Effects of Transcranial Direct Current Stimulation in Refractory Chronic Migraine and Medication-overuse Headache

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the efficacy of the transcranial direct current stimulation of the primary motor cortex (M1) in patients affected by refractory chronic migraine (coded as 1.5.1 in the international headache classification 2nd edition, 2004) and medication-overuse headache (coded as 8.1) with migraine as primary headache.

Official Title
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Randomized Double-Blind Sham-Controlled Study of the Effects of Transcranial Direct Current Stimulation in Refractory Chronic Migraine and Medication-overuse Headache Patients

Conditions
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Chronic Migraine, Medication Overuse Headache

Intervention / Treatment
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* Device: Anodal transcranial direct current stimulation
* Device: Sham transcranial direct current stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic MIgraine or Medication Overuse Headache according to the diagnostic criteria set out in the 2nd edition of the International Classification of Headache Disorders refractory to treatment according to the Refractory Headache Special Interest Section of the American Headache Society (Schulman et al., 2008) Exclusion Criteria: Other primary or secondary headaches. Any serious systemic or neurological disease or psychiatric disorder. Pregnancy or breastfeeding Previous or current use of other or similar devices for pain control Heart conduction and rhythm disorders Cranial surgery Other pain conditions, accordingly with current guidelines

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anodal transcranial direct current stimulation<br>Anodal transcranial direct current stimulation | Device: Anodal transcranial direct current stimulation<br> <br> * Other names: Transcranial direct current stimulator HDCstim, Newronika s.r.l., Milan, Italy;|
| Sham Comparator: Sham transcranial direct current stimulation<br>Sham transcranial direct current stimulation | Device: Sham transcranial direct current stimulation<br> <br> * Other names: Transcranial direct current stimulator HDCstim, Newronika s.r.l., Milan, Italy;|
| No Intervention: Control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in headache days per months |  | at 30, 60 and 90 days after the treatment | 
| Change in drugs intake per months |  | at 30, 60 and 90 days after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean pain intensity score per months |  | at 30, 60 and 90 days after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Migraine, Medication Overuse Headache, Refractory, transcranial direct current stimulation