rTMS for the Prevention Treatment of CM: a Single Arm Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Repetitive Transcranial Magnetic Stimulation for the Prevention Treatment of Chronic Migraine: a Single Arm Study

Conditions
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Chronic Migraine

Intervention / Treatment
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* Device: rTMS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Secondary headaches except MOH any change of the prophylaxis or the analgesic drug strategy during the baseline and follow-up period structural brain lesions seizures 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rTMS group<br> | Device: rTMS<br>* The subjects will receive 20 trains of 100 stimuli each delivered at 10 Hz and 80% of MT over the left MC (M1), 3 days a week, for 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 50% reduction in the Number of Days with Headache | A Headache day is defined as a day with a headache that lasts at least 4 hours. | at 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 50% reduction in the Number of Migraine Days | A migraine day is defined as a day with a headache that lasts at least 4 hours; meets ICHD-III criteria C and D for migraine without aura (1.1), B and C for migraine with aura (1.2), or ICHD-III criteria for probable migraine (1.6); or a day with a headache that is successfully treated with a triptan, ergotamine, or other migraine-specific acute medication. | at 4 weeks | 
| 50% reduction in the Number of Moderate/Severe Headache Days | A moderate/severe headache day is defined as a day with moderate or severe pain that lasts at least 4 hours or a day with a headache that is successfully treated by an acute headache medication. | at 4 weeks | 
| Conversion to episodic migraine | Defined as the proportion of subjects with fewer than 14 migraine or headache days per 4 weeks. | at 4 weeks | 
| The Subject's Global Impression of Change (SGIC) | Global impression of change was scored using a 7-point scale for each instrument, ranging from 1 (very much improved) to 7 (very much worse), with a 4-week recall period. We'll estimate the proportion of patients who reported any improved (very much improved, much improved, minimally improved). | at 4 weeks | 
| Change from Baseline HALT-28 (Headache-Attributed Lost Time - 28 days) | HALT-30 is closely based on the first five questions of MIDAS, developed by RB Lipton and WF Stewart. We modify the time interval to capture migraine-related disability with a 4-week recall period. | at baseline and 4 weeks | 
| Change from Baseline HIT-6 (Headache Impact Test-6) | HIT-6 is for capturing migraine-related disability with a 4-week recall period. | at baseline and 4 weeks | 
| Change from Baseline MSQ v2.1 (the Migraine-Specific Quality of Life questionnaire v2.1) | To evaluate the change in quality of life related to chronic migraine with a 4-week recall period. | at baseline and 4 weeks | 
| 50% reduction as assessed by the mean VRS | Subjects will be instructed to record the pain intensity of each day using 11-point Visual Rating Scale (VRS). The mean VRS is defined as the mean of the maximum VRS of each day with a 4-week period. | at 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment Outcome, Brain, Transcranial Magnetic Stimulation, Migraine Disorders, Prophylaxis