Azoidou Viktoria, Bhadra Essa, Rowsell Kira, Camboe Ellen, Dey Kamalesh, Zirra Alexandra, Quah Corrine, Budu Caroline, Boyle Thomas, Gallagher David, Noyce Alastair, Simonet Cristina
Wolfson Institute of Population Health, Queen Mary University of London, London, UK
Department of Neurology, Barts Health NHS Trust, London, UK.
BMJ Open. 2025 Apr 27;15(4):e096051. doi: 10.1136/bmjopen-2024-096051.
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.
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.
The study has received ethical approval from London-Dulwich Research Ethics Committee (reference: 23/PR/1526). Findings will be submitted for peer-reviewed publications.
NCT06174948.
现有的针对帕金森病患者（PwP）的干预措施在解决步态障碍和跌倒问题方面往往存在不足，影响了他们的生活质量。CUE1非侵入性医疗设备及其升级版CUE1+可提供带提示的振动触觉刺激。基于早期用户测试和为期9周的试点研究，该设备在缓解运动症状和减少跌倒方面显示出前景。本研究旨在评估在12周的时间里，与假设备相比，CUE1+在改善帕金森症状方面的可用性、安全性、耐受性和有效性。
这项多中心、II期双盲随机对照试验将从巴茨健康医院和霍默顿国民保健服务医院招募50名帕金森病患者，在伦敦玛丽女王大学进行入组。年龄在18岁及以上、被诊断为特发性帕金森病且提供书面同意书的参与者将被随机分配到实验组（CUE1+设备）或对照组（假设备）。主要结局是12周内的设备可用性。测量指标包括招募率、依从率和退出率，以及安全性/耐受性，这些将通过参与者在基线（第0周）和随访（第13周）时的临床日记收集。有效性将在相同时间点使用运动测试（MDS-UPDRS第三部分、功能性步态评估、单任务和双任务定时起立行走测试以及两项基于键盘的打字测试——运动迟缓、运动不能、不协调和数字手指敲击测试）并进行视频记录来评估。参与者将佩戴帕金森病运动监测仪腕带，在家中连续监测症状12周并收集真实世界数据。患者报告的结局将在基线和随访时收集，包括MDS-UPDRS第一、二和四部分、特定活动平衡量表、匹兹堡睡眠质量指数、医院焦虑抑郁量表、疲劳症状量表和帕金森病问卷-39。
该研究已获得伦敦-达利奇研究伦理委员会的伦理批准（参考编号：23/PR/1526）。研究结果将提交至同行评审期刊发表。
NCT06174948。
