Cathodal tDCS in Chronic Migraine: Neurophysiological Study and Pilot Therapeutic Trial

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

Detailed Description
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During the interictal phase, the cerebral cortex is characterised by a hyperresponsiveness to repeated sensory stimuli, manifested by a lack of habituation or adaptation of cortical responses. Lack of habituation has been shown in the visual cortex in studies of visual evoked potentials (VEP) during the interictal period and it is possibly explained by a reduction in the cortical pre-activation level due to thalamo-cortical dysrhythmia. Just before and during the migraine attack, cortical reactivity changes drastically: habituation is restored and the amplitude increases. In chronic migraine (headache occurring on 15 or more days per month for more than 3 months with features of migraine headache on at least 8 days per month), VEPs habituate normally like those recorded during attacks of episodic migraine, but have in addition an increased amplitude in the 1st block of responses. Chronic migraine was therefore compared to a never ending migraine attack accompanied by cortical hypersensitivity. In this study the investigators aim to demonstrate that cathodal tDCS over the visual cortex with simultaneous anodal tDCS over the left dorsolateral prefrontal cortex is able: 1) to reduce cortical hypersensitivity and habituation as assessed by VEPs and contact heat evoked nociceptive potentials (CHEPS), as well as to decrease pain perception assessed by quantitative sensory testing (QST) and the nociceptive blink reflex (nBR); 2) to decrease headache and migraine frequency.

Official Title
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Cathodal Transcranial Direct Current Stimulation in Chronic Migraine: Neurophysiological Study and Pilot Therapeutic Trial

Conditions
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Chronic Migraine

Intervention / Treatment
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* Device: Cefaly tDCS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of chronic migraine (ICHD III beta 1.3) with or without medication overuse Exclusion Criteria: 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cathodal Cefaly tDCS<br>Cathodal Cefaly tDCS is delivered over the visual cortex at 2 mA of intensity, for 20 minutes, everyday for 2 months, in 14 patients. The anode is placed over the left DLPFC. | Device: Cefaly tDCS<br>* Cefaly tDCS (transcranial direct current stimulation) is able to modify cortical excitability, in particular cathodal tDCS decreases 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 migraine frequency at baseline, 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 | 
| Scores at psychological scales | The investigators evaluate scores at psychological scales at baseline, during the treatment and 2 months after its end. | 6 months |