Transcranial Direct Current Simulation in Chronic Migraine

NCT ID: NCT02817139

Last Updated: 2016-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2016-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Migraine Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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active tDCS over primary motor cortex

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

Group Type ACTIVE_COMPARATOR

TDCS

Intervention Type DEVICE

active tDCS over prefrontal cortex

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

Group Type EXPERIMENTAL

TDCS

Intervention Type DEVICE

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.

Group Type PLACEBO_COMPARATOR

TDCS

Intervention Type DEVICE

Interventions

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TDCS

Intervention Type DEVICE

Other Intervention Names

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Transcranial Direct Current Stimulation

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of Paraíba

OTHER

Sponsor Role lead

Responsible Party

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Suellen Marinho Andrade

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Suellen Andrade

João Pessoa, Paraíba, Brazil

Site Status RECRUITING

Countries

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Brazil

Facility Contacts

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Suellen Andrade

Role: primary

Role: backup

Other Identifiers

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migraine

Identifier Type: -

Identifier Source: org_study_id

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