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, 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

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.

Keywords: Migraine; Randomised controlled trial; Repetitive transcranial magnetic stimulation (TMS).

Figures

Fig. 1
Fig. 1
The overall design of the study. V, visit; M, month

References

    1. Stovner L, Hagen K, Jensen R, Katsarava Z, Lipton R, Scher A, et al. The global burden of headache: a documentation of headache prevalence and disability worldwide. Cephalalgia. 2007;27(3):193–210. doi: 10.1111/j.1468-2982.2007.01288.x.
    1. Peng KP, Wang SJ. Epidemiology of headache disorders in the Asia-pacific Region. Headache. 2014;54:610–618. doi: 10.1111/head.12328.
    1. Goadsby PJ, Lipton RB, Ferrari MD. Migraine—current understanding and treatment. N Engl J Med. 2002;346:257–270. doi: 10.1056/NEJMra010917.
    1. Rossi S, Hallett M, Rossini PM, Pascual-Leone A, Safety of TMSCG Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol. 2009;120(12):2008–2039. doi: 10.1016/j.clinph.2009.08.016.
    1. Barker AT, Jalinous R, Freeston IL. Non-invasive magnetic stimulation of human motor cortex. Lancet (London, England) 1985;1(8437):1106–1107. doi: 10.1016/S0140-6736(85)92413-4.
    1. Machii K, Cohen D, Ramos-Estebanez C, Pascual-Leone A. Safety of rTMS to non-motor cortical areas in healthy participants and patients. Clin Neurophysiol. 2006;117(2):455–471. doi: 10.1016/j.clinph.2005.10.014.
    1. Lan L, Zhang X, Li X, Rong X, Peng Y. The efficacy of transcranial magnetic stimulation on migraine: a meta-analysis of randomized controlled trails. J Headache Pain. 2017;18(1):86. doi: 10.1186/s10194-017-0792-4.
    1. Kumar S, Singh S, Kumar N, Verma R. The effects of repetitive transcranial magnetic stimulation at dorsolateral prefrontal cortex in the treatment of migraine comorbid with depression: a retrospective open study. Clin Psychopharmacol Neurosci. 2018;16(1):62–66. doi: 10.9758/cpn.2018.16.1.62.
    1. Stilling JM, Monchi O, Amoozegar F, Debert CT. Transcranial magnetic and direct current stimulation (TMS/tDCS) for the treatment of headache: a systematic review. Headache. 2019;59(3):339–357. doi: 10.1111/head.13479.
    1. Brighina F, Piazza A, Vitello G, Aloisio A, Palermo A, Daniele O, et al. rTMS of the prefrontal cortex in the treatment of chronic migraine: a pilot study. J Neurol Sci. 2004;227(1):67–71. doi: 10.1016/j.jns.2004.08.008.
    1. Conforto AB, Amaro E, Jr, Goncalves AL, Mercante JP, Guendler VZ, Ferreira JR, et al. Randomized, proof-of-principle clinical trial of active transcranial magnetic stimulation in chronic migraine. Cephalalgia. 2014;34(6):464–472. doi: 10.1177/0333102413515340.
    1. Tfelt-Hansen P, Block G, Dahlöf C, Diener HC, Ferrari MD, Goadsby PJ, et al. Guidelines for controlled trials of drugs in migraine: second edition. Cephalalgia. 2000;20(9):765–786. doi: 10.1046/j.1468-2982.2000.00117.x.
    1. Misra UK, Kalita J, Bhoi SK. High-rate repetitive transcranial magnetic stimulation in migraine prophylaxis: a randomized, placebo-controlled study. J Neurol. 2013;260(11):2793–2801. doi: 10.1007/s00415-013-7072-2.
    1. Janicak PG, O’Reardon JP, Sampson SM, Husain MM, Lisanby SH, Rado JT, et al. Transcranial magnetic stimulation in the treatment of major depressive disorder: a comprehensive summary of safety experience from acute exposure, extended exposure, and during reintroduction treatment. J Clin Psychiatry. 2008;69(2):222–232. doi: 10.4088/JCP.v69n0208.
    1. Zis P, Shafique F, Hadjivassiliou M, Blackburn D, Venneri A, Iliodromiti S, et al. Safety, tolerability, and nocebo phenomena during transcranial magnetic stimulation: a systematic review and meta-analysis of placebo-controlled clinical trials. Neuromodulation. 2020;23(3):291–300. doi: 10.1111/ner.12946.
    1. Charlotte CT, Ziad N, Andrew MS, Monica M, Laurie ES, Kenneth MS, et al. Changes in prefrontal cortex and paralimbic activity in depression following two weeks of daily left prefrontal TMS. J Neuropsychiatry Clin Neurosci. 1999;11(4):426–435.
    1. Fierro B, De Tommaso M, Giglia F, Giglia G, Palermo A, Brighina F. Repetitive transcranial magnetic stimulation (rTMS) of the dorsolateral prefrontal cortex (DLPFC) during capsaicin-induced pain: modulatory effects on motor cortex excitability. Exp Brain Res. 2010;203(1):31–38. doi: 10.1007/s00221-010-2206-6.

Source: PubMed

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