Transcranial Direct Current Simulation in Chronic Migraine

Study Overview
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Brief Summary
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This study is a pilot, double-blind, placebo-controlled, randomized trial aiming to compare the effects of transcranial direct current stimulation in Chronic Migraine.

Detailed Description
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The patients will be randomized into 1 of 3 groups: active tDCS over primary motor cortex, active tDCS over prefrontal cortex, sham tDCS. Each group will receive treatment for 20 minutes a day, 3 days a week for 4 weeks.

Official Title
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Transcranial Direct Current Simulation Over Primary Motor vs Prefrontal Cortex in Chronic Migraine: a Pilot Randomized Controlled Trial

Conditions
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Migraine Disorders

Intervention / Treatment
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* Device: TDCS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with a clinical diagnosis of chronic migraine according to the International Classification of Headaches Disorders (ICHD-3 beta) of the International Headache Society, with an established headache history occurring on 15 or more days per month-however, for at least 1 year, instead of only 3 months, as defined in the International Headache Society (IHS) guidelines. Exclusion Criteria: headache attributable to some pathological condition, associated neurologic or neuropsychiatric disease, use of central nervous system modulating drugs, pregnancy, metallic head implants, and use of a cardiac pacemaker.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: active tDCS over primary motor cortex<br>Duration: 20 minutes; Intensity: 2 mA; Placement: left primary motor cortex. | Device: TDCS<br> <br> * Other names: Transcranial Direct Current Stimulation;|
| Experimental: active tDCS over prefrontal cortex<br>Duration: 20 minutes; Intensity: 2 mA; Placement: left prefrontal cortex. | Device: TDCS<br> <br> * Other names: Transcranial Direct Current Stimulation;|
| Placebo Comparator: sham tDCS over primary motor cortex<br>Duration: 20 minutes; The procedure is the same as for active tDCS, but the in the placebo tDCS the stimulation is non-active / sham; Placement: left primary motor cortex. | Device: TDCS<br> <br> * Other names: Transcranial Direct Current Stimulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of life associate to migraine assessed on the Headache Impact Test-6 (HIT-6) |  | Baseline (week 1) and Endpoint (week 4) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain assessed on the Visual Analogue Scale (VAS) |  | Baseline (week 1) and Endpoint (week 4) | 
| Change in quality of life assessed on the Medical Outcomes Study 36 - Item Short - Form Health Survey(SF-36) |  | Baseline (week 1) and and Endpoint (week 4) | 
| Side Effects Questionnaire |  | From date of first neurostimulation until the date of last neurostimulation, , assessed up to 1 month |