Objective: To assess the effect CUE1+ device on motor and non-motor symptoms in people with Parkinson’s (PwP).

Background: Current treatments for PwP often fail to address motor and non-motor symptoms affecting quality of life (QoL)[1]. This pilot double-blind randomized controlled trial aims to validate previous findings, showing that the CUE1 vibrotactile cueing device is safe, well-tolerated, and may improve motor and non-motor symptoms in PwP[2].

Method: Fifty PwP were randomized to receive either active or sham CUE1+ for 12 weeks. Pre- and post-intervention assessments included the motor part (III) of MDS-UPDRS as primary outcome. Secondary outcomes included the Timed Up and Go (TUG), Functional Gait Assessment (FGA), Bradykinesia Akinesia Incoordination (BRAIN) test, MDS-UPDRS Parts I, II, and IV, Pittsburgh Sleep Quality Index (PSQI), and Parkinson’s Disease Questionnaire-39 (PDQ-39). Real-world symptom data was collected continuously for 12 weeks using Parkinson’s KinetiGraph (PKG)[3].

Results: We tested 25 PwP in Group A (60% male, 40% female; age: 43-83; disease duration: 1-22 years) and 25 PwP in Group B (56% male, 44% female; age: 29-86; disease duration: 1-13 years). Pre-intervention, no significant differences were found between Group A and B in motor status (UPDRS-III: 44.57±11.17 vs. 43.40±15.22, p=0.657), manual dexterity (BRAIN test: non-dominant hand: 38.95±14.86 vs. 39.67±9.92, p=0.620; dominant hand: 42.25±8.91 vs. 39.71±13.59, p=0.824), gait measures (TUG: 10.77±3.42 vs. 12.32±7.11, p=0.869; FGA: 16.39±3.12 vs. 16.28±4.59, p=0.561), non-motor symptoms (UPDRS-I: 16.39±8.20 vs. 20.92±9.34, p=0.092; PSQI: 10.33±5.31 vs. 11.90±4.78, p=0.289), and motor symptoms (UPDRS-II: 15.61±8.45 vs. 19.16±10.04, p=0.154; UPDRS-IV: 8.74±5.33 vs. 10.00±4.62, p=0.281). Group B had worse QoL (57.44±26.64 vs. 40.20±26.84, p=0.041). No significant pre-intervention differences were found between groups in PKG measures for bradykinesia (29.88±8.58 vs. 28.24±7.42, p=0.440), fluctuation dyskinesia (8.93±4.53 vs. 8.71±3.12, p=0.851), %Time Immobile (11.14±9.02 vs. 10.40±6.32, p=0.869), and Step Count (5466.00±4535.23 vs. 5810.80±3046.44, p=0.326).

Conclusion: This study is blinded and ongoing. We hypothesise that PwP in the active CUE1+ group will show greater improvements in motor and non-motor symptoms and QoL compared to the sham group. Full results will be presented at the MDS conference in October 2025.

References: [1] Smulders K, Dale ML, Carlson-Kuhta P, Nutt JG, Horak FB. Pharmacological treatment in Parkinson’s disease: Effects on gait. Parkinsonism Relat Disord. 2016;31:3-13. doi:10.1016/j.parkreldis.2016.07.006
[2] Azoidou V, Rowsell K, Camboe E, Dey KC, Zirra A, Quah C, Boyle T, Gallagher D, Noyce AJ, Simonet C. A pilot interventional study on feasibility and effectiveness of the CUE1 device in Parkinson’s disease. Parkinsonism Relat Disord. 2025;133:107349.
[3] Griffiths RI, Kotschet K, Arfon S, et al. Automated assessment of bradykinesia and dyskinesia in Parkinson’s disease. J Parkinsons Dis. 2012;2(1):47-55. doi:10.3233/JPD-2012-11071

« Back to 2025 International Congress

MDS Abstracts - https://www.mdsabstracts.org/abstract/effect-of-cue1-device-on-motor-and-non-motor-symptoms-in-parkinsons-a-pilot-randomised-controlled-trial/