Migraine Disorders Clinical Trial
Official title:
Long-term Efficacy of Transcranial Direct Current Stimulation in Chronic Migraine With Medication Overuse: a Phase III, Placebo Controlled, Randomised Clinical Trial (Edisom)
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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