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

Health

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.

BMJ     Apr 28, 2025