Usability, Safety and Tolerability of CUE1 Vibrotactile Device as Promising Therapeutic Approach in Orthostatic Tremor

Introduction

Primary Orthostatic Tremor (POT) is a rare hyperkinetic movement disorder characterized by unsteadiness while standing, often exacerbated by anxiety and fatigue. It significantly impairs quality of life, and current treatment options are limited, with invasive procedures carrying notable risks.

Methods

This unblinded interventional study assessed the usability, safety, and tolerability of the CUE1, a non-invasive vibrotactile stimulation device worn on the sternum. Secondary exploratory outcomes included objective measures of balance and mobility: maximal stance time, tandem walk, heel raise hold, tandem stance, and Timed Up and Go (TUG) with and without dual tasking (DT). Assessments were performed at baseline, immediately after a 20-minute acclimatization session, and after 9 weeks of daily use (8 hours/day). Patient-reported outcomes on fatigue, anxiety, and perceived change were also collected.

Results

Ten participants with POT (70% female, aged 58-88 years) completed the study. Compliance and tolerability were excellent (100%), with only mild, transient skin irritation reported in two cases. Immediate post-intervention improvements were observed in TUG [-1.22seconds (95% CI: -2.03, -0.26), p=0.020], tandem stance [+1.41seconds (0.00, 6.13), p=0.025], tandem walk [+0.50 steps (0.00, 2.50), p=0.042], and heel raise hold [+1.62seconds (1.00, 3.32), p=0.020]. After 9 weeks, improvements were observed in TUG [-2.13seconds (−4.00, -0.26), p=0.028], TUG-DT [-7.51seconds (−14.88, -0.14), p=0.047], tandem stance [+9.06seconds (1.04, 17.08), p=0.028], fatigue [-7.00 (−13.63, -0.37), p=0.035], and patient-reported impression of change [+1.10 (0.14, 2.06), p=0.027].

Conclusion

CUE1 vibrotactile stimulation is safe, well-tolerated, and shows promise in improving balance, mobility, and fatigue in POT. Larger, controlled trials are warranted.

HIGHLIGHTS

• This pilot interventional study evaluated 9 weeks of daily vibrotactile stimulation using the non-invasive CUE1 device in patients with Primary Orthostatic Tremor (POT).

• All ten participants completed the study with 100% compliance and no serious adverse events; only mild, temporary skin irritation was reported.

• Immediate improvements were seen in balance and mobility measures after a single 20-minute session with the device.

• Continued use over 9 weeks led to significant gains in TUG (with and without dual tasking), tandem stance, and reduced fatigue.

• The CUE1 was safe, well-tolerated, and shows potential as a non-invasive therapeutic option for POT; however, large controlled trials are needed.