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 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.