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

Chronic Migraine Clinical Trial

— TMS-CHROMIG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01496950
• Other study ID #: IIEP394-07
• Status: Completed
• Phase: Phase 1
• First received: May 25, 2011
• Last updated: April 4, 2018
• Start date: October 2008
• Est. completion date: February 2012

Study information

• Verified date: April 2018
• Source: Hospital Israelita Albert Einstein
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: February 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Migraine
• Migraine Disorders

Intervention

Device:
• 10Hz active rTMS
10Hz active rTMS delivered to the left dorsolateral prefrontal cortex
• Placebo
10Hz placebo rTMS delivered to the vertex

Locations

Country	Name	City	State
Brazil	Instituto Israelita de Ensino e Pesquisa Albert Einstein	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Israelita Albert Einstein	Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of days with pain per month		After all treatment sessions (total, 23 sessions within 60 days)
Secondary	adverse effects		After all treatment sessions (total, 23 sessions within 60 days)