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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Dr Armando Perrotta, MD, PhD, Mediterranean Neurological Institute
ClinicalTrials.gov Identifier:
NCT01752439
First received: December 11, 2012
Last updated: December 14, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
Chronic Migraine
Medication Overuse Headache
 Device: Anodal transcranial direct current stimulation
Device: Sham transcranial direct current stimulation

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

Resource links provided by NLM:

MedlinePlus related topics: Headache Migraine
U.S. FDA Resources

Further study details as provided by Mediterranean Neurological Institute:

Primary Outcome Measures:
  • Change in headache days per months [ Time Frame: at 30, 60 and 90 days after the treatment ] [ Designated as safety issue: No ]
  • Change in drugs intake per months [ Time Frame: at 30, 60 and 90 days after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in mean pain intensity score per months [ Time Frame: at 30, 60 and 90 days after treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: February 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Anodal transcranial direct current stimulation
Anodal transcranial direct current stimulation
 Device: Anodal transcranial direct current stimulation
Other Name: Transcranial direct current stimulator HDCstim, Newronika s.r.l., Milan, Italy
Sham Comparator: Sham transcranial direct current stimulation
Sham transcranial direct current stimulation
 Device: Sham transcranial direct current stimulation
Other Name: Transcranial direct current stimulator HDCstim, Newronika s.r.l., Milan, Italy
No Intervention: Control group

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Dr Armando Perrotta, MD, PhD, MD, PhD, Mediterranean Neurological Institute
ClinicalTrials.gov Identifier: NCT01752439     History of Changes
Other Study ID Numbers: tDCSCMMOH1
Study First Received: December 11, 2012
Last Updated: December 14, 2012
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Mediterranean Neurological Institute:
Chronic Migraine
Medication Overuse Headache
Refractory
transcranial direct current stimulation

Additional relevant MeSH terms:
Headache
Migraine Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
 Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on May 22, 2013