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

University of Liege

Status: Withdrawn

Conditions: Sporadic Migraine

Treatments: Device: sham Cefaly tDCS; Device: Cefaly tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT02122757

CB-1300

Details and patient eligibility

About

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

Full description

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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

Sham Anodal Cefaly tDCS

Placebo Comparator group

Description:

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

Treatment:

Device: sham Cefaly tDCS

Anodal Cefaly tDCS

Active Comparator group

Description:

2 mA anodal tDCS is delivered over the visual cortex, for 20 minutes, everyday for 2 months, in 15 patients.

Treatment:

Device: Cefaly tDCS