Objective: This post-market analysis evaluated Transcutaneous Afferent Patterned Stimulation (TAPS) therapy for management of upper limb essential tremor in a cohort of Veteran Affairs (VA) patients.

Background: TAPS is an on-demand, non-invasive neuromodulation therapy. Prior clinical and post-market studies have shown TAPS to be a safe and effective therapy for at-home ET symptom control [1-3].

Method: This analysis evaluated de-identified data from VA patients who used a prescription wrist-worn TAPS device (Cala Health, Burlingame, CA) at home for at least 30 days and completed ≥10 therapy sessions. Patients were given instructions on how to set up the device and calibrate the therapy to their tremor physiology. They were advised to use the therapy as needed. Device data included (i) timestamps for all therapy sessions and (ii) accelerometry data from a postural hold completed before and after stimulation for a pre-specified subset of therapy sessions. Each session’s pre- and post-therapy tremor was post-hoc classified as high, medium, or low according to percentiles of patient-specific pre-stimulation tremor power distributions. Therapy use was summarized using session counts per week. Therapy efficacy, for patients who had ≥10 sessions of valid motion data, was quantified using (i) median reduction in tremor power, (ii) frequency of tremor “relief” (i.e., ≥50% reduction in tremor when the pre-therapy tremor classification was “high”), and (iii) frequency of tremor “prevention” (i.e., maintaining a low tremor when the pre-therapy tremor classification was “low”).

Results: Fifty-eight VA patients (age 71 ± 10 years; mean ± 1SD) who met the primary inclusion criteria completed 5.5 ± 4.3 (mean ± 1 SD) sessions per week. Therapy prescriptions were primarily from neurologists (45%) and movement disorder specialists (38%). Twenty-four patients (completing 902 therapy sessions) met the additional inclusion criterion for efficacy analysis. For these 24 patients, TAPS provided a (i) median 51% reduction in tremor power (p=2.27e-6), (ii) average 71.7% rate of tremor “relief”, and (iii) average 72.1% rate of tremor “prevention”.

Conclusion: These data are consistent with findings from prior clinical and post-market studies [2,3], and suggest that TAPS therapy provides meaningful tremor reduction in cases of high tremor and continued tremor control in cases of low tremor.

References: 1. 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. 2. Isaacson S, Peckham E, Tse W, et al. Prospective Home-use Study on Non-invasive Neuromodulation Therapy for Essential Tremor. Tremor and Other Hyperkinetic Movements. 2020;10:29. DOI: http://doi.org/10.5334/tohm.59. 3. Rajagopal A, Rosenbluth K, Khosla D, Shin S, Samiian A. PND112 Real-World Evidence for Symptomatic Relief in Essential Tremor Using Transcutaneous Afferent Patterned Stimulation Therapy. Value in Health 23 (2020): S642-S643.

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