Effects of Transcranial Direct Current Stimulation in Refractory Chronic Migraine and Medication-overuse Headache

Not Applicable

• Conditions: Chronic Migraine; Medication Overuse Headache
• Interventions: Device: Anodal transcranial direct current stimulation; Device: Sham transcranial direct current stimulation

• Registration Number: NCT01752439
• Lead Sponsor: Dr Armando Perrotta, MD, PhD

Brief Summary

The purpose of the study is to evaluate the efficacy of the transcranial direct current stimulation of the primary motor cortex (M1) in patients affected by refractory chronic migraine (coded as 1.5.1 in the international headache classification 2nd edition, 2004) and medication-overuse headache (coded as 8.1) with migraine as primary headache.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-12
• Study First Submitted: 2012-12-11
• Study First Submitted QC: 2012-12-14
• Last Update Submitted: 2012-12-14
• Study First Posted: 2012-12-19
• Last Update Posted: 2012-12-19
• Study Start: 2013-02
• Primary Completion: 2013-12
• Study Completion: 2014-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Chronic MIgraine or Medication Overuse Headache according to the diagnostic criteria set out in the 2nd edition of the International Classification of Headache Disorders refractory to treatment according to the Refractory Headache Special Interest Section of the American Headache Society (Schulman et al., 2008)

Exclusion Criteria

• Other primary or secondary headaches.
• Any serious systemic or neurological disease or psychiatric disorder.
• Pregnancy or breastfeeding
• Previous or current use of other or similar devices for pain control
• Heart conduction and rhythm disorders
• Cranial surgery
• Other pain conditions, accordingly with current guidelines

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anodal transcranial direct current stimulation	Anodal transcranial direct current stimulation	Anodal transcranial direct current stimulation
Sham transcranial direct current stimulation	Sham transcranial direct current stimulation	Sham transcranial direct current stimulation

Primary Outcome Measures

Name	Time	Method
Change in headache days per months	at 30, 60 and 90 days after the treatment
Change in drugs intake per months	at 30, 60 and 90 days after treatment

Secondary Outcome Measures

Name	Time	Method
Change in mean pain intensity score per months	at 30, 60 and 90 days after treatment