Evidence map›Paper›PMID 40288787›Full record

ArticleBMJ open2025

Non-invasive device to alleviate symptoms in people living with Parkinson's: study protocol for a multicentre phase II double-blind randomised controlled trial.

Viktoria Azoidou, Essa Bhadra, Kira Rowsell, Ellen Camboe, Kamalesh Dey, Alexandra Zirra, Corrine Quah, Caroline Budu, Thomas Boyle, David Gallagher and 2 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
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. It is linked to trial NCT06174948 (The Use of the CUE1/CUE1+ Device in People With Idiopathic Parkinson's Disease and Related Disorders), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

NCT06174948 narecruitingnot on this map

The Use of the CUE1/CUE1+ Device in People With Idiopathic Parkinson's Disease and Related Disorders: A Feasibility Study

TypeinterventionalSponsorQueen Mary University of LondonRan2024 to 2025Enrolled70ConditionsParkinson's Disease and Parkinsonism, Progressive Supranuclear Palsy, Different Types of Tremor Including Essential Tremor, DystoniaArmsCUE1 non-invasive device, CUE1+ device active vs sham CUE1+ device
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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

12 authors.

Viktoria AzoidouWolfson Institute of Population Health, Queen Mary University of London, London, UK v.azoidou@qmul.ac.uk.ORCID http://orcid.org/0009-0003-3613-4764
Essa BhadraDepartment of Neurology, Barts Health NHS Trust, London, UK.
Kira RowsellDepartment of Neurology, Homerton Healthcare NHS Foundation Trust, London, UK.
Ellen CamboeWolfson Institute of Population Health, Queen Mary University of London, London, UK.
Kamalesh DeyWolfson Institute of Population Health, Queen Mary University of London, London, UK.
Alexandra ZirraWolfson Institute of Population Health, Queen Mary University of London, London, UK.
Corrine QuahDepartment of Neurology, Homerton Healthcare NHS Foundation Trust, London, UK.
Caroline BuduDepartment of Neurology, Barts Health NHS Trust, London, UK.
Thomas BoyleOlder Person's Services & GIM Special Interest in Parkinson's Disease, Barts Health NHS Trust, London, UK.
David GallagherDepartment of Neurology, Barts Health NHS Trust, London, UK.
Alastair NoycePreventive Neurology Unit, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.
Cristina SimonetWolfson Institute of Population Health, Queen Mary University of London, London, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionExisting interventions for people with Parkinson's disease (PwP) often fall short in addressing gait disturbances and falls, impacting their quality of life. The CUE1 non-invasive medical device, along with its updated version, CUE1+, offers vibrotactile stimulation with cueing. The device shows promise in alleviating motor symptoms and reducing falls based on early user testing and a 9-week pilot study. This study aims to assess the usability, safety, tolerability and effectiveness of CUE1+ in improving Parkinson's symptoms compared with a sham device over a 12-week period. METHODS AND ANALYSIS: This multicentre, phase II double-blind randomised controlled trial will recruit 50 PwP from Barts Health and Homerton NHS Hospitals, enrolling them at Queen Mary University of London. Participants, diagnosed with idiopathic Parkinson's, aged 18+ and providing written consent, will be randomly assigned to either the experimental group (CUE1+ device) or control group (sham device). The primary outcome is the device usability over 12 weeks. Measures include the recruitment, compliance and dropout rates, and safety/tolerability which will be collected through a participant clinical diary at baseline (week 0) and follow-up (week 13). Effectiveness will be evaluated at the same time points using movement tests (MDS-UPDRS Part III, Functional Gait Assessment, Timed Up and Go in isolation and with dual tasking and two keyboard-based typing tests-Bradykinesia Akinesia Incoordination and Digital Finger Tapping), with video recordings. Participants will wear a Parkinson's KinetiGraph wristband to monitor symptoms at home continuously for 12 weeks and collect real-world data. Patient-reported outcomes will be collected at baseline and follow-up and include MDS-UPDRS Part I, II and IV, Activity-specific Balance Scale, Pittsburgh Sleep Quality Index, Hospital Anxiety and Depression Scale, Fatigue Symptom Scale and Parkinson's Disease Questionnaire-39. ETHICS AND DISSEMINATION: The study has received ethical approval from London-Dulwich Research Ethics Committee (reference: 23/PR/1526). Findings will be submitted for peer-reviewed publications. TRIAL REGISTRATION NUMBER: NCT06174948.

Indexed as

Parkinson DiseaseVibrationAccidental FallsAgedClinical Trials, Phase II as TopicDouble-Blind MethodFemaleHumansMaleMiddle AgedMulticenter Studies as TopicQuality of LifeRandomized Controlled Trials as TopicGaitParkinson-s diseaseProtocols & guidelinesRandomized Controlled TrialWearable Electronic Devices

Identifiers

PMID40288787
PMCPMC12035462

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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.