This study evaluated the efficacy and safety of repeated home use of an individualized, non-invasive neuromodulation therapy targeting the median and radial nerves for reducing hand tremor in essential tremor patients over three months.

Single-session studies have shown non-invasive neuromodulation therapy to be safe, well-tolerated, and effective for treatment of ET, but its benefit as a longer-term treatment is unknown.

This was a prospective, multicenter, open-label, single-arm study with 263 patients enrolled across 26 sites. Patients were instructed to use the therapy twice daily for three months. Pre-specified co-primary endpoints were improvements on (1) clinician-rated Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) and (2) patient-rated Bain & Findley Activities of Daily Living (ADL) dominant hand scores. Other endpoints included improvement in the tremor power detected by an accelerometer on the therapeutic device, Clinical and Patient Global Impression scores (CGI-I, PGI-I), and Quality of Life in Essential Tremor (QUEST) survey.

205 patients completed the study. The co-primary endpoints were met (p « 0.0001), with 62% (on TETRAS) and 68% (on ADL) of ‘severe’ or ‘moderate’ patients improving to ‘mild’ or ‘slight’. Similarly, clinicians (CGI-I) reported improvement in 68% of patients, and 60% (PGI-I) of patients reported improvement. QUEST also improved (p = 0.0013). Wrist-worn accelerometer recordings before and after 21,806 therapy sessions showed that 54% of patients experienced ≥ 50% improvement in tremor power. Device-related adverse events (e.g., wrist discomfort, skin irritation, pain) occurred in 18% of patients. No device-related serious adverse events were reported.

This study demonstrated that non-invasive neuromodulation therapy used repeatedly at home over three months results in safe and effective hand tremor reduction in essential tremor patients.  The treatment efficacy and favorable adverse event profile suggest this therapy may be an attractive option for patients who are seeking symptomatic ET treatment with minimal side effects.