MigraineMagnet-EMNCT03556722
Transcranial Magnetic Stimulation in Episodic Migraine (Magnet-EM)
A study testing Repetitive Transcranial Magnetic Stimulation. in people with Migraine, run by Universiti Putra Malaysia at 1 site in Malaysia.
Trial summary
This study will assess the safety and efficacy of repetitive transcranial magnetic stimulation (rTMS) as new preventive treatment of migraine. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Migraine
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation.
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteMalaysia
- Study dates
- 15 Apr 2019to 1 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
This study will assess the safety and efficacy of repetitive transcranial magnetic stimulation (rTMS) as new preventive treatment of migraine.
Read the 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.
- Conditions
- Migraine
- Being tested
- Repetitive Transcranial Magnetic Stimulation., Sham rTMS
- Keywords
- Repetitive Transcranial Magnetic Stimulation, Transcranial Doppler, Neuromodulation, Randomized Controlled Trials, Pain, Migraine prophylaxis, Dorsolateral Prefrontal Cortex, Protocol
- Medical subject headings
- Migraine Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic Stimulation.Device
Also called rTMS
High frequency rTMS on left dorsolateral prefrontal cortex.
Sham rTMSDevice
Also called Placebo
Sham rTMS without active magnetic coil on left dorsolateral prefrontal cortex.
| Study group | Role | What they receive |
|---|---|---|
| repetitive Transcranial Magnetic Stimulation | Active comparator | Magstim Rapid-2 (Whitland, Walsh, UK), 70mm Double Air Film Coil given on left dorsolateral prefrontal cortex for five sessions. Receives: Device: Repetitive Transcranial Magnetic Stimulation. |
| Sham repetitive Transcranial Magnetic Stimulation | Sham comparator | Magstim Rapid-2 (Whitland, Walsh, UK), 70mm Double Air Film Sham Coil given on left dorsolateral prefrontal cortex for five sessions. Receives: Device: Sham rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and month 1, 2 and 3 post treatment
Secondary outcomes (16)
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.
Measured: 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.
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.
Measured: Baseline and month 1, 2 and 3 post treatment
Frequency and severity of adverse events in response to rTMS.
Recorded any adverse events as per Good Clinical Practice Guideline and Declaration of Helsinki.
Measured: 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.
Mean score changes from baseline for depression, anxiety and stress category.
Measured: Baseline and at month 3 post treatment
The Migraine Disability Assessment Test (MIDAS) score changes in migraine patients in response to rTMS.
Mean score changes from baseline.
Measured: 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.
Mean score changes from baseline.
Measured: Baseline and at month 3 post treatment
The EQ-5D score changes in migraine patients in response to rTMS.
Mean score changes from baseline.
Measured: Baseline and at month 3 post treatment
The Pittsburgh Sleep Quality Index score changes in migraine in response to rTMS.
Mean score changes from baseline for sleep quality.
Measured: Baseline and at month 3 post treatment
The Food Frequency Questionnaire score in migraine patients
Measuring food frequency intake at baseline
Measured: Baseline
The Global Physical Activity Questionnaire score change in migraine in response to rTMS.
Mean score changes from baseline.
Measured: Baseline and at month 3 post treatment
Transcranial Doppler (TCD) pattern changes in migraine patients in response to rTMS.
Mean flow velocity (cm/s).
Measured: Baseline and at month 3 post treatment
Electroencephalography (EEG) pattern change in migraine patients in response to rTMS.
EEG pattern differences based on report.
Measured: Baseline and at month 3 post treatment
Serum serotonin level in migraine patients in response to rTMS.
Serum serotonin (ng/ml).
Measured: Baseline and at month 3 post treatment
Serum beta-endorphin level changes in migraine patients in response to rTMS.
Serum beta endorphin (ng/ml).
Measured: Baseline and at month 3 post treatment
Serum Calcitonin gene related peptide (CGRP) level in migraine patients in response to rTMS.
Serum CGRP (pg/ml).
Measured: Baseline and at month 3 post treatment
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.
Measured: At month 3 post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start15 Apr 2019
- Primary completion4 Feb 2021
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wan Aliaa Wan Sulaiman, Universiti Putra Malaysia
- Investigators
- Hamidon B. Basri, Study chair, Universiti Putra MalaysiaWan Aliaa B. Wan Sulaiman, MRCP, Study director, Universiti Putra MalaysiaWan Aliaa B. Wan Sulaiman, MRCP, Principal investigator, Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03556722
- Sponsor's protocol ID
- GPB/2017/9585500
- Acronym
- Magnet-EM
- Status last verified
- Oct 2022
- First submitted
- 27 Apr 2018
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33176870
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03556722
- Acronym / sponsor ID
- Magnet-EM / GPB/2017/9585500
- Conditions
- Migraine
- Keywords
- Repetitive Transcranial Magnetic Stimulation, Transcranial Doppler, Neuromodulation, Randomized Controlled Trials, Pain, Migraine prophylaxis, Dorsolateral Prefrontal Cortex, Protocol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 4 Feb 2021 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 14 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| repetitive Transcranial Magnetic Stimulation | Active comparator | Device: Repetitive Transcranial Magnetic Stimulation.Magstim Rapid-2 (Whitland, Walsh, UK), 70mm Double Air Film Coil given on left dorsolateral prefrontal cortex for five sessions. |
| Sham repetitive Transcranial Magnetic Stimulation | Sham comparator | Device: Sham rTMSMagstim Rapid-2 (Whitland, Walsh, UK), 70mm Double Air Film Sham Coil given on left dorsolateral prefrontal cortex for five sessions. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation.Also: rTMSHigh frequency rTMS on left dorsolateral prefrontal cortex. | Device | repetitive Transcranial Magnetic Stimulation |
| Sham rTMSAlso: PlaceboSham rTMS without active magnetic coil on left dorsolateral prefrontal cortex. | Device | Sham repetitive Transcranial Magnetic Stimulation |
Primary outcome
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.
16 secondary outcomes
Change from baseline in mean monthly migraine attacks.
Time frame: 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
Frequency and severity of adverse events in response to rTMS.
Time frame: 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
The Migraine Disability Assessment Test (MIDAS) score changes in migraine patients in response to rTMS.
Time frame: 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
The EQ-5D score changes in migraine patients in response to rTMS.
Time frame: 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
The Food Frequency Questionnaire score in migraine patients
Time frame: Baseline
The Global Physical Activity Questionnaire score change in migraine in response to rTMS.
Time frame: 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
Electroencephalography (EEG) pattern change in migraine patients in response to rTMS.
Time frame: 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 beta-endorphin level changes in migraine patients in response to rTMS.
Time frame: 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
Satisfaction measures of efficacy, tolerability, safety and expectations of rTMS among the participants.
Time frame: At month 3 post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Derived from this study: PubMed 33176870Mohamad 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hamidon B. Basri study chair
Universiti Putra Malaysia
Wan Aliaa B. Wan Sulaiman, MRCP study director
Universiti Putra Malaysia
Wan Aliaa B. Wan Sulaiman, MRCP principal investigator
Universiti Putra Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation. in people with Migraine, run by Universiti Putra Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in mean monthly migraine days. (time frame: Baseline and month 1, 2 and 3 post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03556722, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.