Double-blind Randomized Clinical Trial of Transcranial Magnetic Stimulation in Chronic Migraine

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Double-blind Randomized Clinical Trial to Evaluate Safety and Efficacy of Repetitive Transcranial Magnetic Stimulation in the Preventive Treatment of Chronic Migraine

Conditions
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Chronic Migraine

Intervention / Treatment
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* Device: 10Hz active rTMS
* Device: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: chronic migraine according to the criteria of the International Headache Society no change in prophylactic medication in the past 3 months Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Comparator: Active rTMS<br>10Hz active rTMS delivered to the left dorsolateral prefrontal cortex | Device: 10Hz active rTMS<br>* 10Hz active rTMS delivered to the left dorsolateral prefrontal cortex<br>* Other names: Repetitive transcranial magnetic stimulation;|
| Placebo Comparator: Placebo<br>10Hz placebo rTMS delivered to the vertex | Device: Placebo<br>* 10Hz placebo rTMS delivered to the vertex<br>* Other names: Repetitive transcranial magnetic stimulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of days with pain per month |  | After all treatment sessions (total, 23 sessions within 60 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse effects |  | After all treatment sessions (total, 23 sessions within 60 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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migraine