OBJECTIVES:

This analysis evaluated real-world efficacy of Transcutaneous Afferent Patterned Stimulation (TAPS) therapy for symptomatic tremor relief in essential tremor (ET) patients. TAPS is a non-invasive neuromodulation therapy delivering peripheral electrical stimulation tuned to each patient’s tremor physiology. TAPS has been shown to be a safe and effective symptomatic therapy in single-session and longitudinal home-use clinical trials

METHODS:

This analysis evaluated de-identified data from patients using a wrist-worn TAPS device (Cala Health, Burlingame, CA, USA) for at least 30 days. An accelerometer on the device captured tremor severity prior to and immediately following the patient’s therapeutic sessions. Therapy efficacy for each patient was quantified using (i) median improvement in tremor power for that patient’s 25% most severe sessions, (ii) median improvement in device-measured tremor power over all available sessions, and (iii) patient-reported improvements in activities of daily living and quality of life as measured by an opt-in post-market survey.

RESULTS:

178 patients met the 30-day inclusion criteria and had at least 10 sessions with accelerometer recordings. Objective tremor severity measurements from 8,828 therapy sessions showed that 90% of patients had a ≥2-fold reduction in tremor power during their most severe sessions (i.e., when therapeutic relief was most needed) and 57% of patients had ≥2-fold reduction in tremor power aggregated over all sessions. 48 of 178 patients responded to the survey. Patients overwhelmingly (92%) reported activities of daily living as the area of most important therapeutic need, with 69% reporting improvement in at least one of eating/drinking/writing and 48% reporting improvement in overall quality of life.

CONCLUSIONS:

The observed tremor relief with home-use of TAPS therapy was reproduced across objective and patient-rated metrics and is consistent with previous clinical trial findings on efficacy of TAPS. These findings suggest TAPS therapy may be a valuable option for ET patients seeking non-invasive, non-pharmacological symptomatic treatment.