Evidence map›Paper›PMID 40139703›Full record

ArticleBMJ open2025

TRanscutaneous lImb reCovEry Post-Stroke (TRICEPS): study protocol for a randomised, controlled, multiarm, multistage adaptive design trial.

Sheharyar S Baig, Cara Mooney, Kirsty McKendrick, Kate E M Duffy, Ali N Ali, Jessica N Redgrave, Esther Herbert, Simon Waterhouse, Li Su, Avril Drummond and 5 more

Abstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2025. 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. Article
  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

15 authors.

Sheharyar S BaigSheffield Institute for Translational Neuroscience, The University of Sheffield, Sheffield, UK.ORCID http://orcid.org/0000-0003-1415-8784
Cara MooneySchool of Medicine and Population Health, The University of Sheffield, Sheffield, UK.ORCID http://orcid.org/0000-0002-3086-7348
Kirsty McKendrickSchool of Medicine and Population Health, The University of Sheffield, Sheffield, UK.
Kate E M DuffySchool of Medicine and Population Health, The University of Sheffield, Sheffield, UK.
Ali N AliSheffield Institute for Translational Neuroscience, The University of Sheffield, Sheffield, UK.
Jessica N RedgraveSheffield Institute for Translational Neuroscience, The University of Sheffield, Sheffield, UK.
Esther HerbertSchool of Medicine and Population Health, The University of Sheffield, Sheffield, UK.
Simon WaterhouseSchool of Medicine and Population Health, The University of Sheffield, Sheffield, UK.
Li SuSheffield Institute for Translational Neuroscience, The University of Sheffield, Sheffield, UK.
Avril DrummondSchool of Health Sciences, University of Nottingham, Nottingham, UK.
Jesse DawsonSchool of Cardiovascular and Metabolic Health, University of Glasgow, Glasgow, UK.
Munyaradzi DimairoSchool of Medicine and Population Health, The University of Sheffield, Sheffield, UK.ORCID http://orcid.org/0000-0002-9311-6920
Katie BiggsSchool of Medicine and Population Health, The University of Sheffield, Sheffield, UK.ORCID http://orcid.org/0000-0003-4468-7417
Cindy CooperSchool of Medicine and Population Health, The University of Sheffield, Sheffield, UK.
Arshad MajidSheffield Institute for Translational Neuroscience, The University of Sheffield, Sheffield, UK arshad.majid@sheffield.ac.uk.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionArm weakness after stroke is one of the leading causes of adult-onset disability. Invasive vagus nerve stimulation (VNS) paired with rehabilitation has been shown to improve arm recovery in chronic stroke. Small studies of non-invasive or transcutaneous VNS (tVNS) suggest it is safe and tolerable. However, it is not known whether tVNS paired with rehabilitation is effective in promoting arm recovery in chronic stroke and what the mechanisms of action are. METHODS AND ANALYSIS: TRICEPS is a UK multicentre, double-blinded, superiority, parallel-group, three-arm two-stage with an option to select promising arm(s) at 50% accrual, individually randomised, sham-controlled trial. Up to 243 participants will be randomised (1:1:1) using minimisation via a restricted, web-based centralised system. tVNS will be delivered by a movement-activated tVNS system (TVNS Technologies), which delivers stimulation during repetitive task practice. Rehabilitation will consist of repetitive task training for 1 hour a day, 5 days per week for 12 weeks. Participants will be adults with anterior circulation ischaemic stroke between 6 months and 10 years prior with moderate-severe arm weakness. The primary outcome measure will be the change in Upper Limb Fugl-Meyer total motor score at 91 days after the start of treatment. Secondary outcome measures include the Wolf Motor Function Test, the Modified Ashworth Scale to assess spasticity in the affected arm and the Stroke-Specific Quality of Life Scale. A mechanistic substudy including 40 participants will explore the mechanisms of active versus sham tVNS using multimodal MRI and serum inflammatory cytokine levels. Participant recruitment started on 30 November 2023. ETHICS AND DISSEMINATION: The study has received ethical approval from the Cambridge Central Research Ethics Committee (REC reference: 22/NI/0134). Dissemination of results will be via publications in scientific journals, meetings, written reports and articles in stakeholder publications. TRIAL REGISTRATION NUMBER: ISRCTN20221867.

Indexed as

ArmStrokeStroke RehabilitationTranscutaneous Electric Nerve StimulationVagus Nerve StimulationAdultDouble-Blind MethodEquivalence Trials as TopicFemaleHumansMaleMulticenter Studies as TopicRandomized Controlled Trials as TopicRecovery of FunctionUnited KingdomClinical trialsRehabilitation medicineStroke

Identifiers

PMID40139703
PMCPMC11950934

What OpenQuestion holds

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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.