tDCS in Chronic Migraine With Medication Overuse (Edisom)

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: June 30, 2017

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.

Interventions

  • Device: tDCS
    • transcranial direct current stimulation

Arms, Groups and Cohorts

  • Experimental: anodal tDCS
    • anodal tDCS stimulation
  • Active Comparator: cathodal tDCS
    • cathodal tDCS stimulation
  • Placebo Comparator: sham tDCS
    • sham tDCS stimulation (stopped after 30 seconds)

Clinical Trial Outcome Measures

Primary Measures

  • days of headache per month (long-term)
    • Time Frame: 12 months
    • no. patients with 50% reduction of days of headache per month

Secondary Measures

  • days of headache per month (mid-term)
    • Time Frame: 6 months
    • no. patients with 50% reduction of days of headache per month
  • analgesic intake per month
    • Time Frame: 6 and 12 months
    • percentage of reduction of analgesic intake per month compared to baseline
  • disability
    • Time Frame: 6 and 12 months
    • Migraine Disability Assessment (MIDAS)
  • catastrophizing attitude
    • Time Frame: 6 and 12 months
    • Pain Catastrophizing Scale
  • depression
    • Time Frame: 6 and 12 months
    • Beck Depression Inventory
  • state and trait anxiety
    • Time Frame: 6 and 12 months
    • Spielberger questionnaires
  • dependence attitude
    • Time Frame: 6 and 12 months
    • Leed questionnaire
  • allodynia intensity
    • Time Frame: 6 and 12 months
    • Allodynia Symptoms Checklist

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
  • Collaborator
    • University of Milano Bicocca
  • Provider of Information About this Clinical Study
    • Sponsor

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