Evidence map›Paper›PMID 35922816›Full record

ArticleTrials2022

Safety of low-intensity repetitive transcranial magneTic brAin stimUlation foR people living with mUltiple Sclerosis (TAURUS): study protocol for a randomised controlled trial.

Kalina Makowiecki, Natasha Stevens, Carlie L Cullen, Amin Zarghami, Phuong Tram Nguyen, Lewis Johnson, Jennifer Rodger, Mark R Hinder, Michael Barnett, Kaylene M Young and 1 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.0field-weighted citation impact, top 24% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 14 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 3 institutions in 1 country.

Kalina MakowieckiMenzies Institute for Medical Research, University of Tasmania, Hobart, TAS, Australia. kalina.makowiecki@utas.edu.au.ORCID http://orcid.org/0000-0003-4550-3819
Natasha StevensMenzies Institute for Medical Research, University of Tasmania, Hobart, TAS, Australia.
Carlie L CullenMenzies Institute for Medical Research, University of Tasmania, Hobart, TAS, Australia.
Amin ZarghamiMenzies Institute for Medical Research, University of Tasmania, Hobart, TAS, Australia.
Phuong Tram NguyenMenzies Institute for Medical Research, University of Tasmania, Hobart, TAS, Australia.
Lewis JohnsonMenzies Institute for Medical Research, University of Tasmania, Hobart, TAS, Australia.
Jennifer RodgerSchool of Biological Sciences, The University of Western Australia, Crawley, WA, Australia.
Mark R HinderSensorimotor Neuroscience and Ageing Research Lab, School of Psychological Sciences, University of Tasmania, Hobart, TAS, Australia.
Michael BarnettSydney Neuroimaging Analysis Centre (SNAC), Sydney, NSW, Australia.
Kaylene M Young *Menzies Institute for Medical Research, University of Tasmania, Hobart, TAS, Australia.
Bruce V Taylor *Menzies Institute for Medical Research, University of Tasmania, Hobart, TAS, Australia.
University of Tasmania · AUThe University of Sydney · AUThe University of Western Australia · AU

Funding

Royal Hobart Hospital Research Foundation C0026309
6 · The paper itself

Abstract

backgroundMultiple 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.

methodsParticipants (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.

trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12619001196134 . Registered on 27 August 2019.

Indexed as

Multiple SclerosisTranscranial Magnetic StimulationAdolescentAdultAgedAustraliaBrainHumansMiddle AgedQuality of LifeRandomized Controlled Trials as TopicTreatment OutcomeYoung AdultAnxietyBrain stimulationDepressioniTBSMRIMultiple sclerosisMyelinRemyelinationRepetitive transcranial magnetic stimulationrTMSSafety

Identifiers

PMID35922816
PMCPMC9347125
OpenAlexW4289517567

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.