Real-World Evidence of Transcutaneous Afferent Patterned Stimulation for Essential Tremor

Abstract

Background: Transcutaneous afferent patterned stimulation (TAPS) is a prescription, wristworn device-delivered, non-invasive neuromodulation therapy for treatment of hand tremor in patients with essential tremor (ET). This retrospective post-market surveillance study evaluated real-world effectiveness of TAPS from patients using therapy on-demand for at least 90 days between August 2019 through June 2021.Methods: Demographics were summarized from TAPS prescriptions received from the patient's healthcare provider. Therapy usage and effectiveness were analyzed from device logs, which included tremor measurements from onboard motion sensors. Tremor history and patient-reported outcomes were assessed from a voluntary survey.Results: A total of 321 patients (average age 71 years, 32% female) met the criteria for this analysis, 216 of whom had tremor measurements available for analysis and 69 of whom completed the survey. Total usage period ranged from 90 to 663 days, with 28% of patients using the device for over one year. Patients used therapy 5.4 ± 4.5 (mean ± 1 standard deviation) times per week. TAPS reduced tremor power by 71% (geometric mean) across all sessions, with 59% of patients experiencing >50% tremor reduction after their sessions. Eighty-four percent (84%) of patients who returned the voluntary survey reported improvement in at least one of eating, drinking, or writing, and 65% of patients reported improvement in quality of life. Self-reported device-related safety complaints were consistent with adverse events in prior clinical trials.Discussion: Real-world evidence is consistent with prior clinical trials and confirms TAPS provides safe and effective tremor control for many patients with ET. Future work assessing multi-year safety and effectiveness would be valuable to extend these data.

Non-Invasive Transcutaneous Afferent Patterned Stimulation Therapy Offers Action Tremor Relief in Parkinson’s Disease

“…TAPS provided safe and effective relief of PD-associated action tremor, similar to results of previously reported relief of ET-associated action tremor [8][9][10][11]18], suggesting TAPS may be a valuable treatment option for both PD and ET patients with action tremor. Action tremor improvement was demonstrated across multiple 1 and 2 for MDS-UPDRS and BF-ADL ratings across all tasks and visits.…”

“…While chronic stimulation of VIM with deep brain stimulation (DBS) has been used to relieve upper limb motor symptoms in both essential tremor (ET) and PD [ 15 16 ], and both ET and PD patients are prescribed propranolol for action tremor control [ 17 ], to date TAPS has only been evaluated in patients with ET. Studies demonstrating the efficacy and safety of TAPS in ET include three randomized clinical trials (two completed studies randomized to sham [ 8 9 ] and an active study randomized to standard-of-care ( clinicaltrials.gov NCT05540626)) as well as two longitudinal home-use studies [ 11 18 ]. This study sought to evaluate the use of TAPS in PD patients with action tremor.…”

“…Studies demonstrating the efficacy and safety of TAPS in ET include three randomized clinical trials (two completed studies randomized to sham [8,9] and an active study randomized to standard-of-care (clinicaltrials. gov NCT05540626)) as well as two longitudinal home-use studies [11,18]. This study sought to evaluate the use of TAPS in PD patients with action tremor.…”

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

“…TAPS devices were authorized by the U.S. Food and Drug Administration (DEN170028) for the treatment of essential tremor symptoms, recent label expansion includes both ET and postural and kinetic hand tremors in Parkinson's disease [17,18]. TAPS devices measure each patient's unique tremor signature and deliver alternating bursts of stimulation pulses to the median and radial nerves at each patient's tremor frequency [19][20][21][22]. Patients use TAPS to relieve tremor symptoms when needed, typically when patients' tremors are worse or in preparation for activities requiring hand control.…”

“…While previous studies have demonstrated the effectiveness and safety of TAPS in open-label and shamcontrolled studies [19][20][21][22][23][24], randomized evidence with home use beyond in-office assessment or in comparison to standard of care remains lacking. The purpose of this study was to evaluate the clinical outcomes of adding TAPS to standard of care over a one-month period of home use.…”