Prospective Home-use Study on Non-invasive Neuromodulation Therapy for Essential Tremor.

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

Journal: Tremor and other hyperkinetic movements (New York, N.Y.) 2021;10():29

PMID: 32864188

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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% (TETRAS) 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-related adverse events (e.g., wrist discomfort, skin irritation, pain) occurred in 18% of patients. No device-related 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.

Address: Parkinson's Disease and Movement Disorders of Boca Raton, Boca Raton, FL, US.; Central Texas Neurology Consultants, Round Rock, TX, US.; Mount Sinai Hospital, Department of Neurology, New York, NY, US.; Houston Methodist, Department of Neurology, Houston, TX, US.; Parkinson's Institute and Clinical Center, Mountain View, CA, US.; Pacific Neuroscience Institute, Pacific Movement Disorders Center, Santa Monica, CA, US.; University of Pennsylvania, Department of Neurology, Philadelphia, PA, US.; Texas Movement Disorders Specialists, Georgetown, TX, US.; University of Southern California, Department of Neurology, Los Angeles, CA, US.; University of California San Francisco, Movement Disorder and Neuromodulation Center, San Francisco, CA, US.; EvergreenHealth, Department of Neurology, Kirkland, WA, US.; University of Arkansas for Medical Sciences, Department of Neurology, Little Rock, AR, US.; Augusta University, Department of Neurology, Augusta, GA, US.; Duke University School of Medicine, Department of Neurology, Durham, NC, US.; University of South Florida Health, Department of Neurology, Tampa, FL, US.; Kaiser Permanente MidAtlantic States, Department of Neurology, MidAtlantic Permanente Research Institute, Largo, MD, US.; Rocky Mountain Movement Disorders Center, Englewood, CO, US.; Henry Ford Health System, Department of Neurology, West Bloomfield, MI, US.; Barrow Neurological Institute, Department of Neurology, Phoenix, AZ, US.; Hospital for Special Care, Department of Research, New Britain, CT, US.; Georgetown University Medical Center, Department of Neurology, Washington DC, US.; Swedish Neuroscience Institute, Department of Neurology, Seattle, WA, US.; Wake Forest Baptist Health, Department of Neurology, Winston-Salem, NC, US.; Riverhills Neuroscience, Cincinnati, OH, US.; Beth Israel Deaconess Medical Center, Harvard Medical School, Department of Neurology, Boston, MA, US.; National Institute of Neurological Disorders and Stroke, Human Motor Control Section, Bethesda, MD, US.; Cala Health, Burlingame, CA, US.; Stanford University, Department of Bioengineering, Stanford, CA, US.; University of Kansas Medical Center, Department of Neurology, Kansas City, KS, US.

DOI: 10.5334/tohm.59

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MeSH Terms: Adult, Aged, Aged, 80 and over, Electric Stimulation Therapy, Essential Tremor, Female, Hand, Humans, Male, Median Nerve, Middle Aged, Outcome Assessment, Health Care, Prospective Studies, Radial Nerve, Young Adult