A Pilot Interventional Study on Feasibility and Effectiveness of the CUE1 device in Parkinson’s disease

SCIENTIFIC ABSTRACT 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. PLAIN ABSTRACT Background and Objectives This study looked at the use of a device called CUE1, which provides rhythmic pulsing vibration to help reduce movement and non-movement symptoms in people with Parkinson’s disease (PwP). Even with current treatments, issues with walking and falling still affect the quality of life for many patients. The goal of this study was to see if CUE1 could be a helpful, safe, and easy-to-use tool for improving movement symptoms, like walking and risk of falling, as well as non-movement symptoms, like sleep. Procedures and Results Ten people with Parkinson’s (5 women, aged 46-80) who had Parkinson’s for 3-9 years used the CUE1 device for 9 weeks. Everyone finished the study, using the device regularly with no negative side effects. The device was rated 80% for comfort and ease of use. Significant improvements were seen in movement abilities (using the MDS-UPDRS-III test), walking speed, and fall risk. Over the 9 weeks, participants showed further progress in movement, balance, and coordination. Non-movement symptoms, like sleep, also improved. Conclusions The CUE1 device, which provides gentle vibrations to assist with movement, was found to be safe, easy to use, and effective. It improved both movement-related symptoms like balance and walking, as well as non-movement symptoms like sleep. This makes it a promising new treatment option for people with Parkinson’s.