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<p>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+ (<i>n</i> = 25) or sham (<i>n</i> = 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.</p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年7月3日

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  • Viktoria Azoidou,
  • Essa Bhadra,
  • Ellen Camboe,
  • Kamalesh C. Dey,
  • Alexandra Zirra,
  • Kira Rowsell,
  • Corrine Quah,
  • Caroline Budu,
  • Thomas Boyle,
  • David Gallagher,
  • Jonathan P. Bestwick,
  • Alastair J. Noyce,
  • Cristina Simonet

摘要

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.