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

Hospital Israelita Albert Einstein

Status and phase

Completed

Phase 1

Conditions

Chronic Migraine

Treatments

Device: 10Hz active rTMS

Device: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01496950

IIEP394-07

Details and patient eligibility

About

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.

Full 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

Enrollment

18 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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