Clincosm LogoSign in Get a demo

Transcranial Direct Current Simulation in Chronic Migraine

Sponsor
Federal University of Paraíba (Other)
Overall Status
Unknown status
CT.gov ID
NCT02817139
Collaborator
(none)
15
Enrollment
1
Location
3
Arms
3
Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is a pilot, double-blind, placebo-controlled, randomized trial aiming to compare the effects of transcranial direct current stimulation in Chronic Migraine.

Condition or Disease Intervention/Treatment Phase
  • Device: TDCS
 Phase 1/Phase 2

Detailed Description

The patients will be randomized into 1 of 3 groups: active tDCS over primary motor cortex, active tDCS over prefrontal cortex, sham tDCS. Each group will receive treatment for 20 minutes a day, 3 days a week for 4 weeks.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Transcranial Direct Current Simulation Over Primary Motor vs Prefrontal Cortex in Chronic Migraine: a Pilot Randomized Controlled Trial
Study Start Date :
Jun 1, 2016
Actual Primary Completion Date :
Jun 1, 2016
Anticipated Study Completion Date :
Sep 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: active tDCS over primary motor cortex

Duration: 20 minutes; Intensity: 2 mA; Placement: left primary motor cortex.

Device: TDCS
Other Names:
  • Transcranial Direct Current Stimulation

    		•
    Experimental: active tDCS over prefrontal cortex

    Duration: 20 minutes; Intensity: 2 mA; Placement: left prefrontal cortex.

    Device: TDCS
    Other Names:
  • Transcranial Direct Current Stimulation

    		•
    Placebo Comparator: sham tDCS over primary motor cortex

    Duration: 20 minutes; The procedure is the same as for active tDCS, but the in the placebo tDCS the stimulation is non-active / sham; Placement: left primary motor cortex.

    Device: TDCS
    Other Names:
  • Transcranial Direct Current Stimulation

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in quality of life associate to migraine assessed on the Headache Impact Test-6 (HIT-6) [Baseline (week 1) and Endpoint (week 4)]

    Secondary Outcome Measures

    1. Change in pain assessed on the Visual Analogue Scale (VAS) [Baseline (week 1) and Endpoint (week 4)]

    2. Change in quality of life assessed on the Medical Outcomes Study 36 - Item Short - Form Health Survey(SF-36) [Baseline (week 1) and and Endpoint (week 4)]

    3. Side Effects Questionnaire [From date of first neurostimulation until the date of last neurostimulation, , assessed up to 1 month]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • patients with a clinical diagnosis of chronic migraine according to the International Classification of Headaches Disorders (ICHD-3 beta) of the International Headache Society, with an established headache history occurring on 15 or more days per month-however, for at least 1 year, instead of only 3 months, as defined in the International Headache Society (IHS) guidelines.
    Exclusion Criteria:
    • headache attributable to some pathological condition, associated neurologic or neuropsychiatric disease, use of central nervous system modulating drugs, pregnancy, metallic head implants, and use of a cardiac pacemaker.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Suellen Andrade João Pessoa PB Brazil

    Sponsors and Collaborators

    • Federal University of Paraíba

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Suellen Marinho Andrade, Professor, Federal University of Paraíba
    ClinicalTrials.gov Identifier:
    NCT02817139
    Other Study ID Numbers:
    • migraine
    First Posted:
    Jun 29, 2016
    Last Update Posted:
    Jun 29, 2016
    Last Verified:
    Jun 1, 2016
    Additional relevant MeSH terms:
    Migraine Disorders

    Study Results

    No Results Posted as of Jun 29, 2016