Evaluation of the Prophylactic Efficacy of tDCS in Chronic Migraine

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

Detailed Description
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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.

Official Title
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Randomised Double-blind Evaluation of the Prophylactic Efficacy of Transcranial Direct Current Stimulation (tDCS) in Chronic Migraine

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

Intervention / Treatment
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* Device: Transcranial direct current stimulation of the motor cortex
* Device: simulation of Transcranial direct current stimulation of the motor cortex


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: active tDCS<br> | Device: Transcranial direct current stimulation of the motor cortex<br>* 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<br>|
| Placebo Comparator: simulated tDCS<br> | Device: simulation of Transcranial direct current stimulation of the motor cortex<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the evolution of seizure frequency between the two groups |  | Evolution of seizure frequency since base line to 3 months after the end of tDCS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the evolution of seizure severity between the two groups | Headache Impact Test 6 (HIT-6) questionnaire | 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. | 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 | 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 | 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 | 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 | Hospital Anxiety and Depression scale (HAD) questionnaire | Evolution of anxiety and depression levels since base line until 3 months after the end of tDCS | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic migraine, tDCS, Transcranial direct current stimulation