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

Randomised Sham-controlled Trial of Anodal Transcranial Direct Current Stimulation (tDCS) for the Prevention of Episodic Migraine

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

Study Overview

• Status: Withdrawn
• Conditions: Sporadic Migraine
• Intervention / Treatment: Device: Cefaly tDCS; Device: sham Cefaly tDCS

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Liege, Belgium, 4000
    • Roberta Baschi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: 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	Device: sham Cefaly tDCS; 2mA during 30sec
ACTIVE_COMPARATOR: Anodal Cefaly tDCS; 2 mA anodal tDCS is delivered over the visual cortex, for 20 minutes, everyday for 2 months, in 15 patients.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

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
Score on psychological scales	The investigators evaluate score on psychological scales at baseline, during the treatment and 2 months after its end.	6 Months

Collaborators and Investigators

• Sponsor: University of Liege

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (ACTUAL): September 1, 2015
• Study Completion (ACTUAL): September 1, 2015

Study Registration Dates

• First Submitted: November 4, 2013
• First Submitted That Met QC Criteria: April 22, 2014
• First Posted (ESTIMATE): April 25, 2014

Study Record Updates

• Last Update Posted (ACTUAL): August 18, 2020
• Last Update Submitted That Met QC Criteria: August 15, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: CB-1300