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).
Tolerability
Transcranial Doppler
DOI:
10.21203/rs.2.23373/v1
Publication Date:
2020-02-12T19:30:18Z
AUTHORS (16)
ABSTRACT
Abstract Background This is a phase II randomised, double-blind, placebo-controlled trial to evaluate the effectiveness and tolerability of repetitive transcranial magnetic stimulation for preventive treatment episodic migraine among subjects. Methods Subjects age 18 60 years will undergo baseline evaluation ascertain diagnosis based on International Classification Headache Disorder 3 rd Edition (ICHD-3). Only those who fulfil ICHD-3 criteria compliant headache diary during month run-in period be enrolled. A total 76 subjects randomised receive either or placebo 5 sessions within 2 weeks duration. Follow up conducted monthly three consecutive months. Prior treatment, required fill questionnaires few procedures such as electroencephalography, doppler ultrasound biochemical analysis serum serotonin, calcitonin-gene related peptide beta-endorphin. These repeated post-treatment their last visit. The primary outcome measure this study difference in mean days at 1, after sessions. Discussion Following evidence from previous studies showing restoration dorsolateral prefrontal cortex (DLPFC) activation near normal level, rTMS intervention target left DLPFC study. Meanwhile, terms frequency, least number reported which proved effective treating was session given alternate days. Hence, study, an intermediate duration selected. It set five
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