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Completed

NCT Number: NCT01496950

Double-blind Randomized Clinical Trial of Transcranial Magnetic Stimulation in 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.

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Key information

Conditions

Chronic Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Instituto Israelita de Ensino e Pesquisa Albert Einstein

São Paulo, 05652901, Brazil

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

10Hz active rTMS

Device

10Hz active rTMS delivered to the left dorsolateral prefrontal cortex

Other names: Repetitive transcranial magnetic stimulation

PLACEBO

Device

10Hz placebo rTMS delivered to the vertex

Other names: Repetitive transcranial magnetic stimulation

Primary outcomes

  1. number of days with pain per month

    Time frame: After all treatment sessions (total, 23 sessions within 60 days)

Secondary outcomes

  1. adverse effects

    Time frame: After all treatment sessions (total, 23 sessions within 60 days)

Sponsors and collaborators

Lead sponsor

Hospital Israelita Albert Einstein

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

Registry information

Official study title

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

Acronym: TMS-CHROMIG

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
Dec 21, 2011
Registry last updated
Apr 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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