A pilot interventional study on feasibility and effectiveness of the CUE1 device in Parkinson's disease.

Background: 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. This study aimed 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), and Functional Gait Assessment (FGA). Patients-reported outcomes were assessed through MDS-UPDRS Part-I, Part-II, and Part-IV.

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 Part-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), MDS-UPDRS Part-I (18.60 ± 6.75 vs 12.20 ± 3.68, p = 0.011), MDS-UPDRS Part-II (17.30 ± 7.29 vs 11.90 ± 8.67, p = 0.002), and MDS-UPDRS Part-IV(7.50 ± 3.75 vs 3.40 ± 2.95, p = 0.003).

Conclusions: In this unblinded, feasibility study, cueing with vibrotactile stimulation delivered via the CUE1 technology appeared to be a feasible, safe and well tolerated intervention for PwP improving motor and non-motor features.