Anodal Transcranial Direct Current Stimulation of the Visual Cortex Versus Sham Stimulation in the Episodic Migraine

Study Overview
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Brief Summary
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Anodal tDCS increases the excitability of the cerebral cortex and its daily application during intercritical phase, may have a therapeutic effect in episodic migraine.

Detailed Description
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During the interictal phase, the cerebral cortex is characterised by hyperresponsiveness to repeated sensory stimuli, manifested by a lack of habituation or adaptation of cortical evoked responses. Such habituation deficit can be shown in the visual cortex by the study of visual evoked potentials (VEP) and it is possibly explained by a reduction in the cortical pre-activation level due to thalamo-cortical dysrhythmia. In healthy subjects and in migraineurs between attacks, anodal tDCS increases VEP habituation and 1st block amplitude. In a proof-of-concept trial, the investigators have shown in 10 episodic migraine without aura patients that 2 weekly 15-minute sessions for 8 weeks of anodal tDCS over the visual cortex significantly decreased attack frequency, migraine days, attack duration and acute medication intake for more than 4 weeks after the last treatment session. This randomized trial was designed to prove the preventive effect in episodic migraine of anodal tDCS over the visual cortex compared to sham stimulation.

Official Title
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Randomised Sham-controlled Trial of Anodal Transcranial Direct Current Stimulation (tDCS) for the Prevention of Episodic Migraine

Conditions
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Sporadic Migraine

Intervention / Treatment
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* Device: Cefaly tDCS
* Device: sham Cefaly tDCS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of episodic migraine with (ICHD III beta 1.2.1) or without aura (ICHD III beta 1.1) Exclusion Criteria: preventive treatment others diseases or contraindications to tDCS (epilepsy, pacemaker, metal prosthetics)

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Sham Anodal Cefaly tDCS<br>2 mA placebo anodal tDCS (the direct current is delivered just for 30 seconds) is applied over the visual cortex for 20 minutes, everyday for 2 months, in 15 patients | Device: sham Cefaly tDCS<br>* 2mA during 30sec<br>|
| Active Comparator: Anodal Cefaly tDCS<br>2 mA anodal tDCS is delivered over the visual cortex, for 20 minutes, everyday for 2 months, in 15 patients. | Device: Cefaly tDCS<br>* Cefaly tDCS (transcranial direct current stimulation) is able to modify cortical excitability, in particular anodal tDCS increases it. The side effects of tDCS are minor, especially sensations of itching and scalp paresthesias.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Migraine frequency | The investigators evaluate the migraine frequency at baseline (2 months), during the treatment and 2 months after its end. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Migraine intensity | The investigators evaluate migraine intensity at baseline, during the treatment and 2 months after its end. | 6 months | 
| Acute medication intake | The investigators evaluate acute medication intake at baseline, during the treatment and 2 months after its end. | 6 months | 
| Attack duration | The investigators evaluate attack duration at baseline, during the treatment and 2 months after its end. | 6 months | 
| Score on psychological scales | The investigators evaluate score on psychological scales at baseline, during the treatment and 2 months after its end. | 6 Months |