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Cathodal tDCS in Chronic Migraine: Neurophysiological Study and Pilot Therapeutic Trial (CATCHROMIG)

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ClinicalTrials.gov Identifier: NCT02122237
Recruitment Status : Completed
First Posted : April 24, 2014
Last Update Posted : May 28, 2015
Sponsor:
Information provided by (Responsible Party):
Jean Schoenen, University of Liege

Brief Summary:
Cathodal tDCS decreases the excitability of the cerebral cortex and its daily application during intercritical phase, may have a therapeutic effect in chronic migraine.

Condition or disease Intervention/treatment Phase
Chronic Migraine Device: Cefaly tDCS Phase 3

Detailed Description:

During the interictal phase, the cerebral cortex is characterised by a hyperresponsiveness to repeated sensory stimuli, manifested by a lack of habituation or adaptation of cortical responses. Lack of habituation has been shown in the visual cortex in studies of visual evoked potentials (VEP) during the interictal period and it is possibly explained by a reduction in the cortical pre-activation level due to thalamo-cortical dysrhythmia. Just before and during the migraine attack, cortical reactivity changes drastically: habituation is restored and the amplitude increases. In chronic migraine (headache occurring on 15 or more days per month for more than 3 months with features of migraine headache on at least 8 days per month), VEPs habituate normally like those recorded during attacks of episodic migraine, but have in addition an increased amplitude in the 1st block of responses. Chronic migraine was therefore compared to a "never ending migraine attack" accompanied by cortical hypersensitivity.

In this study the investigators aim to demonstrate that cathodal tDCS over the visual cortex with simultaneous anodal tDCS over the left dorsolateral prefrontal cortex is able: 1) to reduce cortical hypersensitivity and habituation as assessed by VEPs and contact heat evoked nociceptive potentials (CHEPS), as well as to decrease pain perception assessed by quantitative sensory testing (QST) and the nociceptive blink reflex (nBR); 2) to decrease headache and migraine frequency.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cathodal Transcranial Direct Current Stimulation in Chronic Migraine: Neurophysiological Study and Pilot Therapeutic Trial
Study Start Date : September 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Experimental: Cathodal Cefaly tDCS
Cathodal Cefaly tDCS is delivered over the visual cortex at 2 mA of intensity, for 20 minutes, everyday for 2 months, in 14 patients. The anode is placed over the left DLPFC.
Device: Cefaly tDCS
Cefaly tDCS (transcranial direct current stimulation) is able to modify cortical excitability, in particular cathodal tDCS decreases 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 migraine frequency at baseline, 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. Scores at psychological scales [ Time Frame: 6 months ]
    The investigators evaluate scores at 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 chronic migraine (ICHD III beta 1.3) with or without medication overuse

Exclusion Criteria:

  • 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): NCT02122237


Locations
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Belgium
Roberta Baschi
Liège, Belgium, 4000
Sponsors and Collaborators
University of Liege
Investigators
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Principal Investigator: Delphine Magis, MD,PhD University of Liège
Study Director: Jean Schoenen, MD,PhD University of Liège

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Responsible Party: Jean Schoenen, Honorary Full Professor, University of Liege
ClinicalTrials.gov Identifier: NCT02122237     History of Changes
Other Study ID Numbers: CB-1289
First Posted: April 24, 2014    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases