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

Sporadic Migraine Clinical Trial

— ANODEM  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02122757
• Other study ID #: CB-1300
• Status: Withdrawn
• Phase: N/A
• Start date: September 2013
• Est. completion date: September 2015

Study information

• Verified date: August 2020
• Source: University of Liege
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Migraine Disorders
• Sporadic Migraine

Intervention

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.
• sham Cefaly tDCS
2mA during 30sec

Locations

Country	Name	City	State
Belgium	Roberta Baschi	Liege

Sponsors (1)

Lead Sponsor	Collaborator
University of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Migraine frequency	The investigators evaluate the migraine frequency at baseline (2 months), during the treatment and 2 months after its end.	6 months
Secondary	Migraine intensity	The investigators evaluate migraine intensity at baseline, during the treatment and 2 months after its end.	6 months
Secondary	Acute medication intake	The investigators evaluate acute medication intake at baseline, during the treatment and 2 months after its end.	6 months
Secondary	Attack duration	The investigators evaluate attack duration at baseline, during the treatment and 2 months after its end.	6 months
Secondary	Score on psychological scales	The investigators evaluate score on psychological scales at baseline, during the treatment and 2 months after its end.	6 Months