Evaluation of the Prophylactic Efficacy of tDCS in Chronic Migraine

N/ACompletedNCT02120326

University Hospital, Grenoble36 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

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

Interventions

Transcranial direct current stimulation of the motor cortexDEVICE

The area of stimulation is determined by by EEG system 10/20. The two electrodes are soaked in saline and then placed on the scalp. Stimulation parameters: * 2 mA intensity * Continuous stimulation for 20 min with rise times and fall times of 10 seconds each

simulation of Transcranial direct current stimulation of the motor cortexDEVICE

The area of stimulation is determined by by EEG system 10/20. The two electrodes are soaked in saline and then placed on the scalp. Stimulation parameters: * The intensity of the stimulation current is 2 mA * The current is applied during the first 30 seconds with rise times and fall times of 10 seconds each. Then the session will be continued without actual stimulation.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (2)

Grenoble University Hospital

Grenoble, Isere, France

Hospital of Voiron

Voiron, Isere, France

Outcomes

Primary Outcomes

Comparison of the evolution of seizure frequency between the two groups

Time frame: Evolution of seizure frequency since base line to 3 months after the end of tDCS

Secondary Outcomes

Comparison of the evolution of seizure severity between the two groups

Headache Impact Test 6 (HIT-6) questionnaire

Time frame: Evolution of seizure severity since base line to 3 months after the end of tDCS

Comparison of the evolution of crisis treatment use between the two groups

Frequency of taking crisis treatment. After each crisis, taking crisis treatment will be noted by the patient on his migraine record book.

Time frame: Evolution of crisis treatment use since base line until 3 months after the end of tDCS

Comparison of the evolution of the disease impact between the two groups

Migraine Disability Assessment Scale (MIDAS) scale

Time frame: Evolution of the disease impact since base line to 3 months after the end of tDCS

Comparison of the evolution of the patient satisfaction between the two groups

Clinical Global Impression (CGI) scale

Time frame: Evolution of the patient satisfaction since base line to 3 months after the end of tDCS

Comparison of the evolution of the quality of life between the two groups

Short Form 12 (SF-12) quality of life questionnaire

Time frame: Evolution of the quality of life since base line until 3 months after the end of tDCS

Comparison of the evolution of anxiety and depression levels between the two groups

Data from ClinicalTrials.gov

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