Double-blind Randomized Clinical Trial of Transcranial Magnetic Stimulation in Chronic Migraine

NCT ID: NCT01496950

Last Updated: 2018-04-05

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2012-02-29

Brief Summary

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The purpose of this study is to determine whether active repetitive transcranial magnetic stimulation of the left dorsolateral prefrontal cortex is safe and effective for preventive treatment of chronic migraine, compared to placebo repetitive transcranial magnetic stimulation.

Detailed Description

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Patients with chronic migraine according to the criteria of the International Headache Society will be randomized to either active repetitive transcranial magnetic stimulation of the left dorsolateral prefrontal cortex or placebo repetitive transcranial magnetic stimulation, in a total of 23 sessions of treatment (15 sessions in the first month and 8 sessions in the second month of treatment). Outcomes will be evaluated at baseline, after one, two months after treatment, and one month after end of treatment

Conditions

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Chronic Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Active Comparator: Active rTMS

10Hz active rTMS delivered to the left dorsolateral prefrontal cortex

Group Type ACTIVE_COMPARATOR

10Hz active rTMS

Intervention Type DEVICE

10Hz active rTMS delivered to the left dorsolateral prefrontal cortex

Placebo

10Hz placebo rTMS delivered to the vertex

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DEVICE

10Hz placebo rTMS delivered to the vertex

Interventions

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10Hz active rTMS

10Hz active rTMS delivered to the left dorsolateral prefrontal cortex

Intervention Type DEVICE

Placebo

10Hz placebo rTMS delivered to the vertex

Intervention Type DEVICE

Other Intervention Names

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Repetitive transcranial magnetic stimulation Repetitive transcranial magnetic stimulation

Eligibility Criteria

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Inclusion Criteria

* chronic migraine according to the criteria of the International Headache Society
* no change in prophylactic medication in the past 3 months

Exclusion Criteria

* other neurological disorders
* bipolar disorder
* alcohol or drug dependence in the past 2 months
* suicidal ideation, psychotic symptoms
* contraindications to transcranial magnetic stimulation (cardiac pacemaker, implanted electronic devices, metal in the skull, skull fractures, history of seizures)
* use of antidepressants in the past 4 weeks
* pregnancy or lack of birth-control method in women of childbearing age
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

Hospital Israelita Albert Einstein

OTHER

Sponsor Role lead

Responsible Party

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Adriana Conforto

Professor of Neurology, MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adriana Conforto, MD,PHD

Role: PRINCIPAL_INVESTIGATOR

Instituto Israelita de Ensino e Pesquisa Albert Einstein

Locations

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Instituto Israelita de Ensino e Pesquisa Albert Einstein

São Paulo, , Brazil

Site Status

Countries

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Brazil

Other Identifiers

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IIEP394-07

Identifier Type: -

Identifier Source: org_study_id

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