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

Tremor and Other Hyperkinetic Movements

article

Salima Brillman¹  Kalea Colletta²  Sally Borucki³  Peter T. Lin⁴  Olga Waln⁵  Melita Petrossian⁶  Pravin Khemani⁷  Apoorva Rajagopal⁸  Kathryn H. Rosenbluth⁸  Dhira Khosla⁸ 

[1] Parkinson’s Disease and Movement Disorders Center of Silicon Valley;Department of Neurology, Edward Hines Jr. VA Hospital;Department of Neurology, Temple VA Medical Center;Valley Parkinson Clinic;Houston Methodist Neurological Institute;Pacific Neuroscience Institute, Pacific Movement Disorders Center;Swedish Neuroscience Institute;Cala Health Inc

关键词: peripheral neuromodulation;    essential tremor;    real-world evidence;    remote sensing;    transcutaneous afferent patterned stimulation;   

DOI  :  10.5334/tohm.715

学科分类：社会科学、人文和艺术（综合）

来源: Ubiquity Press

【 摘 要 】

Background: Transcutaneous afferent patterned stimulation (TAPS) is a prescription, wrist-worn 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: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.

【 授权许可】

CC BY