Evidence map›Paper›PMID 41068419›Full record

Trial reportJournal of neurology2025

Feasibility, safety and efficacy of multi-dose vagus nerve stimulation in Parkinson's disease: a double-blind, randomised sham-controlled proof-of-concept study.

Hilmar P Sigurdsson, Heather Hunter, Lisa Alcock, Evangeline E Maughan, Harvey Bramley, Philip Brown, Giovanni Palermo, Mark R Baker, John-Paul Taylor, Lynn Rochester and 1 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of neurology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–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 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
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.

Hilmar P SigurdssonTranslational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK.ORCID http://orcid.org/0000-0002-0624-065X
Heather HunterThe Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.ORCID http://orcid.org/0000-0003-1187-0936
Lisa AlcockTranslational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK.ORCID http://orcid.org/0000-0002-8364-9803
Evangeline E MaughanTranslational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK.
Harvey BramleyTranslational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK.
Philip BrownThe Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.
Giovanni PalermoTranslational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK.ORCID http://orcid.org/0000-0002-9193-3150
Mark R BakerTranslational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK.ORCID http://orcid.org/0000-0001-6916-1329
John-Paul TaylorTranslational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK.ORCID http://orcid.org/0000-0001-7958-6558
Lynn RochesterTranslational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK.ORCID http://orcid.org/0000-0001-5774-9272
Alison J YarnallTranslational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK. alison.yarnall@newcastle.ac.uk.ORCID http://orcid.org/0000-0002-3126-9163

Funding

Dunhill Medical Trust RPGF/154Parkinson's UK G-1903
6 · The paper itself

Abstract

backgroundGait and cognitive impairments are hallmark features of Parkinson's disease (PD) that significantly impact quality of life. These deficits arise from both dopaminergic and non-dopaminergic mechanisms, including cholinergic dysfunction. Transcutaneous cervical vagus nerve stimulation (tcVNS) is a non-invasive neuromodulatory technique that may enhance cholinergic function and has potential therapeutic relevance for individuals with PD. However, its feasibility, acceptability, adherence, and safety in a domiciliary setting remain unclear. We conducted a single-centre, double-blind, parallel, sham-controlled, randomised proof-of-concept study.

objectivesThe primary objective was to assess the feasibility, acceptability, adherence, and safety of home-based tcVNS. The secondary objective was to explore preliminary effects on gait and cognitive function.

methodsThirty-three participants with PD were randomised to either active (n = 16) or sham (n = 17) tcVNS and self-administered two stimulations twice daily for 12 weeks, followed by a 24-week post-intervention follow-up.

resultsRetention was high (93.9%), with two participants withdrawing from the sham group for reasons unrelated to the intervention. No serious adverse events were reported during the intervention period. Mild adverse events led to discontinuation of tcVNS use in three active and two sham participants. tcVNS had minimal effects on gait and cognition, although small, non-significant improvements in step length variability were observed.

conclusionsThis study represents the longest tcVNS intervention trial in PD to date and supports the feasibility, acceptability, and safety of domiciliary tcVNS. While preliminary findings suggest tcVNS may have therapeutic potential, larger trials are needed to establish its effectiveness for improving gait and cognitive function in PD.

Indexed as

Parkinson DiseaseVagus Nerve StimulationAgedDouble-Blind MethodFeasibility StudiesFemaleGait Disorders, NeurologicHumansMaleMiddle AgedProof of Concept StudyTreatment OutcomeAttentionFeasibilityGaitParkinson’s diseaseRandomised controlled trialVagus nerve stimulation

Identifiers

PMID41068419
PMCPMC12511173

What OpenQuestion holds

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Registered trials

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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.