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

Chronic Migraine Clinical Trial

Official title:

Randomized Double-Blind Sham-Controlled Study of the Effects of Transcranial Direct Current Stimulation in Refractory Chronic Migraine and Medication-overuse Headache Patients

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01752439
• Other study ID #: tDCSCMMOH1
• Status: Enrolling by invitation
• Phase: N/A
• First received: December 11, 2012
• Last updated: December 14, 2012
• Start date: February 2013
• Est. completion date: March 2014

Study information

• Verified date: December 2012
• Source: Mediterranean Neurological Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: March 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Device:
• Anodal transcranial direct current stimulation

• Sham transcranial direct current stimulation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dr Armando Perrotta, MD, PhD

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in headache days per months		at 30, 60 and 90 days after the treatment	No
Primary	Change in drugs intake per months		at 30, 60 and 90 days after treatment	No
Secondary	Change in mean pain intensity score per months		at 30, 60 and 90 days after treatment	No