Abstract
Abstract
Background
Essential tremor (ET) impacts daily activities and quality of life. A pivotal study of a transcutaneous peripheral nerve stimulation (TPNS) device, the Felix NeuroAI Wristband, led to Food and Drug Administration (FDA) clearance in 2025.
Objective
The aim of the study was to report 1‐year follow‐up results.
Methods
Patients who completed the 90‐day randomized phase could continue until 1 year after the baseline visit; those in the sham group were crossed over to active TPNS treatment (delayed‐start TPNS). Outcome measures were assessed at 180 days and 1 year: modified Activities of Daily Living (mADL) subscale of TETRAS, Clinical and Patient Global Impression of Improvement (CGI‐I and PGI‐I), Quality of Life in Essential Tremor Questionnaire, and adverse device effects (ADEs).
Results
Of 93 patients who entered the extension phase (58 TPNS and 35 delayed start), 57 (38 and 19, respectively) completed 1 year of follow‐up. In the TPNS group, mADL improvement increased from 6.9 points at day 90 to 9.7 points at 1 year. Ninety days of active treatment improved mADL scores by 5.5 points in the delayed‐start TPNS group (day 180). From baseline, TETRAS ADL scores in the TPNS group improved by 6.1 ± 6.0 points at 90 days and 9.3 ± 6.0 points at 1 year. CGI‐I, PGI‐I, and quality of life improved in both groups from 90 days to 1 year. Twenty‐three new ADEs occurred (mild skin irritation, n = 22; muscle spasms, n = 1).
Conclusions
TPNS use was associated with sustained functional improvement for up to 1 year with acceptable safety. Patients who initiated active therapy earlier demonstrated greater cumulative benefit.