Recruitment

Recruitment Status
Completed
Estimated Enrollment
60

Inclusion Criterias

Frequency of migraine crisis is above 8 per month during last month
Diagnosis of chronic migraine for more than 1 year
chronic migraine that has not been improved over the previous year by at least 3 different prophylactic treatments recommended and well conducted
...
Frequency of migraine crisis is above 8 per month during last month
Diagnosis of chronic migraine for more than 1 year
chronic migraine that has not been improved over the previous year by at least 3 different prophylactic treatments recommended and well conducted
Stable treatment since 1 month
Patient's written consent
Patient agreeing not to try other migraine prophylactic treatment, throughout the study

Exclusion Criterias

Presence of intracranial ferromagnetic material or an implanted stimulator
History of drug addiction, epilepsy, or severe head trauma with bone break
Person not understanding the study protocol
...
Presence of intracranial ferromagnetic material or an implanted stimulator
History of drug addiction, epilepsy, or severe head trauma with bone break
Person not understanding the study protocol
Pregnant women, parturient women, breast-feeding mother. Lack of effective contraception
Introduction of a new treatment for less than a month
History of psychiatric illness (psychosis and severe cognitive disorders) may interfere with the proper conduct of the study

Summary

Conditions
Chronic Migraine as Defined by Criteria of International Headache Society (IHS)
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Outcomes Assessor)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

Description

Consenting patients will report on a book, all of their migraine attack for 1 month. Then they will be randomized to the active tDCS group or sham tDCS group. Patients will have one session of tDCS per day during the first week, then one session per week for a month and finally a session every 15 da...

Consenting patients will report on a book, all of their migraine attack for 1 month. Then they will be randomized to the active tDCS group or sham tDCS group. Patients will have one session of tDCS per day during the first week, then one session per week for a month and finally a session every 15 days for 1 month. After tDCS sessions, patients will be followed for 3 months. Throughout their participation in the study, patients will complete their migraine record (1month of base line before tDCS, 2 months during tDCS, 3 months after tDCS). Patients will have 5 evaluation examinations: The first, one before tDCS, The second, 1 month after the beginning of tDCS The third, immediately after the end of tDCS The fourth, 1 month after the end of tDCS And the last one, 3 months after the end of tDCS. The physician responsible for conducting tDCS sessions will make the randomization via a website. The physician in charge of the evaluation examinations will don't know the allocated treatment.

Inclusion Criterias

Frequency of migraine crisis is above 8 per month during last month
Diagnosis of chronic migraine for more than 1 year
chronic migraine that has not been improved over the previous year by at least 3 different prophylactic treatments recommended and well conducted
...
Frequency of migraine crisis is above 8 per month during last month
Diagnosis of chronic migraine for more than 1 year
chronic migraine that has not been improved over the previous year by at least 3 different prophylactic treatments recommended and well conducted
Stable treatment since 1 month
Patient's written consent
Patient agreeing not to try other migraine prophylactic treatment, throughout the study

Exclusion Criterias

Presence of intracranial ferromagnetic material or an implanted stimulator
History of drug addiction, epilepsy, or severe head trauma with bone break
Person not understanding the study protocol
...
Presence of intracranial ferromagnetic material or an implanted stimulator
History of drug addiction, epilepsy, or severe head trauma with bone break
Person not understanding the study protocol
Pregnant women, parturient women, breast-feeding mother. Lack of effective contraception
Introduction of a new treatment for less than a month
History of psychiatric illness (psychosis and severe cognitive disorders) may interfere with the proper conduct of the study

Locations

Grenoble, Isere, 38043
Voiron, Isere, 38500
Grenoble, Isere, 38043
Voiron, Isere, 38500

Tracking Information

NCT #
NCT02120326
Collaborators
Not Provided
Investigators
  • Principal Investigator: HODAJ Hasan, MD University Hospital, Grenoble
  • HODAJ Hasan, MD University Hospital, Grenoble