Skip to content

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

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02122757
Acronym
ANODEM
Enrollment
0
Registered
2014-04-25
Start date
2013-09-30
Completion date
2015-09-30
Last updated
2020-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sporadic Migraine

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.

Interventions

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.

DEVICEsham Cefaly tDCS

2mA during 30sec

Sponsors

University of Liege
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Migraine frequency6 monthsThe investigators evaluate the migraine frequency at baseline (2 months), during the treatment and 2 months after its end.

Secondary

MeasureTime frameDescription
Migraine intensity6 monthsThe investigators evaluate migraine intensity at baseline, during the treatment and 2 months after its end.
Acute medication intake6 monthsThe investigators evaluate acute medication intake at baseline, during the treatment and 2 months after its end.
Attack duration6 monthsThe investigators evaluate attack duration at baseline, during the treatment and 2 months after its end.
Score on psychological scales6 MonthsThe investigators evaluate score on psychological scales at baseline, during the treatment and 2 months after its end.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026