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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham Anodal Cefaly tDCS | Placebo Comparator | 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 |
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| Anodal Cefaly tDCS | Active Comparator | 2 mA anodal tDCS is delivered over the visual cortex, for 20 minutes, everyday for 2 months, in 15 patients. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cefaly tDCS | Device | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Delphine Magis, MD,PhD | University of Liege | Principal Investigator |
| Jean Schoenen, MD,PhD | University of Liege | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roberta Baschi | Liège | 4000 | Belgium |
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| sham Cefaly tDCS | Device | 2mA during 30sec |
|
| 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 |