatment of migraine.
详细描述
Migraine patients according to International Headache Society criteria will be allocated randomly into two treatment arms. One group will receive active rTMS and another group will receive sham rTMS for treatment phase (5 sessions). Assessment will be made at baseline, month 1, month 2 and month 3 post-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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double blinded
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females aged 18 to 60 years of age.
- •Subjects fulfilling criteria for episodic migraine as per the Third Edition of The International Headache Society (ICHD-3) for at least 1 year.
- •Frequency of migraine attacks 2-8 times per month with less than 15 headache days per month for at least 3 months prior to screening.
- •Demonstrated compliance with the headache diary during the run-in period by entry of headache data on a minimum of 24/30 days (80% compliance).
- •A signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study including any known and potential risks and available alternative treatments.
排除标准
- •Patients with previous history of rTMS treatment.
- •Onset of headache at more than 50-year-old.
- •Headache with red flags symptoms that may suggest organic secondary headaches.
- •Pregnant or lactating women.
- •Patients with contraindications to TMS such as metallic implant and pacemaker based on the Screening 13-item Questionnaire for rTMS candidate.
- •Patients with medical conditions such severe hypertension, infections, malignancy, cardiovascular and cerebrovascular disease, epilepsy degenerative central nervous system diseases, renal failure, hepatic failure, bleeding diathesis and serious mental illness.
研究组 & 干预措施
repetitive Transcranial Magnetic Stimulation
Active Comparator
Magstim Rapid-2 (Whitland, Walsh, UK), 70mm Double Air Film Coil given on left dorsolateral prefrontal cortex for five sessions.
干预措施: Repetitive Transcranial Magnetic Stimulation. (Device)
Sham repetitive Transcranial Magnetic Stimulation
Sham Comparator
Magstim Rapid-2 (Whitland, Walsh, UK), 70mm Double Air Film Sham Coil given on left dorsolateral prefrontal cortex for five sessions.
干预措施: Sham rTMS (Device)
结局指标
主要结局
Change from baseline in mean monthly migraine days.
时间窗: Baseline and month 1, 2 and 3 post treatment
The mean monthly migraine days will be calculated using the monthly migraine days from each of the month of the double-blind treatment phase.
次要结局
- Proportion of subjects with at least a 50% reduction from baseline in mean monthly migraine days.(Baseline and month 1, 2 and 3 post treatment)
- The Pittsburgh Sleep Quality Index score changes in migraine in response to rTMS.(Baseline and at month 3 post treatment)
- Satisfaction measures of efficacy, tolerability, safety and expectations of rTMS among the participants.(At month 3 post treatment)
- Electroencephalography (EEG) pattern change in migraine patients in response to rTMS.(Baseline and at month 3 post treatment)
- Serum serotonin level in migraine patients in response to rTMS.(Baseline and at month 3 post treatment)
- Serum Calcitonin gene related peptide (CGRP) level in migraine patients in response to rTMS.(Baseline and at month 3 post treatment)
- The Migraine Specific Questionnaire (MSQ) version 2.1 score changes in migraine patients in response to r-TMS.(Baseline and at month 3 post treatment)
- The EQ-5D score changes in migraine patients in response to rTMS.(Baseline and at month 3 post treatment)
- The Depression Anxiety Stress Scale (DASS 21) score changes in migraine patients in response to rTMS.(Baseline and at month 3 post treatment)
- Transcranial Doppler (TCD) pattern changes in migraine patients in response to rTMS.(Baseline and at month 3 post treatment)
- Change from baseline in mean monthly migraine attacks.(Baseline and month 1, 2 and 3 post treatment)
- Frequency and severity of adverse events in response to rTMS.(During treatment and up until 1 month post treatment)
- The Migraine Disability Assessment Test (MIDAS) score changes in migraine patients in response to rTMS.(Baseline and at month 3 post treatment)
- The Food Frequency Questionnaire score in migraine patients(Baseline)
- The Global Physical Activity Questionnaire score change in migraine in response to rTMS.(Baseline and at month 3 post treatment)
- Serum beta-endorphin level changes in migraine patients in response to rTMS.(Baseline and at month 3 post treatment)
研究者
Wan Aliaa Wan Sulaiman
Associate Professor
Universiti Putra Malaysia
研究点 (1)
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