Low-intensity repetitive transcranial magnetic stimulation is safe and well tolerated by people living with MS - outcomes of the phase I randomised controlled trial (TAURUS)

Background Low-intensity repetitive transcranial magnetic stimulation (rTMS), delivered as a daily intermittent theta burst stimulation (iTBS) for 4 consecutive weeks, increases the number of new oligodendrocytes in the adult mouse brain. rTMS holds potential as a remyelinating intervention for people with MS. Objective Primarily to determine the safety and tolerability of our rTMS protocol in people with MS. Secondary objectives included feasibility, blinding, and an exploration of changes in magnetic resonance imaging (MRI) metrics, patient reported outcome measures (PROMs) and cognitive or motor performance. Methods A randomised (2:1), placebo controlled, single blind, parallel group, phase 1 trial of 20 rTMS sessions (600 iTBS pulses per hemisphere; 25% maximum stimulator output), delivered over 4-5 weeks, with the coil positioned at 90° (n=7, ‘sham’) or 0° (n=13, active rTMS). Results Five adverse events (AEs) including one serious AE reported. None were related to treatment. Protocol compliance was high (85%) and blinding successful. Within participant MRI metrics, PROMs and cognitive or motor performance were unchanged over time. Conclusion 20 sessions of rTMS is safe and well tolerated in a small group of people with MS. The study protocol and procedures are feasible. Improvement of sham is warranted before further investigating safety and efficacy. Trial registration Australian New Zealand Clinical Trials Registry (ACTRN12619001196134). https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378010&isReview=true