Skip to main content
OpenTrials
Completed

NCT Number: NCT03556722

Transcranial Magnetic Stimulation in Episodic Migraine (Magnet-EM)

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Putra Malaysia

Serdang, Selangor, 43400, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males or females aged 18 to 60 years of age.
  • Subjects fulfilling criteria for episodic migraine as per the Third Edition of The International Headache Society (ICHD-3) for at least 1 year.
  • 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.
  • 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).
  • 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

  • Patients with previous history of rTMS treatment.
  • Onset of headache at more than 50-year-old.
  • Headache with red flags symptoms that may suggest organic secondary headaches.
  • Pregnant or lactating women.
  • Patients with contraindications to TMS such as metallic implant and pacemaker based on the Screening 13-item Questionnaire for rTMS candidate.
  • 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.

Treatment and study plan

Repetitive Transcranial Magnetic Stimulation.

Device

High frequency rTMS on left dorsolateral prefrontal cortex.

Other names: rTMS

sham rTMS

Device

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

Other names: Placebo

Primary outcomes

  1. Change from baseline in mean monthly migraine days.

    Time frame: Baseline and month 1, 2 and 3 post treatment

    The mean monthly migraine days will be calculated using the monthly migraine days from each of the month of the double-blind treatment phase.

Secondary outcomes

  1. Change from baseline in mean monthly migraine attacks.

    Time frame: Baseline and month 1, 2 and 3 post treatment

    The mean monthly migraine attacks will be calculated using the monthly migraine attack from each of the month of the double-blind treatment phase.

  2. Proportion of subjects with at least a 50% reduction from baseline in mean monthly migraine days.

    Time frame: Baseline and month 1, 2 and 3 post treatment

    Change from baseline in mean monthly pain intensity of migraine attacks. The mean monthly pain intensity will be based on the record of the maximal pain intensity by means of a verbal scale (i.e. 0 =no headache; 1 = mild headache; 2 = moderate headache; 3 = severe headache) prior to taking symptomatic medication.

  3. Frequency and severity of adverse events in response to rTMS.

    Time frame: During treatment and up until 1 month post treatment

    Recorded any adverse events as per Good Clinical Practice Guideline and Declaration of Helsinki.

  4. The Depression Anxiety Stress Scale (DASS 21) score changes in migraine patients in response to rTMS.

    Time frame: Baseline and at month 3 post treatment

    Mean score changes from baseline for depression, anxiety and stress category.

  5. The Migraine Disability Assessment Test (MIDAS) score changes in migraine patients in response to rTMS.

    Time frame: Baseline and at month 3 post treatment

    Mean score changes from baseline.

  6. The Migraine Specific Questionnaire (MSQ) version 2.1 score changes in migraine patients in response to r-TMS.

    Time frame: Baseline and at month 3 post treatment

    Mean score changes from baseline.

  7. The EQ-5D score changes in migraine patients in response to rTMS.

    Time frame: Baseline and at month 3 post treatment

    Mean score changes from baseline.

  8. The Pittsburgh Sleep Quality Index score changes in migraine in response to rTMS.

    Time frame: Baseline and at month 3 post treatment

    Mean score changes from baseline for sleep quality.

  9. The Food Frequency Questionnaire score in migraine patients

    Time frame: Baseline

    Measuring food frequency intake at baseline

  10. The Global Physical Activity Questionnaire score change in migraine in response to rTMS.

    Time frame: Baseline and at month 3 post treatment

    Mean score changes from baseline.

  11. Transcranial Doppler (TCD) pattern changes in migraine patients in response to rTMS.

    Time frame: Baseline and at month 3 post treatment

    Mean flow velocity (cm/s).

  12. Electroencephalography (EEG) pattern change in migraine patients in response to rTMS.

    Time frame: Baseline and at month 3 post treatment

    EEG pattern differences based on report.

  13. Serum serotonin level in migraine patients in response to rTMS.

    Time frame: Baseline and at month 3 post treatment

    Serum serotonin (ng/ml).

  14. Serum beta-endorphin level changes in migraine patients in response to rTMS.

    Time frame: Baseline and at month 3 post treatment

    Serum beta endorphin (ng/ml).

  15. Serum Calcitonin gene related peptide (CGRP) level in migraine patients in response to rTMS.

    Time frame: Baseline and at month 3 post treatment

    Serum CGRP (pg/ml).

  16. Satisfaction measures of efficacy, tolerability, safety and expectations of rTMS among the participants.

    Time frame: At month 3 post treatment

    A 5-point, Likert scale will be used to evaluate satisfaction with rTMS in migraine prevention.

Sponsors and collaborators

Lead sponsor

Universiti Putra Malaysia

Other

Registry information

Official study title

Effectiveness and Tolerability of Repetitive Transcranial Magnetic Stimulation For Preventive Treatment Of Episodic Migraine: A Single Centre, Randomised, Double-Blind, Sham-Controlled Phase 2 Trial

Acronym: Magnet-EM

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Jun 14, 2018
Registry last updated
Nov 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.