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Clinical Trials/NCT01752439
NCT01752439
Unknown
Not Applicable

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

Dr Armando Perrotta, MD, PhD0 sites30 target enrollmentFebruary 2013
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ConditionsChronic MigraineMedication Overuse Headache

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Migraine
Sponsor
Dr Armando Perrotta, MD, PhD
Enrollment
30
Primary Endpoint
Change in headache days per months
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2013
End Date
March 2014
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Dr Armando Perrotta, MD, PhD
Responsible Party
Sponsor Investigator
Principal Investigator

Dr Armando Perrotta, MD, PhD

MD, PhD

Mediterranean Neurological Institute

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in headache days per months

Time Frame: at 30, 60 and 90 days after the treatment

Change in drugs intake per months

Time Frame: at 30, 60 and 90 days after treatment

Secondary Outcomes

  • Change in mean pain intensity score per months(at 30, 60 and 90 days after treatment)

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