Evaluation of the Prophylactic Efficacy of tDCS in Chronic Migraine (Medis)

Grenoble Alpes University Hospital Center (CHU)

Status

Completed

Conditions

Chronic Migraine as Defined by Criteria of International Headache Society (IHS)

Treatments

Device: simulation of Transcranial direct current stimulation of the motor cortex

Device: Transcranial direct current stimulation of the motor cortex

Study type

Interventional

Funder types

Other

Identifiers

NCT02120326

DCIC13/48

Details and patient eligibility

About

The purpose of this study is to determine whether TDCS is an effective prophylactic therapy of chronic migraine.

Full 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 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.

Enrollment

36 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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