Anodal Transcranial Direct Current Stimulation of the Visual Cortex Versus Sham Stimulation in the Episodic Migraine (ANODEM)
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|ClinicalTrials.gov Identifier: NCT02122757|
Recruitment Status : Withdrawn
First Posted : April 25, 2014
Last Update Posted : August 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Sporadic Migraine||Device: Cefaly tDCS Device: sham Cefaly tDCS||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Randomised Sham-controlled Trial of Anodal Transcranial Direct Current Stimulation (tDCS) for the Prevention of Episodic Migraine|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||September 2015|
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.
- Migraine frequency [ Time Frame: 6 months ]The investigators evaluate the migraine frequency at baseline (2 months), during the treatment and 2 months after its end.
- Migraine intensity [ Time Frame: 6 months ]The investigators evaluate migraine intensity at baseline, during the treatment and 2 months after its end.
- Acute medication intake [ Time Frame: 6 months ]The investigators evaluate acute medication intake at baseline, during the treatment and 2 months after its end.
- Attack duration [ Time Frame: 6 months ]The investigators evaluate attack duration at baseline, during the treatment and 2 months after its end.
- Score on psychological scales [ Time Frame: 6 Months ]The investigators evaluate score on psychological scales at baseline, during the treatment and 2 months after its end.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02122757
|Liege, Belgium, 4000|
|Principal Investigator:||Delphine Magis, MD,PhD||University of Liege|
|Study Director:||Jean Schoenen, MD,PhD||University of Liege|