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| Name | Class |
|---|---|
| University of Milano Bicocca | OTHER |
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Transcranial direct current stimulation (tDCS) was suggested to provide beneficial effects in chronic migraine (CM), a condition often associated with medication overuse (MO) for which no long-term therapy is available.
We conducted a randomized controlled trial to assess long-term efficacy of tDCS. Adults diagnosed with CM and MO were assigned to receive in a 1:1:1 ratio anodal, cathodal, or sham tDCS daily for five consecutive days, along with standardized drug withdrawal protocol with intravenous administration of dexamethasone 4 mg and ademetionine 200 mg in saline solution, and oral bromazepam 1.5 mg three times daily.
Primary outcome was 50% reduction of days of headache per month at 12 months. Co-secondary outcomes were 50% reduction of days of headache per month at 6 months, reduction of analgesic intake per month, and change in disability and quality of life, catastrophizing, depression, state and trait anxiety, dependence attitude and allodynia intensity. Patients were not allowed to take any migraine prophylaxis drug for the entire study period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| anodal tDCS | Experimental | anodal tDCS stimulation |
|
| cathodal tDCS | Active Comparator | cathodal tDCS stimulation |
|
| sham tDCS | Placebo Comparator | sham tDCS stimulation (stopped after 30 seconds) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tDCS | Device | transcranial direct current stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| days of headache per month (long-term) | no. patients with 50% reduction of days of headache per month | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| days of headache per month (mid-term) | no. patients with 50% reduction of days of headache per month | 6 months |
| analgesic intake per month | percentage of reduction of analgesic intake per month compared to baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32536270 | Derived | Grazzi L, Usai S, Bolognini N, Grignani E, Sansone E, Tramacere I, Maravita A, Lauria G. No efficacy of transcranial direct current stimulation on chronic migraine with medication overuse: A double blind, randomised clinical trial. Cephalalgia. 2020 Oct;40(11):1202-1211. doi: 10.1177/0333102420931050. Epub 2020 Jun 14. |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D051271 | Headache Disorders, Secondary |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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sham
| 6 and 12 months |
| disability | Migraine Disability Assessment (MIDAS). MIDAS-score 0-:5 low disability 6-10: MILD disability 11-20: Moderate disability more than 2:0 Severe disability. | 6 and 12 months |
| catastrophizing attitude | Pain Catastrophizing Scale (PCS) pathological more than 30 (total score) no cut off for the subscales | 6 and 12 months |
| depression | Beck Depression Inventory (BDI) score more than 7 | 6 and 12 months |
| state and trait anxiety | Spielberger questionnaires STAIY1-Y2 ; score between 20-80 | 6 and 12 months |
| dependence attitude | Leed questionnaire score Under 10: low dependency 10-22: medium dependency more than 22: high dependency | 6 and 12 months |
| allodynia intensity | Allodynia Symptoms Checklist | 6 and 12 months |
| D009422 | Nervous System Diseases |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |