Transcranial Magnetic Stimulation in Episodic Migraine (Magnet-EM)

University of Putra Malaysia (UPM)

Status: Completed

Conditions: Migraine

Treatments: Device: Sham rTMS; Device: Repetitive Transcranial Magnetic Stimulation.

Study type: Interventional

Funder types: Other

Identifiers

NCT03556722

GPB/2017/9585500

Details and patient eligibility

About

This study will assess the safety and efficacy of repetitive transcranial magnetic stimulation (rTMS) as new preventive treatment of migraine.

Full description

Migraine patients according to International Headache Society criteria will be allocated randomly into two treatment arms. One group will receive active rTMS and another group will receive sham rTMS for treatment phase (5 sessions). Assessment will be made at baseline, month 1, month 2 and month 3 post-treatment.

Enrollment: 76 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Males or females aged 18 to 60 years of age.
2. Subjects fulfilling criteria for episodic migraine as per the Third Edition of The International Headache Society (ICHD-3) for at least 1 year.
3. Frequency of migraine attacks 2-8 times per month with less than 15 headache days per month for at least 3 months prior to screening.
4. Demonstrated compliance with the headache diary during the run-in period by entry of headache data on a minimum of 24/30 days (80% compliance).
5. A signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study including any known and potential risks and available alternative treatments.

Exclusion criteria

1. Patients with previous history of rTMS treatment.
2. Onset of headache at more than 50-year-old.
3. Headache with red flags symptoms that may suggest organic secondary headaches.
4. Pregnant or lactating women.
5. Patients with contraindications to TMS such as metallic implant and pacemaker based on the Screening 13-item Questionnaire for rTMS candidate.
6. Patients with medical conditions such severe hypertension, infections, malignancy, cardiovascular and cerebrovascular disease, epilepsy degenerative central nervous system diseases, renal failure, hepatic failure, bleeding diathesis and serious mental illness.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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76 participants in 2 patient groups

repetitive Transcranial Magnetic Stimulation

Active Comparator group

Description:

Magstim Rapid-2 (Whitland, Walsh, UK), 70mm Double Air Film Coil given on left dorsolateral prefrontal cortex for five sessions.

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation.

Sham repetitive Transcranial Magnetic Stimulation

Sham Comparator group

Description:

Magstim Rapid-2 (Whitland, Walsh, UK), 70mm Double Air Film Sham Coil given on left dorsolateral prefrontal cortex for five sessions.

Treatment:

Device: Sham rTMS