Transcranial Magnetic Stimulation in Episodic Migraine (Magnet-EM)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-15

Study Completion Date

2022-04-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two-arm parallel assignment involves two groups of participants. One group receives r-TMS, and the other group receives sham placebo r-TMS.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double blinded

Study Groups

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repetitive Transcranial Magnetic Stimulation

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

Group Type ACTIVE_COMPARATOR

Repetitive Transcranial Magnetic Stimulation.

Intervention Type DEVICE

High frequency rTMS on left dorsolateral prefrontal cortex.

Sham repetitive Transcranial Magnetic Stimulation

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

Group Type SHAM_COMPARATOR

Sham rTMS

Intervention Type DEVICE

Sham rTMS without active magnetic coil on left dorsolateral prefrontal cortex.

Interventions

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Repetitive Transcranial Magnetic Stimulation.

High frequency rTMS on left dorsolateral prefrontal cortex.

Intervention Type DEVICE

Sham rTMS

Sham rTMS without active magnetic coil on left dorsolateral prefrontal cortex.

Intervention Type DEVICE

Other Intervention Names

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rTMS Placebo

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No