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This study will assess the safety and efficacy of repetitive transcranial magnetic stimulation (rTMS) as new preventive treatment of migraine.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repetitive Transcranial Magnetic Stimulation. | Device | High frequency rTMS on left dorsolateral prefrontal cortex. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hamidon B. Basri | University Putra Malaysia | Study Chair |
| Wan Aliaa B. Wan Sulaiman, MRCP | Universiti Putra Malaysia | Study Director |
| Wan Aliaa B. Wan Sulaiman, MRCP | Universiti Putra Malaysia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Putra Malaysia | Serdang | Selangor | 43400 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33176870 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 16, 2023 | |
| Reset | Mar 21, 2024 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 1, 2019 | Apr 30, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 11, 2020 | May 6, 2021 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 29, 2019 | Apr 30, 2021 | ICF_002.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 16, 2023 | Mar 21, 2024 |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D010146 | Pain |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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Two-arm parallel assignment involves two groups of participants. One group receives r-TMS, and the other group receives sham placebo r-TMS.
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Double blinded
| Sham rTMS | Device | Sham rTMS without active magnetic coil on left dorsolateral prefrontal cortex. |
|
|
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. | 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. | 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. | 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. | Mean score changes from baseline. | Baseline and at month 3 post treatment |
| The EQ-5D score changes in migraine patients in response to rTMS. | 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. | Mean score changes from baseline for sleep quality. | Baseline and at month 3 post treatment |
| The Food Frequency Questionnaire score in migraine patients | Measuring food frequency intake at baseline | Baseline |
| The Global Physical Activity Questionnaire score change in migraine in response to rTMS. | Mean score changes from baseline. | Baseline and at month 3 post treatment |
| Transcranial Doppler (TCD) pattern changes in migraine patients in response to rTMS. | Mean flow velocity (cm/s). | Baseline and at month 3 post treatment |
| Electroencephalography (EEG) pattern change in migraine patients in response to rTMS. | EEG pattern differences based on report. | Baseline and at month 3 post treatment |
| Serum serotonin level in migraine patients in response to rTMS. | Serum serotonin (ng/ml). | Baseline and at month 3 post treatment |
| Serum beta-endorphin level changes in migraine patients in response to rTMS. | 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. | Serum CGRP (pg/ml). | 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. | At month 3 post treatment |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |