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

NCT ID: NCT02122757

Last Updated: 2020-08-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2015-09-30

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.

Conditions

Sporadic Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Sham Anodal 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

Group Type: PLACEBO_COMPARATOR

sham Cefaly tDCS

Intervention Type: DEVICE

2mA during 30sec

Anodal Cefaly tDCS

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

Group Type: ACTIVE_COMPARATOR

Cefaly tDCS

Intervention Type: 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.

Interventions

Cefaly tDCS

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.

Intervention Type: DEVICE

sham Cefaly tDCS

2mA during 30sec

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Liege

OTHER

Sponsor Role: lead

Responsible Party

Jean Schoenen

Honorary Full Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Delphine Magis, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University of Liege

Jean Schoenen, MD,PhD

Role: STUDY_DIRECTOR

University of Liege

Locations

Roberta Baschi

Liège, , Belgium

Countries

Belgium

Other Identifiers

CB-1300

Identifier Type: -

Identifier Source: org_study_id