- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02122237
Cathodal tDCS in Chronic Migraine: Neurophysiological Study and Pilot Therapeutic Trial (CATCHROMIG)
Cathodal Transcranial Direct Current Stimulation in Chronic Migraine: Neurophysiological Study and Pilot Therapeutic Trial
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Liège, Belgium, 4000
- Roberta Baschi
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Migraine frequency
Time Frame: 6 months
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The investigators evaluate migraine frequency at baseline, during the treatment and 2 months after its end.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Migraine intensity
Time Frame: 6 months
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The investigators evaluate migraine intensity at baseline, during the treatment and 2 months after its end.
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6 months
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Acute medication intake
Time Frame: 6 months
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The investigators evaluate acute medication intake at baseline, during the treatment and 2 months after its end.
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6 months
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Attack duration
Time Frame: 6 months
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The investigators evaluate attack duration at baseline, during the treatment and 2 months after its end.
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6 months
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Scores at psychological scales
Time Frame: 6 months
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The investigators evaluate scores at psychological scales at baseline, during the treatment and 2 months after its end.
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6 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CB-1289
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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University of FlorenceAzienda Ospedaliera Città della Salute e della Scienza di Torino; University... and other collaboratorsRecruitingMigraine | Chronic Migraine | Migraine Without Aura | Migraine With AuraItaly
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Glostrup University Hospital, CopenhagenUnknownChronic Migraine | Migraine Without Aura | Migraine With AuraDenmark
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Cefaly TechnologyCompleted
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Cefaly TechnologyCompleted
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Cefaly TechnologyCompleted
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Cefaly TechnologyCompleted