Transcranial Magnetic Stimulation in Episodic Migraine (Magnet-EM)
Magnet-EM
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
1 other identifier
interventional
76
1 country
1
Brief Summary
This study will assess the safety and efficacy of repetitive transcranial magnetic stimulation (rTMS) as new preventive treatment of migraine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2018
CompletedFirst Posted
Study publicly available on registry
June 14, 2018
CompletedStudy Start
First participant enrolled
April 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 4, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2022
CompletedNovember 2, 2022
October 1, 2022
1.8 years
April 27, 2018
October 31, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline and month 1, 2 and 3 post treatment
Secondary Outcomes (16)
Change from baseline in mean monthly migraine attacks.
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.
Baseline and month 1, 2 and 3 post treatment
Frequency and severity of adverse events in response to rTMS.
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.
Baseline and at month 3 post treatment
The Migraine Disability Assessment Test (MIDAS) score changes in migraine patients in response to rTMS.
Baseline and at month 3 post treatment
- +11 more secondary outcomes
Study Arms (2)
repetitive Transcranial Magnetic Stimulation
ACTIVE COMPARATORMagstim 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 COMPARATORMagstim Rapid-2 (Whitland, Walsh, UK), 70mm Double Air Film Sham Coil given on left dorsolateral prefrontal cortex for five sessions.
Interventions
High frequency rTMS on left dorsolateral prefrontal cortex.
Sham rTMS without active magnetic coil on left dorsolateral prefrontal cortex.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Putra Malaysia
Serdang, Selangor, 43400, Malaysia
Related Publications (1)
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.
PMID: 33176870DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double blinded
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
April 27, 2018
First Posted
June 14, 2018
Study Start
April 15, 2019
Primary Completion
February 4, 2021
Study Completion
April 1, 2022
Last Updated
November 2, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share