tDCS
Devicetranscranial direct current stimulation
NCT Number: NCT04228809
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
transcranial direct current stimulation
Time frame: 12 months
no. patients with 50% reduction of days of headache per month
Time frame: 6 months
no. patients with 50% reduction of days of headache per month
Time frame: 6 and 12 months
percentage of reduction of analgesic intake per month compared to baseline
Time frame: 6 and 12 months
Migraine Disability Assessment (MIDAS). MIDAS-score
0-:5 low disability
6-10: MILD disability 11-20: Moderate disability more than 2:0 Severe disability.
Time frame: 6 and 12 months
Pain Catastrophizing Scale (PCS) pathological more than 30 (total score) no cut off for the subscales
Time frame: 6 and 12 months
Beck Depression Inventory (BDI) score more than 7
Time frame: 6 and 12 months
Spielberger questionnaires STAIY1-Y2 ; score between 20-80
Time frame: 6 and 12 months
Leed questionnaire score
Under 10: low dependency
10-22: medium dependency
more than 22: high dependency
Time frame: 6 and 12 months
Allodynia Symptoms Checklist
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Other
Long-term Efficacy of Transcranial Direct Current Stimulation in Chronic Migraine With Medication Overuse: a Phase III, Placebo Controlled, Randomised Clinical Trial (Edisom)
Acronym: Edisom
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