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

Phase 1

Completed

• Conditions: Chronic Migraine
• Interventions: Device: 10Hz active rTMS; Device: Placebo

• Registration Number: NCT01496950
• Lead Sponsor: Hospital Israelita Albert Einstein

Brief 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.

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 Timeline

• Study Start: 2008-10
• Study First Submitted: 2011-05-25
• Primary Completion: 2011-12
• Study First Submitted QC: 2011-12-19
• Study First Posted: 2011-12-21
• Study Completion: 2012-02
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-04
• Last Update Posted: 2018-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Comparator: Active rTMS	10Hz active rTMS	10Hz active rTMS delivered to the left dorsolateral prefrontal cortex
Placebo	Placebo	10Hz placebo rTMS delivered to the vertex

Primary Outcome Measures

Name	Time	Method
number of days with pain per month	After all treatment sessions (total, 23 sessions within 60 days)

Secondary Outcome Measures

Name	Time	Method
adverse effects	After all treatment sessions (total, 23 sessions within 60 days)

Trial Locations

Locations (1)

Instituto Israelita de Ensino e Pesquisa Albert Einstein; 🇧🇷 São Paulo, Brazil