tDCS in Chronic Migraine With Medication Overuse (Edisom)

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Migraine Disorders, Medication Overuse Headache

Intervention / Treatment
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* Device: tDCS


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: anodal tDCS<br>anodal tDCS stimulation | Device: tDCS<br>* transcranial direct current stimulation<br>|
| Active Comparator: cathodal tDCS<br>cathodal tDCS stimulation | Device: tDCS<br>* transcranial direct current stimulation<br>|
| Placebo Comparator: sham tDCS<br>sham tDCS stimulation (stopped after 30 seconds) | Device: tDCS<br>* transcranial direct current stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| days of headache per month (long-term) | no. patients with 50% reduction of days of headache per month | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| days of headache per month (mid-term) | no. patients with 50% reduction of days of headache per month | 6 months | 
| analgesic intake per month | percentage of reduction of analgesic intake per month compared to baseline | 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. | 6 and 12 months | 
| catastrophizing attitude | Pain Catastrophizing Scale (PCS) pathological more than 30 (total score) no cut off for the subscales | 6 and 12 months | 
| depression | Beck Depression Inventory (BDI) score more than 7 | 6 and 12 months | 
| state and trait anxiety | Spielberger questionnaires STAIY1-Y2 ; score between 20-80 | 6 and 12 months | 
| dependence attitude | Leed questionnaire score Under 10: low dependency 10-22: medium dependency more than 22: high dependency | 6 and 12 months | 
| allodynia intensity | Allodynia Symptoms Checklist | 6 and 12 months |