tDCS in Chronic Migraine With Medication Overuse (Edisom)

Not Applicable

Completed

• Conditions: Medication Overuse Headache; Migraine Disorders
• Interventions: Device: tDCS

• Registration Number: NCT04228809
• Lead Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

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.

Study Timeline

• Study Start: 2015-12-01
• Primary Completion: 2017-06-30
• Study Completion: 2018-05-30
• Study First Submitted: 2020-01-04
• Study First Submitted QC: 2020-01-10
• Study First Posted: 2020-01-14
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-12
• Last Update Posted: 2020-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
anodal tDCS	tDCS	anodal tDCS stimulation
cathodal tDCS	tDCS	cathodal tDCS stimulation
sham tDCS	tDCS	sham tDCS stimulation (stopped after 30 seconds)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
analgesic intake per month	6 and 12 months	percentage of reduction of analgesic intake per month compared to baseline
state and trait anxiety	6 and 12 months	Spielberger questionnaires STAIY1-Y2 ; score between 20-80
dependence attitude	6 and 12 months	Leed questionnaire score; Under 10: low dependency; 10-22: medium dependency; more than 22: high dependency
catastrophizing attitude	6 and 12 months	Pain Catastrophizing Scale (PCS) pathological more than 30 (total score) no cut off for the subscales
allodynia intensity	6 and 12 months	Allodynia Symptoms Checklist
days of headache per month (mid-term)	6 months	no. patients with 50% reduction of days of headache per month
disability	6 and 12 months	Migraine Disability Assessment (MIDAS). MIDAS-score; 0-:5 low disability; 6-10: MILD disability 11-20: Moderate disability more than 2:0 Severe disability.
depression	6 and 12 months	Beck Depression Inventory (BDI) score more than 7