Prospective home-use study on non-invasive neuromodulation therapy for essential tremor

Stuart H. Isaacson, Elizabeth Peckham, Winona Tse, Olga Waln, Christopher Way, Melita T. Petrossian, Nabila Dahodwala, Michael J. Soileau, Mark Lew, Cameron Dietiker, Nijee Luthra, Pinky Agarwal, Rohit Dhall, John Morgan, Nicole Calakos, Theresa A. Zesiewicz, Ejaz A. Shamim, Rajeev Kumar, Peter Lewitt, Holly A. ShillAdam Simmons, Fernando L. Pagan, Pravin Khemani, Jessica Tate, Brian Maddux, Lan Luo, William Ondo, Mark Hallett, Apoorva Rajagopal, Paula Chidester, Kathryn H. Rosenbluth, Scott L. Delp, Rajesh Pahwa

Research output: Contribution to journalArticle

Abstract

Highlights This prospective study is one of the largest clinical trials in essential tremor to date. Study findings suggest that individualized non-invasive neuromodulation therapy used repeatedly at home over three months results in safe and effective hand tremor reduction and improves quality of life for many essential tremor patients. Background: Two previous randomized, controlled, single-session trials demonstrated efficacy of non-invasive neuromodulation therapy targeting the median and radial nerves for reducing hand tremor. This current study evaluated efficacy and safety of the therapy over three months of repeated home use. Methods: This was a prospective, open-label, post-clearance, single-arm study with 263 patients enrolled across 26 sites. Patients were instructed to use the therapy twice daily for three months. Pre-specified co-primary endpoints were improvements on clinician-rated Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) and patient-rated Bain & Findley Activities of Daily Living (BF-ADL) dominant hand scores. Other endpoints included improvement in the tremor power detected by an accelerometer on the therapeutic device, Clinical and Patient Global Impression scores (CGI-I, PGI-I), and Quality of Life in Essential Tremor (QUEST) survey. Results: 205 patients completed the study. The co-primary endpoints were met (p≪0.0001), with 62% (TET-RAS) and 68% (BF-ADL) of ‘severe’ or ‘moderate’ patients improving to ‘mild’ or ‘slight’. Clinicians (CGI-I) reported improvement in 68% of patients, 60% (PGI-I) of patients reported improvement, and QUEST improved (p = 0.0019). Wrist-worn accelerometer recordings before and after 21,806 therapy sessions showed that 92% of patients improved, and 54% of patients experienced ≥50% improvement in tremor power. Device-re-lated adverse events (e.g., wrist discomfort, skin irritation, pain) occurred in 18% of patients. No device-re-lated serious adverse events were reported. Discussion: This study suggests that non-invasive neuromodulation therapy used repeatedly at home over three months results in safe and effective hand tremor reduction in many essential tremor patients.

Original languageEnglish (US)
Article number29
Pages (from-to)1-16
Number of pages16
JournalTremor and Other Hyperkinetic Movements
Volume10
Issue number1
DOIs
StatePublished - 2020

Keywords

  • Clinical trials
  • Neuromodulation
  • Non-invasive
  • Stimulation
  • Tremor

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Medicine(all)

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    Isaacson, S. H., Peckham, E., Tse, W., Waln, O., Way, C., Petrossian, M. T., Dahodwala, N., Soileau, M. J., Lew, M., Dietiker, C., Luthra, N., Agarwal, P., Dhall, R., Morgan, J., Calakos, N., Zesiewicz, T. A., Shamim, E. A., Kumar, R., Lewitt, P., ... Pahwa, R. (2020). Prospective home-use study on non-invasive neuromodulation therapy for essential tremor. Tremor and Other Hyperkinetic Movements, 10(1), 1-16. [29]. https://doi.org/10.5334/tohm.59