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

Primary Purpose

Migraine

Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Repetitive Transcranial Magnetic Stimulation.
Sham rTMS
Sponsored by
Universiti Putra Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring Repetitive Transcranial Magnetic Stimulation, Transcranial Doppler, Neuromodulation, Randomized Controlled Trials, Pain, Migraine prophylaxis, Dorsolateral Prefrontal Cortex, Protocol

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • University Putra Malaysia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

repetitive Transcranial Magnetic Stimulation

Sham repetitive Transcranial Magnetic Stimulation

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change from baseline in mean monthly migraine days.
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 Outcome Measures

Change from baseline in mean monthly migraine attacks.
The mean monthly migraine attacks will be calculated using the monthly migraine attack from each of the month of the double-blind treatment phase.
Proportion of subjects with at least a 50% reduction from baseline in mean monthly migraine days.
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.
Frequency and severity of adverse events in response to rTMS.
Recorded any adverse events as per Good Clinical Practice Guideline and Declaration of Helsinki.
The Depression Anxiety Stress Scale (DASS 21) score changes in migraine patients in response to rTMS.
Mean score changes from baseline for depression, anxiety and stress category.
The Migraine Disability Assessment Test (MIDAS) score changes in migraine patients in response to rTMS.
Mean score changes from baseline.
The Migraine Specific Questionnaire (MSQ) version 2.1 score changes in migraine patients in response to r-TMS.
Mean score changes from baseline.
The EQ-5D score changes in migraine patients in response to rTMS.
Mean score changes from baseline.
The Pittsburgh Sleep Quality Index score changes in migraine in response to rTMS.
Mean score changes from baseline for sleep quality.
The Food Frequency Questionnaire score in migraine patients
Measuring food frequency intake at baseline
The Global Physical Activity Questionnaire score change in migraine in response to rTMS.
Mean score changes from baseline.
Transcranial Doppler (TCD) pattern changes in migraine patients in response to rTMS.
Mean flow velocity (cm/s).
Electroencephalography (EEG) pattern change in migraine patients in response to rTMS.
EEG pattern differences based on report.
Serum serotonin level in migraine patients in response to rTMS.
Serum serotonin (ng/ml).
Serum beta-endorphin level changes in migraine patients in response to rTMS.
Serum beta endorphin (ng/ml).
Serum Calcitonin gene related peptide (CGRP) level in migraine patients in response to rTMS.
Serum CGRP (pg/ml).
Satisfaction measures of efficacy, tolerability, safety and expectations of rTMS among the participants.
A 5-point, Likert scale will be used to evaluate satisfaction with rTMS in migraine prevention.

Full Information

First Posted
April 27, 2018
Last Updated
October 31, 2022
Sponsor
Universiti Putra Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT03556722
Brief Title
Transcranial Magnetic Stimulation in Episodic Migraine (Magnet-EM)
Acronym
Magnet-EM
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
April 15, 2019 (Actual)
Primary Completion Date
February 4, 2021 (Actual)
Study Completion Date
April 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Putra Malaysia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Repetitive Transcranial Magnetic Stimulation, Transcranial Doppler, Neuromodulation, Randomized Controlled Trials, Pain, Migraine prophylaxis, Dorsolateral Prefrontal Cortex, Protocol

