Evidence map›Paper›PMID 39245707›Full record

ArticleTrials2024

A phase II trial examining the safety and preliminary efficacy of repetitive transcranial magnetic stimulation (rTMS) for people living with multiple sclerosis.

Natasha Stevens, Chigozie Ezegbe, Valery Fuh-Ngwa, Kalina Makowiecki, Amin Zarghami, Phuong Tram Nguyen, Julie Sansom, Kate Smith, Laura L Laslett, Meg Denham and 6 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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

2 citing papers in PubMed.

  1. Review
  2. Article
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

16 authors.

Natasha Stevens *Menzies Institute for Medical Research, University of Tasmania, Hobart, TAS, Australia. natasha.stevens@utas.edu.au.ORCID http://orcid.org/0000-0002-3910-7863
Chigozie Ezegbe *Menzies Institute for Medical Research, University of Tasmania, Hobart, TAS, Australia.
Valery Fuh-NgwaMenzies Institute for Medical Research, University of Tasmania, Hobart, TAS, Australia.
Kalina MakowieckiMenzies 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.
Julie SansomMenzies Institute for Medical Research, University of Tasmania, Hobart, TAS, Australia.
Kate SmithMenzies Institute for Medical Research, University of Tasmania, Hobart, TAS, Australia.
Laura L LaslettMenzies Institute for Medical Research, University of Tasmania, Hobart, TAS, Australia.
Meg DenhamMenzies Institute for Medical Research, University of Tasmania, Hobart, TAS, Australia.
Carlie L CullenMenzies Institute for Medical Research, University of Tasmania, Hobart, TAS, Australia.
Michael H BarnettSydney Neuroimaging Analysis Centre (SNAC), Sydney, NSW, Australia.
Mark R HinderSensorimotor Neuroscience and Ageing Research Lab, School of Psychological Sciences, University of Tasmania, Hobart, Australia.
Monique BreslinMenzies Institute for Medical Research, University of Tasmania, Hobart, TAS, 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.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMultiple sclerosis (MS) is a chronic neurological condition and the leading cause of non-traumatic disability in young adults. MS pathogenesis leads to the death of oligodendrocytes, demyelination, and progressive central nervous system neurodegeneration. Endogenous remyelination occurs in people with MS (PwMS) but is insufficient to repair the damage. Our preclinical studies in mice indicate that endogenous remyelination can be supported by the delivery of repetitive transcranial magnetic stimulation (rTMS). Our phase I trial concluded that 20 sessions of rTMS, delivered over 5 weeks, are safe and feasible for PwMS. This phase II trial aims to investigate the safety and preliminary efficacy of rTMS for PwMS.

methodsParticipants must be aged 18-65 years, diagnosed with MS by a neurologist, stable and relapse free for 6 months, have an Extended Disability Status Scale (EDSS) between 1.5 and 6 (inclusive), willing to travel to a study site every weekday for 4 consecutive weeks, and able to provide informed consent and access the internet. Participants from multiple centres will be randomised 2:1 (rTMS to sham) stratified by sex. The intervention will be delivered with a Magstim Rapid2 stimulator device and circular 90-mm coil or MagVenture MagPro stimulator device with C100 circular coil, positioned to stimulate a broad area including frontal and parietal cortices. For the rTMS group, pulse intensity will be set at 18% (MagVenture) or 25% (Magstim) of maximum stimulator output (MSO), and rTMS applied as intermittent theta burst stimulation (iTBS) (~ 3 min per side; 600 pulses). For the sham group, the procedure will be the same, but the intensity is set at 0%. Each participant will attend 20 intervention sessions over a maximum of 5 weeks. Outcome measures include MS Functional Composite Score (primary), Fatigue Severity Scale, Hospital Anxiety and Depression Scale, Quality of Life, and Pittsburgh Sleep Quality Index/Numeric Rating Scale and adverse events (secondary) and advanced MRI metrics (tertiary). Outcomes will be measured at baseline and after completing the intervention. DISCUSSION: This study will determine if rTMS can improve functional outcomes or other MS symptoms and determine whether rTMS has the potential to promote remyelination in PwMS.

trial registrationRegistered with Australian New Zealand Clinical Trials Registry, 20 January 2022; ACTRN12622000064707.

Indexed as

Clinical Trials, Phase II as TopicMultiple SclerosisTranscranial Magnetic StimulationAdolescentAdultAgedDisability EvaluationFemaleHumansMaleMiddle AgedMulticenter Studies as TopicQuality of LifeRandomized Controlled Trials as TopicTime FactorsTreatment OutcomeMRIMultiple sclerosisPROMRemyelinationrTMSTranscranial magnetic stimulation

Identifiers

PMID39245707
PMCPMC11382484

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
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 Socratic graph.