Non-invasive device to alleviate symptoms in people living with Parkinson’s: study protocol for a multicentre phase II double-blind randomised controlled trial
Introduction Existing 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 dev...
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BMJ Publishing Group
2025-04-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/15/4/e096051.full |
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| author | David Gallagher Cristina Simonet Alexandra Zirra Alastair Noyce Caroline Budu Ellen Camboe Viktoria Azoidou Essa Bhadra Kira Rowsell Kamalesh Dey Corrine Quah Thomas Boyle |
| author_facet | David Gallagher Cristina Simonet Alexandra Zirra Alastair Noyce Caroline Budu Ellen Camboe Viktoria Azoidou Essa Bhadra Kira Rowsell Kamalesh Dey Corrine Quah Thomas Boyle |
| author_sort | David Gallagher |
| collection | DOAJ |
| description | Introduction Existing 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. |
| format | Article |
| id | doaj-art-0b7775fa62344311814ab20feb51cfd6 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-0b7775fa62344311814ab20feb51cfd62025-08-20T03:52:32ZengBMJ Publishing GroupBMJ Open2044-60552025-04-0115410.1136/bmjopen-2024-096051Non-invasive device to alleviate symptoms in people living with Parkinson’s: study protocol for a multicentre phase II double-blind randomised controlled trialDavid Gallagher0Cristina Simonet1Alexandra Zirra2Alastair Noyce3Caroline Budu4Ellen Camboe5Viktoria Azoidou6Essa Bhadra7Kira Rowsell8Kamalesh Dey9Corrine Quah10Thomas Boyle11Infectious Diseases, Galway University Hospitals, Galway, Ireland1 Preventive Neurology Unit, Wolfson Institute of Preventive Medicine, London, UK1The National Hospital for Neurology and NeurosurgeryCentre of Preventive Neurology, Wolfson Institute of Population Health, Queen Mary University of London, London, UK2Royal London Hospital, Bart’s Health NHS Trust, London3Centre for Preventive Neurology, Wolfson Institute of Population Health, Queen Mary University of London, London, UKWolfson Institute of Population Health, Queen Mary University of London, London, UKDepartment of Neurology, Barts Health NHS Trust, London, UKDepartment of Neurology, Homerton Healthcare NHS Foundation Trust, London, UKWolfson Institute of Population Health, Queen Mary University of London, London, UKDepartment of Neurology, Homerton Healthcare NHS Foundation Trust, London, UKOlder Person`s Services & GIM Special Interest in Parkinson’s Disease, Barts Health NHS Trust, London, UKIntroduction Existing 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.https://bmjopen.bmj.com/content/15/4/e096051.full |
| spellingShingle | David Gallagher Cristina Simonet Alexandra Zirra Alastair Noyce Caroline Budu Ellen Camboe Viktoria Azoidou Essa Bhadra Kira Rowsell Kamalesh Dey Corrine Quah Thomas Boyle Non-invasive device to alleviate symptoms in people living with Parkinson’s: study protocol for a multicentre phase II double-blind randomised controlled trial BMJ Open |
| title | Non-invasive device to alleviate symptoms in people living with Parkinson’s: study protocol for a multicentre phase II double-blind randomised controlled trial |
| title_full | Non-invasive device to alleviate symptoms in people living with Parkinson’s: study protocol for a multicentre phase II double-blind randomised controlled trial |
| title_fullStr | Non-invasive device to alleviate symptoms in people living with Parkinson’s: study protocol for a multicentre phase II double-blind randomised controlled trial |
| title_full_unstemmed | Non-invasive device to alleviate symptoms in people living with Parkinson’s: study protocol for a multicentre phase II double-blind randomised controlled trial |
| title_short | Non-invasive device to alleviate symptoms in people living with Parkinson’s: study protocol for a multicentre phase II double-blind randomised controlled trial |
| title_sort | non invasive device to alleviate symptoms in people living with parkinson s study protocol for a multicentre phase ii double blind randomised controlled trial |
| url | https://bmjopen.bmj.com/content/15/4/e096051.full |
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