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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01496950

Acronym

TMS-CHROMIG

Enrollment

Registered

2011-12-21

Start date

2008-10-31

Completion date

2012-02-29

Last updated

2018-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Migraine

Keywords

migraine

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

Interventions

DEVICE10Hz active rTMS

10Hz active rTMS delivered to the left dorsolateral prefrontal cortex

DEVICEPlacebo

10Hz placebo rTMS delivered to the vertex

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026