Transcranial Magnetic Stimulation in Episodic Migraine (Magnet-EM) (Magnet-EM)

October 31, 2022 updated by: Wan Aliaa Wan Sulaiman, Universiti Putra Malaysia

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Selangor
      • Serdang, Selangor, Malaysia, 43400
        • University Putra Malaysia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: repetitive Transcranial Magnetic Stimulation
Magstim Rapid-2 (Whitland, Walsh, UK), 70mm Double Air Film Coil given on left dorsolateral prefrontal cortex for five sessions.
Device: Repetitive Transcranial Magnetic Stimulation.
High frequency rTMS on left dorsolateral prefrontal cortex.
Other Names:
  • rTMS
Sham Comparator: 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.
Device: Sham rTMS
Sham rTMS without active magnetic coil on left dorsolateral prefrontal cortex.
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and month 1, 2 and 3 post treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and month 1, 2 and 3 post treatment
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.
Baseline and month 1, 2 and 3 post treatment
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.
During treatment and up until 1 month post treatment
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.
Baseline and at month 3 post treatment
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.
Baseline and at month 3 post treatment
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.
Baseline and at month 3 post treatment
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.
Baseline and at month 3 post treatment
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.
Baseline and at month 3 post treatment
The Food Frequency Questionnaire score in migraine patients
Time Frame: Baseline
Measuring food frequency intake at baseline
Baseline
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.
Baseline and at month 3 post treatment
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).
Baseline and at month 3 post treatment
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.
Baseline and at month 3 post treatment
Serum serotonin level in migraine patients in response to rTMS.
Time Frame: Baseline and at month 3 post treatment
Serum serotonin (ng/ml).
Baseline and at month 3 post treatment
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).
Baseline and at month 3 post treatment
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).
Baseline and at month 3 post treatment
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.
At month 3 post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiti Putra Malaysia

Investigators

  • Study Chair: Hamidon B. Basri, University Putra Malaysia
  • Study Director: Wan Aliaa B. Wan Sulaiman, MRCP, Universiti Putra Malaysia
  • Principal Investigator: Wan Aliaa B. Wan Sulaiman, MRCP, Universiti Putra Malaysia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2019

Primary Completion (Actual)

February 4, 2021

Study Completion (Actual)

April 1, 2022

Study Registration Dates

First Submitted

April 27, 2018

First Submitted That Met QC Criteria

June 13, 2018

First Posted (Actual)

June 14, 2018

Study Record Updates

Last Update Posted (Actual)

November 2, 2022

Last Update Submitted That Met QC Criteria

October 31, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GPB/2017/9585500

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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