Objective: This early post-market analysis evaluated the real-world efficacy of Transcutaneous Afferent Patterned Stimulation (TAPS) therapy used by essential tremor patients over three months of non-supervised home use.

Background: TAPS is a non-invasive neuromodulation therapy targeting the median and radial nerves with a bursting waveform individualized to each patient’s tremor. TAPS has been shown to be a safe and effective symptomatic tremor relief therapy in single-session and extended-duration clinical studies [1-3], but how these results translate from a closely monitored clinical trial into a real-world setting is unknown.

Method: This analysis evaluated de-identified data from patients who were prescribed the wrist-worn TAPS therapeutic device and used the device at home for at least 90 days. Patients were given instruction on how to calibrate the device’s stimulation to their tremor frequency and instructed to use the therapy as needed. An accelerometer on the device measured tremor power before and after a subset of therapy sessions. Therapy efficacy was quantified using (i) median improvement in tremor power and (ii) self-rated improvements in activities of daily living and quality of life as measured by an opt-in post-market survey sent to patients after 90 days of device use.

Results: 44 patients met the 90-day inclusion criterion for this analysis. Tremor power measurements from 1,751 therapy sessions showed that 57% of patients (25 of 44) experienced ≥50% improvement in tremor power. 18 of 44 patients completed the survey, with 61% (11 of 18) reporting that eating, drinking, and/or writing improved with therapy and 56% (10 of 18) reporting that quality of life improved with therapy. 3 of 44 patients reported minor adverse events (skin irritation or electrical burns) that resolved with temporary discontinuation of therapy and without medical intervention.

Conclusion: This early real-world evidence reinforces previous findings on efficacy and safety of TAPS. Real-world therapeutic efficacy was reproduced across objective accelerometer-measured tremor power improvements and subjective self-rated quality of life improvements, and was similar to efficacy observed in a clinical trial setting [3]. These results suggest that TAPS may be an attractive option for ET patients seeking symptomatic treatment with minimal side effects.

References: 1. Lin PT, Ross EK, Chidester P, et al. Noninvasive neuromodulation in essential tremor demonstrates relief in a sham-controlled pilot trial. Mov Disord John Wiley and Sons Inc.; Jul 1, 2018 p. 1182–1183. 2. Pahwa R, Dhall R, Ostrem J, et al. An Acute Randomized Controlled Trial of Noninvasive Peripheral Nerve Stimulation in Essential Tremor. Neuromodulation. Blackwell Publishing Inc.; Epub 2019. 3. Isaacson, S, Peckham, E, Tse, W, et al. Symptomatic relief in essential tremor with home use of non-invasive neuromodulation therapy. Mov Disord Clin Pract, 7: Abstract 195. Proceedings from PAN-MDS, Miami, 2020.

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