Makowiecki, K and Stevens, N and Cullen, CL and Zarghami, A and Nguyen, PT and Johnson, L and Rodger, J and Hinder, MR and Barnett, M and Young, KM and Taylor, BV, Safety of low-intensity repetitive transcranial magneTic brAin stimUlation foR people living with mUltiple Sclerosis (TAURUS): study protocol for a randomised controlled trial, Trials, 23, (1) pp. 1-18. ISSN 1745-6215 (2022) [Refereed Article]
Background: Multiple sclerosis (MS) is an inflammatory and neurodegenerative disease, characterised by oligodendrocyte death and demyelination. Oligodendrocyte progenitor cells can differentiate into new replacement oligodendrocytes; however, remyelination is insufficient to protect neurons from degeneration in people with MS. We previously reported that 4 weeks of daily low-intensity repetitive transcranial magnetic stimulation (rTMS) in an intermittent theta-burst stimulation (iTBS) pattern increased the number of new myelinating oligodendrocytes in healthy adult mice. This study translates this rTMS protocol and aims to determine its safety and tolerability for people living with MS. We will also perform magnetic resonance imaging (MRI) and symptom assessments as preliminary indicators of myelin addition following rTMS.
Methods: Participants (N = 30, aged 18-65 years) will have a diagnosis of relapsing-remitting or secondary progressive MS. ≤2 weeks before the intervention, eligible, consenting participants will complete a physical exam, baseline brain MRI scan and participant-reported MS symptom assessments [questionnaires: Fatigue Severity Scale, Quality of Life (AQoL-8D), Hospital Anxiety and Depression Scale; and smartphone-based measures of cognition (electronic symbol digit modalities test), manual dexterity (pinching test, draw a shape test) and gait (U-Turn test)]. Participants will be pseudo-randomly allocated to rTMS (n=20) or sham (placebo; n=10), stratified by sex. rTMS or sham will be delivered 5 days per week for 4 consecutive weeks (20 sessions, 6 min per day). rTMS will be applied using a 90-mm circular coil at low-intensity (25% maximum stimulator output) in an iTBS pattern. For sham, the coil will be oriented 90° to the scalp, preventing the magnetic field from stimulating the brain. Adverse events will be recorded daily. We will evaluate participant blinding after the first, 10th and final session. After the final session, participants will repeat symptom assessments and brain MRI, for comparison with baseline. Participant-reported assessments will be repeated at 4-month post-allocation follow-up.
Discussion: This study will determine whether this rTMS protocol is safe and tolerable for people with MS. MRI and participant-reported symptom assessments will serve as preliminary indications of rTMS efficacy for myelin addition to inform further studies.
|Item Type:||Refereed Article|
|Keywords:||multiple sclerosis; transcranial magnetic stimulation; myelin; safety|
|Research Division:||Biomedical and Clinical Sciences|
|Research Field:||Cellular nervous system|
|Objective Division:||Expanding Knowledge|
|Objective Group:||Expanding knowledge|
|Objective Field:||Expanding knowledge in the biomedical and clinical sciences|
|UTAS Author:||Makowiecki, K (Dr Kalina Makowiecki)|
|UTAS Author:||Stevens, N (Ms Natasha Stevens)|
|UTAS Author:||Cullen, CL (Dr Carlie Cullen)|
|UTAS Author:||Zarghami, A (Mr Amin Zarghami)|
|UTAS Author:||Nguyen, PT (Ms Phuong Tram Nguyen)|
|UTAS Author:||Johnson, L (Mr Lewis Johnson)|
|UTAS Author:||Hinder, MR (Associate Professor Mark Hinder)|
|UTAS Author:||Young, KM (Professor Kaylene Young)|
|UTAS Author:||Taylor, BV (Professor Bruce Taylor)|
|Deposited By:||Menzies Institute for Medical Research|
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