tDCS in Chronic Migraine With Medication Overuse (Edisom)

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta135 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

135

Conditions

Migraine Disorders Medication Overuse Headache

Interventions

tDCSDEVICE

transcranial direct current stimulation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

no. patients with 50% reduction of days of headache per month

Time frame: 12 months

Secondary Outcomes

days of headache per month (mid-term)

no. patients with 50% reduction of days of headache per month

Time frame: 6 months

analgesic intake per month

percentage of reduction of analgesic intake per month compared to baseline

Time frame: 6 and 12 months

disability

Migraine Disability Assessment (MIDAS). MIDAS-score 0-:5 low disability 6-10: MILD disability 11-20: Moderate disability more than 2:0 Severe disability.

Time frame: 6 and 12 months

catastrophizing attitude

Pain Catastrophizing Scale (PCS) pathological more than 30 (total score) no cut off for the subscales

Time frame: 6 and 12 months

depression

Beck Depression Inventory (BDI) score more than 7

Time frame: 6 and 12 months

state and trait anxiety

Spielberger questionnaires STAIY1-Y2 ; score between 20-80

Time frame: 6 and 12 months

dependence attitude

Leed questionnaire score Under 10: low dependency 10-22: medium dependency more than 22: high dependency

Time frame: 6 and 12 months

Data from ClinicalTrials.gov

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