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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Recruitment Status : Withdrawn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
Sponsor:
Information provided by (Responsible Party):
Jean Schoenen, University of Liege

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.

Condition or disease Intervention/treatment Phase
Sporadic Migraine Device: Cefaly tDCS Device: sham Cefaly tDCS Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Migraine intensity [ Time Frame: 6 months ]
    The investigators evaluate migraine intensity at baseline, during the treatment and 2 months after its end.

  2. Acute medication intake [ Time Frame: 6 months ]
    The investigators evaluate acute medication intake at baseline, during the treatment and 2 months after its end.

  3. Attack duration [ Time Frame: 6 months ]
    The investigators evaluate attack duration at baseline, during the treatment and 2 months after its end.

  4. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

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


Locations
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Belgium
Roberta Baschi
Liege, Belgium, 4000
Sponsors and Collaborators
University of Liege
Investigators
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Principal Investigator: Delphine Magis, MD,PhD University of Liege
Study Director: Jean Schoenen, MD,PhD University of Liege
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Responsible Party: Jean Schoenen, Honorary Full Professor, University of Liege
ClinicalTrials.gov Identifier: NCT02122757    
Other Study ID Numbers: CB-1300
First Posted: April 25, 2014    Key Record Dates
Last Update Posted: August 18, 2020
Last Verified: August 2020
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases