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
|Condition or disease||Intervention/treatment||Phase|
|Chronic Migraine||Device: Cefaly tDCS||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- Migraine frequency [ Time Frame: 6 months ]The investigators evaluate migraine frequency at baseline, 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.
- 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.
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
|Liège, Belgium, 4000|
|Principal Investigator:||Delphine Magis, MD,PhD||University of Liège|
|Study Director:||Jean Schoenen, MD,PhD||University of Liège|