Real-World Evaluation of TAPS Therapy

Real-world performance of TAPS therapy, delivered with a wrist-worn device (Cala Trio™, Cala Health, San Mateo, CA, USA), was analyzed for patients who had a diagnosis of ET reported by their prescribing HCP, had used TAPS therapy for at least 90 days, and had a minimum of 10 sessions in device logs. The TAPS device consisted of a (1) wrist-worn stimulator with a triaxial accelerometer that generated the TAPS waveform and logged all device-collected data, (2) detachable wrist band with electrodes configured to target the median and radial nerves, and (3) cloud-connected base station that charged the stimulator and securely transmitted all device data to a centralized database (Figure 1A). The instructions for use provided with the device instructed patients on how to calibrate and use TAPS therapy.
Demographic information and tremor history were gathered from the HCP prescription form and from a voluntary survey (eTable 1, in Supplemental materials) sent to patients after 90 days of therapy use (Figure 1B). Usage and effectiveness information were compiled from device logs, which included (1) timestamps of all sessions; and (2) device-prompted postural hold tremor accelerometry measurements and (3) patients’ self-rating of post-session impression of tremor (improved, no change, worsened) collected before and after the first forty therapy sessions and every seventh session thereafter (Figure 1B).