Objective: This retrospective analysis evaluates the cumulative, sustained effects of a wrist-worn vibratory stimulator over time by examining baseline change over each randomization period, day-over-day composite score changes from Day 1 to Day 5, and benefits beyond the therapy week.

Background: Essential Tremor (ET) is a chronic condition with few effective therapies. The investigational vibrotactile stimulator could offer a safe, non-invasive wrist-worn alternative.

Method: A double-blind, randomized, sham-controlled crossover trial compared active stimulation (Pulsed and Continuous) versus Sham in patients meeting predefined tremor severity thresholds at baseline. Daily performance assessments were completed for 5 days with a 2-day washout before crossover. Improvements in Bain & Findley Activities of Daily Living (BF-ADL) and The Essential Tremor Rating Assessment Scale (TETRAS) were evaluated as both a change in day-over-day (DoD) baseline severity (pre-stimulation trends) and average DoD changes from pre- to intra- stimulation (therapy improvement trends). Therapy residual effects were assessed by analyzing the return of tremors during washout periods.

Results: Of the 47 subjects randomized, 45 were eligible for analysis. Active arms showed a trend of day-over-day pre-stimulation improvement. Pre-stimulation Pulsed trends in BF-ADL were statistically significant compared to a 0-slope trend (t-test, p=0.024) while TETRAS trends although visually observable were not significant [Figure 1]. For BF-ADL, DoD changes continued to improve by >1-point for Pulsed (t-test, p<0.01), sustained 1-point improvement for Continuous, and remained below 1-point for Sham, with TETRAS showing a similar trend up to Day 4 [Figure 2]. Sustained residual effects, reflected by reduced tremor severity during the week following therapy, extended beyond the washout period. Comparisons of DoD pre-stimulation composite scores within and across weeks further supports efficacy extending beyond stimulation periods [Figure 3, Figure 4].

Conclusion: The stimulator delivered sustained therapeutic benefits during and beyond the active treatment week. The distinct response patterns in the Active to Sham and Sham to Active transitions indicate that Active therapy not only outperforms Sham but may also provide lasting benefits, even after up to two days without therapy.

Figure 1

Figure 2

Figure 3

Figure 4

« Back to 2025 International Congress

MDS Abstracts - https://www.mdsabstracts.org/abstract/sustained-benefit-of-a-wrist-worn-vibratory-wearable-on-upper-limb-essential-tremor/