Effectiveness and tolerability of repetitive transcranial magnetic stimulation for preventive treatment of episodic migr
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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) Nabil Izzaatie Mohamad Safiai1, Nur Ain Amir1, Hamidon Basri1, Liyana Najwa Inche Mat1, Fan Kee Hoo1, Abdul Hanif Khan Yusof Khan1, Wei Chao Loh1, Peck Kee Chia1, Vasudevan Ramachandran2, Hazwan Mat Din2, Intan Nureslyna Samsudin3, Aaron Fernandez4, Mohd Hazmi Mohamed5, Siew Mooi Ching6, Hasnur Zaman Hashim7 and Wan Aliaa Wan Sulaiman1,2*
Abstract 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. (Continued on next page)
* Correspondence: [email protected] 1 Department of Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia (UPM), 43400 Serdang, Selangor, Malaysia 2 Malaysian Research Institute on Ageing, Universiti Putra Malaysia (UPM), 43400 Serdang, Selangor, Malaysia Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyrigh
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