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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Hospital Israelita Albert Einstein.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Adriana Conforto, Hospital Israelita Albert Einstein
ClinicalTrials.gov Identifier:
NCT01496950
First received: May 25, 2011
Last updated: December 19, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Chronic Migraine
Device: 10Hz active rTMS
Device: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-blind Randomized Clinical Trial to Evaluate Safety and Efficacy of Repetitive Transcranial Magnetic Stimulation in the Preventive Treatment of Chronic Migraine

Resource links provided by NLM:


Further study details as provided by Hospital Israelita Albert Einstein:

Primary Outcome Measures:
  • number of days with pain per month [ Time Frame: After all treatment sessions (total, 23 sessions within 60 days) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • adverse effects [ Time Frame: After all treatment sessions (total, 23 sessions within 60 days) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: October 2008
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Repetitive transcranial magnetic stimulation
Placebo Comparator: Placebo
10Hz placebo rTMS delivered to the vertex
Device: Placebo
10Hz placebo rTMS delivered to the vertex
Other Name: Repetitive transcranial magnetic stimulation

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01496950

Contacts
Contact: Adriana Conforto, MD,PhD adriana.conforto@gmail.com

Locations
Brazil
Instituto Israelita de Ensino e Pesquisa Albert Einstein Recruiting
São Paulo, Brazil, 05652901
Contact: Adriana Conforto, MD, PhD       adriana.conforto@gmail.com   
Sub-Investigator: Mario Fernando P Peres, MD,PhD         
Sub-Investigator: Edson Amaro Jr, MD, PHD         
Sponsors and Collaborators
Hospital Israelita Albert Einstein
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
Principal Investigator: Adriana Conforto, MD,PHD Instituto Israelita de Ensino e Pesquisa Albert Einstein
  More Information

No publications provided

Responsible Party: Adriana Conforto, Professor of Neurology, MD PhD, Hospital Israelita Albert Einstein
ClinicalTrials.gov Identifier: NCT01496950     History of Changes
Other Study ID Numbers: IIEP394-07
Study First Received: May 25, 2011
Last Updated: December 19, 2011
Health Authority: Brazil: Ethics Committee

Keywords provided by Hospital Israelita Albert Einstein:
migraine

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 18, 2014