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

Chronic Migraine Clinical Trial

— CATCHROMIG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02122237
• Other study ID #: CB-1289
• Status: Completed
• Phase: Phase 3
• First received: November 4, 2013
• Last updated: May 27, 2015
• Start date: September 2013
• Est. completion date: September 2014

Study information

• Verified date: May 2015
• Source: University Hospital of Liege
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: September 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Migraine
• Migraine Disorders

Intervention

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.

Locations

Country	Name	City	State
Belgium	Roberta Baschi	Liège

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Migraine frequency	The investigators evaluate migraine frequency at baseline, during the treatment and 2 months after its end.	6 months
Secondary	Migraine intensity	The investigators evaluate migraine intensity at baseline, during the treatment and 2 months after its end.	6 months
Secondary	Acute medication intake	The investigators evaluate acute medication intake at baseline, during the treatment and 2 months after its end.	6 months
Secondary	Attack duration	The investigators evaluate attack duration at baseline, during the treatment and 2 months after its end.	6 months
Secondary	Scores at psychological scales	The investigators evaluate scores at psychological scales at baseline, during the treatment and 2 months after its end.	6 months