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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active tDCS | Experimental |
| |
| simulated tDCS | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial direct current stimulation of the motor cortex | Device | 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:
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| HODAJ Hasan, MD | University Hospital, Grenoble | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grenoble University Hospital | Grenoble | Isere | 38043 | France | ||
| Hospital of Voiron |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35219923 | Result | Hodaj H, Payen JF, Mick G, Vercueil L, Hodaj E, Dumolard A, Noelle B, Delon-Martin C, Lefaucheur JP. Long-term prophylactic efficacy of transcranial direct current stimulation in chronic migraine. A randomised, patient-assessor blinded, sham-controlled trial. Brain Stimul. 2022 Mar-Apr;15(2):441-453. doi: 10.1016/j.brs.2022.02.012. Epub 2022 Feb 25. |
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|
| simulation of Transcranial direct current stimulation of the motor cortex | Device | 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:
|
|
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 |
| Voiron |
| Isere |
| 38500 |
| France |