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)

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

High-frequency repetitive transcranial magnetic stimulation at dorsolateral prefrontal cortex for migraine prevention: A protocol for a systematic review of controlled trials

“…To our knowledge, there is still no systematic review of hf-rTMS at DLPFC for migraine to date. Thus, its effectiveness for migraine prevention needs to be investigated [ 11 , 21 ].…”

Possibilities of Using Transcranial Magnetic Stimulation for Migraine

“…В систематическом обзоре ученых Safiai N.I.M., Mohamad N.A., Basri H., опубликованном в 2021 г., проведена оценка эффективности, безопасности и переносимости высокочастотной рТМС, применяемой для профилактики мигрени [34]. На основании рандомизированного двойного слепого контролируемого исследования разработан протокол (стимуляция левой ДЛПФК в течение 5-ти сеансов) применения рТМС для профилактического лечения эпизодической головной боли при мигрени с аурой [35].…”

“…Еще одним важным фактором является цель стимуляции. По данным некоторых исследований, ТМС кажется более эффективной при применении над М1, чем над ДЛПФК [39], в других исследованиях наоборот [40].…”

Transcranial Magnetic Stimulation as a Therapy for Migraine: An Overview of Systematic Reviews

“…8,9 In recent years, neuroregulation devices, such as transcranial magnetic stimulation (TMS) has gained wide recognition as an option for treating migraines. [10][11][12] In order to suppress or alleviate migraine symptoms, TMS has been developed to target CSD through disrupting the propagation of electrical activity during migraine attacks via magnetic field stimulation of specific areas of the brain. 13 Considering its role in inhibiting CSD, there is growing interest in using TMS to treat migraines.…”