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two-arm parallel assignment involves two groups of participants. One group receives r-TMS, and the other group receives sham placebo r-TMS.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double blinded
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
repetitive Transcranial Magnetic Stimulation
Arm Type
Active Comparator
Arm Description
Magstim Rapid-2 (Whitland, Walsh, UK), 70mm Double Air Film Coil given on left dorsolateral prefrontal cortex for five sessions.
Arm Title
Sham repetitive Transcranial Magnetic Stimulation
Arm Type
Sham Comparator
Arm Description
Magstim Rapid-2 (Whitland, Walsh, UK), 70mm Double Air Film Sham Coil given on left dorsolateral prefrontal cortex for five sessions.
Intervention Type
Device
Intervention Name(s)
Repetitive Transcranial Magnetic Stimulation.
Other Intervention Name(s)
rTMS
Intervention Description
High frequency rTMS on left dorsolateral prefrontal cortex.
Intervention Type
Device
Intervention Name(s)
Sham rTMS
Other Intervention Name(s)
Placebo
Intervention Description
Sham rTMS without active magnetic coil on left dorsolateral prefrontal cortex.
Primary Outcome Measure Information:
Title
Change from baseline in mean monthly migraine days.
Description
The mean monthly migraine days will be calculated using the monthly migraine days from each of the month of the double-blind treatment phase.
Time Frame
Baseline and month 1, 2 and 3 post treatment
Secondary Outcome Measure Information:
Title
Change from baseline in mean monthly migraine attacks.
Description
The mean monthly migraine attacks will be calculated using the monthly migraine attack from each of the month of the double-blind treatment phase.
Time Frame
Baseline and month 1, 2 and 3 post treatment
Title
Proportion of subjects with at least a 50% reduction from baseline in mean monthly migraine days.
Description
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.
Time Frame
Baseline and month 1, 2 and 3 post treatment
Title
Frequency and severity of adverse events in response to rTMS.
Description
Recorded any adverse events as per Good Clinical Practice Guideline and Declaration of Helsinki.
Time Frame
During treatment and up until 1 month post treatment
Title
The Depression Anxiety Stress Scale (DASS 21) score changes in migraine patients in response to rTMS.
Description
Mean score changes from baseline for depression, anxiety and stress category.
Time Frame
Baseline and at month 3 post treatment
Title
The Migraine Disability Assessment Test (MIDAS) score changes in migraine patients in response to rTMS.
Description
Mean score changes from baseline.
Time Frame
Baseline and at month 3 post treatment
Title
The Migraine Specific Questionnaire (MSQ) version 2.1 score changes in migraine patients in response to r-TMS.
Description
Mean score changes from baseline.
Time Frame
Baseline and at month 3 post treatment
Title
The EQ-5D score changes in migraine patients in response to rTMS.
Description
Mean score changes from baseline.
Time Frame
Baseline and at month 3 post treatment
Title
The Pittsburgh Sleep Quality Index score changes in migraine in response to rTMS.
Description
Mean score changes from baseline for sleep quality.
Time Frame
Baseline and at month 3 post treatment
Title
The Food Frequency Questionnaire score in migraine patients
Description
Measuring food frequency intake at baseline
Time Frame
Baseline
Title
The Global Physical Activity Questionnaire score change in migraine in response to rTMS.
Description
Mean score changes from baseline.
Time Frame
Baseline and at month 3 post treatment
Title
Transcranial Doppler (TCD) pattern changes in migraine patients in response to rTMS.
Description
Mean flow velocity (cm/s).
Time Frame
Baseline and at month 3 post treatment
Title
Electroencephalography (EEG) pattern change in migraine patients in response to rTMS.
Description
EEG pattern differences based on report.
Time Frame
Baseline and at month 3 post treatment
Title
Serum serotonin level in migraine patients in response to rTMS.
Description
Serum serotonin (ng/ml).
Time Frame
Baseline and at month 3 post treatment
Title
Serum beta-endorphin level changes in migraine patients in response to rTMS.
Description
Serum beta endorphin (ng/ml).
Time Frame
Baseline and at month 3 post treatment
Title
Serum Calcitonin gene related peptide (CGRP) level in migraine patients in response to rTMS.
Description
Serum CGRP (pg/ml).
Time Frame
Baseline and at month 3 post treatment
Title
Satisfaction measures of efficacy, tolerability, safety and expectations of rTMS among the participants.
Description
A 5-point, Likert scale will be used to evaluate satisfaction with rTMS in migraine prevention.
Time Frame
At month 3 post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hamidon B. Basri
Organizational Affiliation
University Putra Malaysia
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Wan Aliaa B. Wan Sulaiman, MRCP
Organizational Affiliation
Universiti Putra Malaysia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Wan Aliaa B. Wan Sulaiman, MRCP
Organizational Affiliation
Universiti Putra Malaysia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Putra Malaysia
City
Serdang
State/Province
Selangor
ZIP/Postal Code
43400
Country
Malaysia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33176870
Citation
Mohamad Safiai NI, Amir NA, Basri H, Inche Mat LN, Hoo FK, Yusof Khan AHK, Loh WC, Chia PK, Ramachandran V, Mat Din H, Samsudin IN, Fernandez A, Mohamed MH, Ching SM, Hashim HZ, Wan Sulaiman WA. 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 (Magnet-EM). Trials. 2020 Nov 11;21(1):923. doi: 10.1186/s13063-020-04832-y.
Results Reference
derived

Learn more about this trial

Transcranial Magnetic Stimulation in Episodic Migraine (Magnet-EM)

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