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.