Cathodal tDCS in Chronic Migraine: Neurophysiological Study and Pilot Therapeutic Trial (CATCHROMIG)
Primary Purpose
Chronic Migraine
Status
Completed
Phase
Phase 3
Locations
Belgium
Study Type
Interventional
Intervention
Cefaly tDCS
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Migraine
Eligibility 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)
Sites / Locations
- Roberta Baschi
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cathodal Cefaly tDCS
Arm Description
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.
Outcomes
Primary Outcome Measures
Migraine frequency
The investigators evaluate migraine frequency at baseline, during the treatment and 2 months after its end.
Secondary Outcome Measures
Migraine intensity
The investigators evaluate migraine intensity at baseline, during the treatment and 2 months after its end.
Acute medication intake
The investigators evaluate acute medication intake at baseline, during the treatment and 2 months after its end.
Attack duration
The investigators evaluate attack duration at baseline, during the treatment and 2 months after its end.
Scores at psychological scales
The investigators evaluate scores at psychological scales at baseline, during the treatment and 2 months after its end.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02122237
Brief Title
Cathodal tDCS in Chronic Migraine: Neurophysiological Study and Pilot Therapeutic Trial
Acronym
CATCHROMIG
Official Title
Cathodal Transcranial Direct Current Stimulation in Chronic Migraine: Neurophysiological Study and Pilot Therapeutic Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Liege
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Migraine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cathodal Cefaly tDCS
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Cefaly tDCS
Intervention Description
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 Measure Information:
Title
Migraine frequency
Description
The investigators evaluate migraine frequency at baseline, during the treatment and 2 months after its end.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Migraine intensity
Description
The investigators evaluate migraine intensity at baseline, during the treatment and 2 months after its end.
Time Frame
6 months
Title
Acute medication intake
Description
The investigators evaluate acute medication intake at baseline, during the treatment and 2 months after its end.
Time Frame
6 months
Title
Attack duration
Description
The investigators evaluate attack duration at baseline, during the treatment and 2 months after its end.
Time Frame
6 months
Title
Scores at psychological scales
Description
The investigators evaluate scores at psychological scales at baseline, during the treatment and 2 months after its end.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Delphine Magis, MD,PhD
Organizational Affiliation
University of Liege
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean Schoenen, MD,PhD
Organizational Affiliation
University of Liege
Official's Role
Study Director
Facility Information:
Facility Name
Roberta Baschi
City
Liège
ZIP/Postal Code
4000
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Cathodal tDCS in Chronic Migraine: Neurophysiological Study and Pilot Therapeutic Trial
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