Clinical and Economic Outcomes of Transcutaneous Afferent Patterned Stimulation for Essential Tremor

TAPS® therapy (Cala Health) delivers transcutaneous afferent patterned stimulation through a noninvasive, wrist-worn neuromodulation device for the treatment of hand tremor in patients with essential tremor (ET). Although previous studies have demonstrated its effectiveness and safety, real-world evidence regarding its long-term clinical outcomes and economic impact remains limited.

To evaluate the long-term clinical effectiveness and the healthcare resource utilization and cost impact of TAPS in patients with ET treated in real-world settings.

Patients who completed a 1-month randomized pragmatic phase comparing TAPS with standard of care entered 12 months of open-label home use. Clinical outcomes were assessed via device-based motion sensors and the Bain & Findley Activities of Daily Living (BF-ADL) upper-limb scale at baseline and every 3 months. Healthcare resource utilization and costs over the 12-month TAPS treatment period were compared with those during the 12 months before TAPS initiation and with a propensity-score-matched external control arm (ECA) derived from a large US commercial and Medicare Advantage claims database.

Among 225 patients who used TAPS therapy for 12 months, daily functioning improved, with the mean BF-ADL score decreasing from 17.2 to 15.8 (P < .003). Device-measured tremor power decreased by more than 50% (P < .001). No serious device-related adverse events were reported. In the ECA analysis, 153 TAPS-treated patients were matched to 306 ECA patients. Compared with baseline, TAPS-treated patients experienced significant reductions in ET-related healthcare costs ($440 decrease; P < .0001), ET-related medication use (15% fewer patients; P < .01), and ambulatory and office visits (~0.3 fewer each; P < .05). These reductions were significantly greater than those observed in the ECA (all P < .05).

This is the largest and longest prospective ET study to jointly assess tremor severity, daily function, and healthcare economic outcomes. The sustained clinical benefits observed with TAPS therapy, together with reductions in ET-related healthcare utilization and costs, support TAPS as a noninvasive treatment option for adults with ET.

Over 12 months of real-world use, TAPS reduced tremor severity, improved daily functioning, and lowered ET-related healthcare resource utilization and costs.