tDCS in Chronic Migraine With Medication Overuse (Edisom) (Edisom)

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

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.

Study Overview

• Status: Completed
• Conditions: Migraine Disorders; Medication Overuse Headache
• Intervention / Treatment: Device: tDCS

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 Type: Interventional
• Enrollment (Actual): 135
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: anodal tDCS; anodal tDCS stimulation	Device: tDCS; transcranial direct current stimulation
Active Comparator: cathodal tDCS; cathodal tDCS stimulation	Device: tDCS; transcranial direct current stimulation
Placebo Comparator: sham tDCS; sham tDCS stimulation (stopped after 30 seconds)	Device: tDCS; transcranial direct current stimulation

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
• Collaborators: University of Milano Bicocca

Publications and helpful links

General Publications

• Grazzi L, Usai S, Bolognini N, Grignani E, Sansone E, Tramacere I, Maravita A, Lauria G. No efficacy of transcranial direct current stimulation on chronic migraine with medication overuse: A double blind, randomised clinical trial. Cephalalgia. 2020 Oct;40(11):1202-1211. doi: 10.1177/0333102420931050. Epub 2020 Jun 14.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Actual): June 30, 2017
• Study Completion (Actual): May 30, 2018

Study Registration Dates

• First Submitted: January 4, 2020
• First Submitted That Met QC Criteria: January 10, 2020
• First Posted (Actual): January 14, 2020

Study Record Updates

• Last Update Posted (Actual): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 12, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Headache; Headache Disorders, Secondary
• Other Study ID Numbers: Edisom

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No