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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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Start Date
December 1, 2015
Primary Completion Date
June 30, 2017
Completion Date
May 30, 2018
Last Updated
February 17, 2020
135
ACTUAL participants
tDCS
DEVICE
Lead Sponsor
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05570149