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

Not Applicable

Withdrawn

• Conditions: Sporadic Migraine
• Interventions: Device: sham Cefaly tDCS; Device: Cefaly tDCS

• Registration Number: NCT02122757
• Lead Sponsor: University of Liege

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-11-04
• Study First Submitted QC: 2014-04-22
• Study First Posted: 2014-04-25
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-15
• Last Update Posted: 2020-08-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Anodal Cefaly tDCS	sham Cefaly tDCS	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
Anodal Cefaly tDCS	Cefaly tDCS	2 mA anodal tDCS is delivered over the visual cortex, for 20 minutes, everyday for 2 months, in 15 patients.

Primary Outcome Measures

Name	Time	Method
Migraine frequency	6 months	The investigators evaluate the migraine frequency at baseline (2 months), during the treatment and 2 months after its end.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Roberta Baschi; 🇧🇪 Liege, Belgium