Long-term Efficacy of Transcranial Direct Current Stimulation in Chronic Migraine With Medication Overuse: a Phase III, Placebo Controlled, Randomised Clinical Trial (Edisom)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Migraine Disorders
- Sponsor
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
- Enrollment
- 135
- Primary Endpoint
- days of headache per month (long-term)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •chronic migraine with medication overuse according to the International Headache Society criteria. Diagnosis was confirmed on the basis of a daily headache diary that all eligible patients filled out in the last month prior to the enrollment. Patients should have failed at least two prophylaxis therapies. Written informed consent.
Exclusion Criteria
- •known diagnosis of major depression or other major psychiatric disorders identified after psychiatric consultation, cardiac pace maker, clips for previous head surgery, cochlear implant, history of epilepsy, known idiopathic intracranial hypertension, harmful alcohol consumption, pregnancy.
Outcomes
Primary Outcomes
days of headache per month (long-term)
Time Frame: 12 months
no. patients with 50% reduction of days of headache per month
Secondary Outcomes
- analgesic intake per month(6 and 12 months)
- state and trait anxiety(6 and 12 months)
- dependence attitude(6 and 12 months)
- catastrophizing attitude(6 and 12 months)
- allodynia intensity(6 and 12 months)
- days of headache per month (mid-term)(6 months)
- disability(6 and 12 months)
- depression(6 and 12 months)