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)
Background: This is a phase II randomised, double-blind, sham-controlled trial to evaluate the effectiveness and tolerability of repetitive transcranial magnetic stimulation for preventive treatment of episodic migraine amongst migraine subjects. Methods: Subjects age 18 to 60 years will undergo a...
| Main Authors: | , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BioMed Central
2020
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| Online Access: | http://psasir.upm.edu.my/id/eprint/88664/ http://psasir.upm.edu.my/id/eprint/88664/1/ABSTRACT.pdf |
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| author | Mohamad Safiai, Nabil Izzaatie Amir, Nur Ain Basri, Hamidon Inche Mat, Liyana Najwa Hoo, Fan Kee Yusof Khan, Abdul Hanif Khan Loh, Wei Chao Chia, Peck Kee Ramachandran, Vasudevan Mat Din, Hazwan Samsudin, Intan Nureslyna Fernandez, Aaron Mohamed, Mohd Hazmi Ching, Siew Mooi Hashim, Hasnur Zaman Wan Sulaiman, Wan Aliaa |
| author_facet | Mohamad Safiai, Nabil Izzaatie Amir, Nur Ain Basri, Hamidon Inche Mat, Liyana Najwa Hoo, Fan Kee Yusof Khan, Abdul Hanif Khan Loh, Wei Chao Chia, Peck Kee Ramachandran, Vasudevan Mat Din, Hazwan Samsudin, Intan Nureslyna Fernandez, Aaron Mohamed, Mohd Hazmi Ching, Siew Mooi Hashim, Hasnur Zaman Wan Sulaiman, Wan Aliaa |
| author_sort | Mohamad Safiai, Nabil Izzaatie |
| building | UPM Institutional Repository |
| collection | Online Access |
| description | Background: This is a phase II randomised, double-blind, sham-controlled trial to evaluate the effectiveness and
tolerability of repetitive transcranial magnetic stimulation for preventive treatment of episodic migraine amongst
migraine subjects. Methods: Subjects age 18 to 60 years will undergo a baseline evaluation to establish the diagnosis of migraine based on the International Classification of Headache Disorder 3rd Edition (ICHD-3). Those who fulfil the ICHD-3 criteria for episodic migraine and compliant to the headache diary during a month run-in period will be enrolled. A total of 76 subjects will be randomised to receive either transcranial magnetic stimulation or sham stimulation for 5 sessions within 2 weeks duration. Follow-up sessions will be conducted monthly for three consecutive months. Prior to treatment, subjects will be required to fill up questionnaires and undergo few procedures such as
electroencephalography, transcranial Doppler ultrasound and biochemical analysis for serum serotonin, serum calcitonin gene-related peptide and serum beta-endorphin. These procedures will be repeated at month 3 after receiving the last treatment. The primary outcome measure of this study is the difference in mean monthly migraine days at baseline and at months 1, 2 and 3 after treatment sessions. Discussion: Following evidence from previous studies showing restoration of dorsolateral prefrontal cortex (DLPFC) activation to almost normal level, the rTMS intervention will target left DLPFC in this study. An intermediate duration of treatment sessions is selected for this study. It is set to five treatment sessions given within 2 weeks duration. |
| first_indexed | 2025-11-15T12:48:54Z |
| format | Article |
| id | upm-88664 |
| institution | Universiti Putra Malaysia |
| institution_category | Local University |
| language | English |
| last_indexed | 2025-11-15T12:48:54Z |
| publishDate | 2020 |
| publisher | BioMed Central |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | upm-886642021-12-14T23:51:27Z http://psasir.upm.edu.my/id/eprint/88664/ 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) Mohamad Safiai, Nabil Izzaatie Amir, Nur Ain Basri, Hamidon Inche Mat, Liyana Najwa Hoo, Fan Kee Yusof Khan, Abdul Hanif Khan Loh, Wei Chao Chia, Peck Kee Ramachandran, Vasudevan Mat Din, Hazwan Samsudin, Intan Nureslyna Fernandez, Aaron Mohamed, Mohd Hazmi Ching, Siew Mooi Hashim, Hasnur Zaman Wan Sulaiman, Wan Aliaa Background: This is a phase II randomised, double-blind, sham-controlled trial to evaluate the effectiveness and tolerability of repetitive transcranial magnetic stimulation for preventive treatment of episodic migraine amongst migraine subjects. Methods: Subjects age 18 to 60 years will undergo a baseline evaluation to establish the diagnosis of migraine based on the International Classification of Headache Disorder 3rd Edition (ICHD-3). Those who fulfil the ICHD-3 criteria for episodic migraine and compliant to the headache diary during a month run-in period will be enrolled. A total of 76 subjects will be randomised to receive either transcranial magnetic stimulation or sham stimulation for 5 sessions within 2 weeks duration. Follow-up sessions will be conducted monthly for three consecutive months. Prior to treatment, subjects will be required to fill up questionnaires and undergo few procedures such as electroencephalography, transcranial Doppler ultrasound and biochemical analysis for serum serotonin, serum calcitonin gene-related peptide and serum beta-endorphin. These procedures will be repeated at month 3 after receiving the last treatment. The primary outcome measure of this study is the difference in mean monthly migraine days at baseline and at months 1, 2 and 3 after treatment sessions. Discussion: Following evidence from previous studies showing restoration of dorsolateral prefrontal cortex (DLPFC) activation to almost normal level, the rTMS intervention will target left DLPFC in this study. An intermediate duration of treatment sessions is selected for this study. It is set to five treatment sessions given within 2 weeks duration. BioMed Central 2020 Article PeerReviewed text en http://psasir.upm.edu.my/id/eprint/88664/1/ABSTRACT.pdf Mohamad Safiai, Nabil Izzaatie and Amir, Nur Ain and Basri, Hamidon and Inche Mat, Liyana Najwa and Hoo, Fan Kee and Yusof Khan, Abdul Hanif Khan and Loh, Wei Chao and Chia, Peck Kee and Ramachandran, Vasudevan and Mat Din, Hazwan and Samsudin, Intan Nureslyna and Fernandez, Aaron and Mohamed, Mohd Hazmi and Ching, Siew Mooi and Hashim, Hasnur Zaman and Wan Sulaiman, Wan Aliaa (2020) 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, 21. art. no. 923. pp. 1-9. ISSN 1745-6215 https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-020-04832-y 10.1186/s13063-020-04832-y |
| spellingShingle | Mohamad Safiai, Nabil Izzaatie Amir, Nur Ain Basri, Hamidon Inche Mat, Liyana Najwa Hoo, Fan Kee Yusof Khan, Abdul Hanif Khan Loh, Wei Chao Chia, Peck Kee Ramachandran, Vasudevan Mat Din, Hazwan Samsudin, Intan Nureslyna Fernandez, Aaron Mohamed, Mohd Hazmi Ching, Siew Mooi Hashim, Hasnur Zaman Wan Sulaiman, Wan Aliaa 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) |
| 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 (Magnet-EM) |
| title_full | 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) |
| title_fullStr | 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) |
| title_full_unstemmed | 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) |
| title_short | 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) |
| title_sort | 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) |
| url | http://psasir.upm.edu.my/id/eprint/88664/ http://psasir.upm.edu.my/id/eprint/88664/ http://psasir.upm.edu.my/id/eprint/88664/ http://psasir.upm.edu.my/id/eprint/88664/1/ABSTRACT.pdf |