Comparative Effectiveness of Transcutaneous Afferent Patterned Stimulation Therapy for Essential Tremor: A Randomized Pragmatic Clinical Trial

Abstract

Background: Transcutaneous afferent patterned stimulation (TAPS) is a wrist-worn, non-invasive therapy delivering calibrated stimulation to the median and radial nerves. While the efficacy and safety of TAPS therapy for essential tremor (ET) have been demonstrated, current evidence supporting therapeutic benefits of TAPS versus standard of care (SOC) is lacking. This prospective study evaluated the clinical benefit of adding TAPS treatment to SOC versus SOC alone. Methods: This randomized, controlled, pragmatic trial recruited patients from a large health plan’s Commercially Insured and Medicare Advantage population. 310 patients were randomized 1:1 to one month of treatment with TAPS (TX) or standard of care (SOC). The pre-specified endpoints were changes in tremor power measured by motion sensors (primary) and improvement in Bain & Findley Activities of Daily Living (BF-ADL) upper limb scores reported (secondary) between TX and SOC at one month. Results: 276 patients completed the one-month endpoints (n=133 TX, n=143 SOC). The study met the primary and secondary endpoints, with significantly reduced tremor power in TX than SOC (0.017 (0.003) versus 0.08 (0.014) (m/s2)2; geometric mean (SE); p < 0.0001) and greater improvement in the BF-ADL score in TX than SOC (1.6 (0.43) vs 0.2 (0.37) points; mean (SE); p < 0.05). 82% of TX patients experienced tremor improvement from before to after therapy. No serious device-related adverse events were reported. Discussion: This trial demonstrates that TAPS significantly improves tremor power and BF-ADLs in patients with ET compared to SOC over one month of home use. Highlights This study found that TAPS significantly improves tremor power and BF-ADL scores in patients with ET compared to SOC over one month of home use. This real-world study suggests that non-invasive TAPS therapy is a safe and valuable treatment option for patients with ET.