Sternum-worn vibrotactile device in Parkinson's disease: a randomised, double-blind, placebo-controlled pilot trial

Effective, non-invasive treatments for motor and non-motor symptoms in Parkinson's disease (PD) remain limited, and wearable vibrotactile stimulation may help by enhancing sensorimotor integration. This multi-centre, double-blind, pilot randomised controlled trial evaluated the usability, safety and tolerability of the CUE1+ sternum-worn vibrotactile device, with exploratory clinical outcomes compared with a sham device. Fifty adults with idiopathic PD, stable on antiparkinsonian medication, were randomised to active CUE1+ (n = 25) or sham (n = 25) for 12-weeks (8 h/day), with ON-medication assessments at baseline and week-13. Four participants (8%) discontinued; compliance exceeded 95% in both groups, and 2 (4.2%) experienced mild, transient skin irritation. Exploratory between-group differences favoured active stimulation on MDS-UPDRS Part III (-11.1 points; 95%CI -17.3 to -4.9) and the PDQ-39 Summary Index (-7.6 points; 95%CI -12.3 to -3.0). CUE1+ was usable, safe, and well tolerated. The exploratory clinical signals do not establish efficacy and require confirmation in adequately powered trials using an active vibrotactile sham. Trial registration: ClinicalTrials.gov, NCT06174948. Registered 13 February 2024.