Introduction: Current treatments for patients with Parkinson's disease (PwP) can fail to address gait disturbance and falls, which in turn affect quality of life (QoL). The CUE1 device delivers cueing with vibrotactile stimulation showing potential to alleviate motor symptoms and reduce falls based on preliminary user testing results. Objectives: To evaluate the feasibility, safety, and tolerability of CUE1 and its effect on motor and non-motor symptoms in PwP. Methods: PwP used the CUE1 for 9-weeks and were assessed at week 0, 3, 6, and 9 on MDS-UPDRS Part-III, Timed Up and Go (TUG), TUG with dual task (DT), Functional Gait Assessment (FGA), and Bradykinesia Akinesia Incoordination (BRAIN) test. Patients reported outcomes through MDS-UPDRS Part-I, -II, and -IV and Pittsburgh Sleep Quality Index (PSQI). Results: Ten PwP (5 females, age range: 46-80; disease duration: 3-9 years) completed the CUE1 intervention with 100% compliance and no adverse events. CUE1 comfort and usability were rated highly (80%). Immediate CUE1 effect was observed on MDS-UPDRS-III 45.40+/-12.22 vs 39.60+/-11.74, p=0.008), TUG(11.53+/-1.92 vs 11.08+/-1.94, p=0.022), TUG DT(18.57+/-5.75 vs 17.61+/-6.28, p=0.037) and FGA(16.40+/-3.86 vs 18.60+/-3.92, p=0.007). Cumulative effect was noted on MDS-UPDRS-III(45.40+/-12.22 vs 27.80+/-12.32, p=0.005), FGA(18.60+/-3.92 vs 23.10+/-2.85, p<0.001), TUG DT(18.57+/-5.75 vs 13.58+/-7.05, p=0.031), BRAIN kinesia (45.10+/-14.39 vs 42.10+/-12.74, p<0.001) and incoordination (24331.09+/-38017.46 vs 14059.91+/-9030.96, p=0.016) scores, PSQI(10.10+/-4.95 vs 6.90+/-3.81, p=0.002), MDS-UPDRS-I(18.60+/-6.75 vs 12.20+/-3.68, p=0.011), MDS-UPDRS-II(17.30+/-7.29 vs 11.90+/-8.67, p=0.002), and MDS-UPDRS-IV(7.50+/-3.75 vs 3.40+/-2.95, p=0.003). Conclusion: In this unblinded, feasibility study, cueing with the CUE1 appeared to be a feasible and safe intervention for PwP improving motor and non-motor features.

V.A is employed by Queen Mary University of London to work with Charco Neurotech Ltd but she is not employed by Charco Neurotech Ltd. V.A., C.S., and A.J.N. hold a grant (KTP UK 2021 to 2022, round 4, UKRI KTP Innovate UK) to evaluate the effectiveness of the CUE1 device in PwP. A.J.N. is an external advisor to Charco Neurotech Ltd.

NCT06174948

This study is part of the project funded by Knowledge Transfer Partnership (KTP) United Kingdom 2021 to 2022, round 4, UKRI KTP (Innovate UK).

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This study was approved in the UK by the Dulwich Research Ethics Committee (reference number: 23/PR/1526; clinical.trials.gov ID: NCT06174948). The study adhered to the Declaration of Helsinki. All patients provided written informed consent before data collection.

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