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 Safiai,
Nur Ain Amir,
Hamidon Basri,
Liyana Najwa Inche Mat,
Fan Kee Hoo,
Abdul Hanif Khan Yusof Khan,
Wei Chao Loh,
Peck Kee Chia,
Vasudevan Ramachandran,
Hazwan Mat Din,
Intan Nureslyna Samsudin,
Aaron Fernandez,
Mohd Hazmi Mohamed,
Siew Mooi Ching,
Hasnur Zaman Hashim,
Wan Aliaa Wan Sulaiman
Affiliations
Nabil Izzaatie Mohamad Safiai
Department of Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia (UPM)
Nur Ain Amir
Department of Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia (UPM)
Hamidon Basri
Department of Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia (UPM)
Liyana Najwa Inche Mat
Department of Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia (UPM)
Fan Kee Hoo
Department of Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia (UPM)
Abdul Hanif Khan Yusof Khan
Department of Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia (UPM)
Wei Chao Loh
Department of Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia (UPM)
Peck Kee Chia
Department of Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia (UPM)
Vasudevan Ramachandran
Malaysian Research Institute on Ageing, Universiti Putra Malaysia (UPM)
Hazwan Mat Din
Malaysian Research Institute on Ageing, Universiti Putra Malaysia (UPM)
Intan Nureslyna Samsudin
Department of Pathology, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia (UPM)
Aaron Fernandez
Department of Psychiatry, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia (UPM)
Mohd Hazmi Mohamed
Department of ORL-HNS, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia (UPM)
Siew Mooi Ching
Department of Family Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia (UPM)
Hasnur Zaman Hashim
Neurology services, Columbia Asia Hospital-Klang
Wan Aliaa Wan Sulaiman
Department of Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia (UPM)
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. 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. Trial registration ClinicalTrials.gov NCT03556722 . Registered on 14 June 2018
