search
Back to results

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

Primary Purpose

Chronic Migraine, Medication Overuse Headache

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Anodal transcranial direct current stimulation
Sham transcranial direct current stimulation
Sponsored by
Dr Armando Perrotta, MD, PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Migraine focused on measuring Chronic Migraine, Medication Overuse Headache, Refractory, transcranial direct current stimulation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Sham Comparator

    No Intervention

    Arm Label

    Anodal transcranial direct current stimulation

    Sham transcranial direct current stimulation

    Control group

    Arm Description

    Anodal transcranial direct current stimulation

    Sham transcranial direct current stimulation

    Outcomes

    Primary Outcome Measures

    Change in headache days per months
    Change in drugs intake per months

    Secondary Outcome Measures

    Change in mean pain intensity score per months

    Full Information

    First Posted
    December 11, 2012
    Last Updated
    December 14, 2012
    Sponsor
    Dr Armando Perrotta, MD, PhD
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01752439
    Brief Title
    Effects of Transcranial Direct Current Stimulation in Refractory Chronic Migraine and Medication-overuse Headache
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2012
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2013 (undefined)
    Primary Completion Date
    December 2013 (Anticipated)
    Study Completion Date
    March 2014 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Dr Armando Perrotta, MD, PhD

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Migraine, Medication Overuse Headache
    Keywords
    Chronic Migraine, Medication Overuse Headache, Refractory, transcranial direct current stimulation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Anodal transcranial direct current stimulation
    Arm Type
    Experimental
    Arm Description
    Anodal transcranial direct current stimulation
    Arm Title
    Sham transcranial direct current stimulation
    Arm Type
    Sham Comparator
    Arm Description
    Sham transcranial direct current stimulation
    Arm Title
    Control group
    Arm Type
    No Intervention
    Intervention Type
    Device
    Intervention Name(s)
    Anodal transcranial direct current stimulation
    Other Intervention Name(s)
    Transcranial direct current stimulator HDCstim, Newronika s.r.l., Milan, Italy
    Intervention Type
    Device
    Intervention Name(s)
    Sham transcranial direct current stimulation
    Other Intervention Name(s)
    Transcranial direct current stimulator HDCstim, Newronika s.r.l., Milan, Italy
    Primary Outcome Measure Information:
    Title
    Change in headache days per months
    Time Frame
    at 30, 60 and 90 days after the treatment
    Title
    Change in drugs intake per months
    Time Frame
    at 30, 60 and 90 days after treatment
    Secondary Outcome Measure Information:
    Title
    Change in mean pain intensity score per months
    Time Frame
    at 30, 60 and 90 days after treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs