Double-blind Randomized Clinical Trial of Transcranial Magnetic Stimulation in Chronic Migraine (TMS-CHROMIG)

April 4, 2018 updated by: Adriana Conforto, Hospital Israelita Albert Einstein

Double-blind Randomized Clinical Trial to Evaluate Safety and Efficacy of Repetitive Transcranial Magnetic Stimulation in the Preventive Treatment of Chronic Migraine

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 05652901
        • Instituto Israelita de Ensino e Pesquisa Albert Einstein

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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
Active Comparator: Active Comparator: Active rTMS
10Hz active rTMS delivered to the left dorsolateral prefrontal cortex
Device: 10Hz active rTMS
10Hz active rTMS delivered to the left dorsolateral prefrontal cortex
Other Names:
  • Repetitive transcranial magnetic stimulation
Placebo Comparator: Placebo
10Hz placebo rTMS delivered to the vertex
Device: Placebo
10Hz placebo rTMS delivered to the vertex
Other Names:
  • Repetitive transcranial magnetic stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of days with pain per month
Time Frame: After all treatment sessions (total, 23 sessions within 60 days)
After all treatment sessions (total, 23 sessions within 60 days)

Secondary Outcome Measures

Outcome Measure
Time Frame
adverse effects
Time Frame: After all treatment sessions (total, 23 sessions within 60 days)
After all treatment sessions (total, 23 sessions within 60 days)

Collaborators and Investigators

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

Sponsor

Hospital Israelita Albert Einstein

Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Investigators

  • Principal Investigator: Adriana Conforto, MD,PHD, Instituto Israelita de Ensino e Pesquisa Albert Einstein

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

October 1, 2008

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

May 25, 2011

First Submitted That Met QC Criteria

December 19, 2011

First Posted (Estimate)

December 21, 2011

Study Record Updates

Last Update Posted (Actual)

April 5, 2018

Last Update Submitted That Met QC Criteria

April 4, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIEP394-07

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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