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

December 14, 2012 updated by: Dr Armando Perrotta, MD, PhD

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Experimental: Anodal transcranial direct current stimulation
Device: Anodal transcranial direct current stimulation
Other Names:
  • Transcranial direct current stimulator HDCstim, Newronika s.r.l., Milan, Italy
Sham Comparator: Sham transcranial direct current stimulation
Device: Sham transcranial direct current stimulation
Other Names:
  • Transcranial direct current stimulator HDCstim, Newronika s.r.l., Milan, Italy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in headache days per months
Time Frame: at 30, 60 and 90 days after the treatment
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
at 30, 60 and 90 days after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in mean pain intensity score per months
Time Frame: at 30, 60 and 90 days after treatment
at 30, 60 and 90 days after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr Armando Perrotta, MD, PhD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Anticipated)

December 1, 2013

Study Completion (Anticipated)

March 1, 2014

Study Registration Dates

First Submitted

December 11, 2012

First Submitted That Met QC Criteria

December 14, 2012

First Posted (Estimate)

December 19, 2012

Study Record Updates

Last Update Posted (Estimate)

December 19, 2012

Last Update Submitted That Met QC Criteria

December 14, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • tDCSCMMOH1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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