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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2012 by Dr Armando Perrotta, MD, PhD, Mediterranean Neurological Institute.
Recruitment status was:  Enrolling by invitation
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
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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:


Further study details as provided by Dr Armando Perrotta, MD, PhD, Mediterranean Neurological Institute:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Change in mean pain intensity score per months [ Time Frame: at 30, 60 and 90 days after treatment ]

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   (Adult)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

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

Keywords provided by Dr Armando Perrotta, MD, PhD, Mediterranean Neurological Institute:
Chronic Migraine
Medication Overuse Headache
Refractory
transcranial direct current stimulation

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

ClinicalTrials.gov processed this record on September 21, 2017