Chronic Migraine as Defined by Criteria of International Headache Society (IHS)
Conditions
Keywords
Chronic migraine, tDCS, Transcranial direct current stimulation
Brief summary
The purpose of this study is to determine whether TDCS is an effective prophylactic therapy of chronic migraine.
Detailed 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.
Interventions
DEVICETranscranial direct current stimulation of the motor cortex
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
DEVICEsimulation of Transcranial direct current stimulation of the motor cortex
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.
Sponsors
University Hospital, Grenoble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the evolution of crisis treatment use between the two groups | Evolution of crisis treatment use since base line until 3 months after the end of tDCS | Frequency of taking crisis treatment. After each crisis, taking crisis treatment will be noted by the patient on his migraine record book. |
| Comparison of the evolution of the disease impact between the two groups | Evolution of the disease impact since base line to 3 months after the end of tDCS | Migraine Disability Assessment Scale (MIDAS) scale |
| Comparison of the evolution of seizure severity between the two groups | Evolution of seizure severity since base line to 3 months after the end of tDCS | Headache Impact Test 6 (HIT-6) questionnaire |
| Comparison of the evolution of the quality of life between the two groups | Evolution of the quality of life since base line until 3 months after the end of tDCS | Short Form 12 (SF-12) quality of life questionnaire |
| Comparison of the evolution of anxiety and depression levels between the two groups | Evolution of anxiety and depression levels since base line until 3 months after the end of tDCS | Hospital Anxiety and Depression scale (HAD) questionnaire |
| Comparison of the evolution of the patient satisfaction between the two groups | Evolution of the patient satisfaction since base line to 3 months after the end of tDCS | Clinical Global Impression (CGI) scale |
Countries
France
Outcome results
None listed