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Completed

NCT Number: NCT02122237

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

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

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Roberta Baschi

Liège, Belgium, 4000

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cefaly tDCS

Device

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 outcomes

  1. Migraine frequency

    Time frame: 6 months

    The investigators evaluate migraine frequency at baseline, during the treatment and 2 months after its end.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Registry information

Official study title

Cathodal Transcranial Direct Current Stimulation in Chronic Migraine: Neurophysiological Study and Pilot Therapeutic Trial

Acronym: CATCHROMIG

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 24, 2014
Registry last updated
May 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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