NCT04228809

tDCS in Chronic Migraine With Medication Overuse (Edisom)

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Migraine Disorders
• Medication Overuse Headache

Interventions

Type	Name	Description
DEVICE	tDCS	transcranial direct current stimulation

Timeline

• Start date: 2015-12-01
• Primary completion: 2017-06-30
• Completion: 2018-05-30
• First posted: 2020-01-14
• Last updated: 2020-02-17