tDCS in Chronic Migraine With Medication Overuse (Edisom)

Migraine Disorders Clinical Trial

— Edisom  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04228809
• Other study ID #: Edisom
• Status: Completed
• Phase: N/A
• Start date: December 1, 2015
• Est. completion date: May 30, 2018

Study information

• Verified date: February 2020
• Source: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: May 30, 2018
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Headache
• Headache Disorders, Secondary
• Medication Overuse Headache
• Migraine Disorders

Intervention

Device:
• tDCS
transcranial direct current stimulation

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta	University of Milano Bicocca

Outcome

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