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Reliability of Measurements Using Ocular Response Analyzer as a Screening Tonometer and Corneal Hysteresis Values in the Presence or Absence of Glaucomatous Changes in Fundus
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      Prospective Home-use Study on Non-invasive Neuromodulation Therapy for Essential Tremor

      research-article
      Author(s): , MD 1 , , DO 2 , , MD 3 , , MD 4 , , DO 5 , , MD 6 , , MD, MSc 7 , , MD 8 , , MD 9 , , MD 10 , , MD 10 , , MD, FAAN 11 , , MD, MSPH 12 , , MD, PhD 13 , , MD, PhD 14 , , MD 15 , , MD, MS, MBA, FAAN 16 , , MD 17 , , MD 18 , , MD, FAAN 19 , , MD 20 , , MD 21 , , MD 22 , , MD 23 , , MD 24 , , MD, MS 25 , , MD 4 , , MD 26 , , PhD 27 , , MS 27 , , PhD 27 , , PhD 28 , , MD 29
      Publication date (Electronic, pub):
      Journal: Tremor and Other Hyperkinetic Movements
      Publisher: Ubiquity Press
      Keywords: clinical trials, tremor, neuromodulation, stimulation, non-invasive

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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.

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          Most cited references53

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          How common is the most common adult movement disorder? Update on the worldwide prevalence of essential tremor.

          Elan Louis, Joaquim Ferreira (2010)
          Essential tremor (ET) is among the more prevalent neurological disorders, yet prevalence estimates have varied enormously, making it difficult to establish prevalence with precision. We: (1) reviewed the worldwide prevalence of ET in population-based epidemiological studies, (2) derived as precisely as possible an estimate of disease prevalence, and (3) examined trends and important differences across studies. We identified 28 population-based prevalence studies (19 countries). In a meta-analysis, pooled prevalence (all ages) = 0.9%, with statistically significant heterogeneity across studies (I(2) = 99%, P or= 65 years) = 4.6%, and in additional descriptive analyses, median crude prevalence (age >or= 60-65) = 6.3%. In one study of those age >or= 95 years, crude prevalence = 21.7%. Several studies reported ethnic differences in prevalence, although more studies are needed. Greater than one-third of studies show a gender difference, with most demonstrating a higher prevalence among men. This possible gender preference is interesting given clinical, epidemiological, and pathological associations between ET and Parkinson's disease. Precise prevalence estimates such as those we provide are important because they form the numerical basis for planned public health initiatives, provide data on the background occurrence of disease for family studies, and offer clues about the existence of environmental or underlying biological factors of possible mechanistic importance. (c) 2010 Movement Disorder Society.
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            Essential Tremor

            Dietrich Haubenberger, Mark Hallett, Caren G. Solomon (2018)
            Article 0 comments Cited 85 times – based on 0 reviews     Review now
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              Practice parameter: therapies for essential tremor: report of the Quality Standards Subcommittee of the American Academy of Neurology.

              T A Zesiewicz, R Elble, E D Louis … (2005)
              Essential tremor (ET) is one of the most common tremor disorders in adults and is characterized by kinetic and postural tremor. To develop this practice parameter, the authors reviewed available evidence regarding initiation of pharmacologic and surgical therapies, duration of their effect, their relative benefits and risks, and the strength of evidence supporting their use. A literature review using MEDLINE, EMBASE, Science Citation Index, and CINAHL was performed to identify clinical trials in patients with ET published between 1966 and August 2004. Articles were classified according to a four-tiered level of evidence scheme and recommendations were based on the level of evidence. Propranolol and primidone reduce limb tremor (Level A). Alprazolam, atenolol, gabapentin (monotherapy), sotalol, and topiramate are probably effective in reducing limb tremor (Level B). Limited studies suggest that propranolol reduces head tremor (Level B). Clonazepam, clozapine, nadolol, and nimodipine possibly reduce limb tremor (Level C). Botulinum toxin A may reduce hand tremor but is associated with dose-dependent hand weakness (Level C). Botulinum toxin A may reduce head tremor (Level C) and voice tremor (Level C), but breathiness, hoarseness, and swallowing difficulties may occur in the treatment of voice tremor. Chronic deep brain stimulation (DBS) (Level C) and thalamotomy (Level C) are highly efficacious in reducing tremor. Each procedure carries a small risk of major complications. Some adverse events from DBS may resolve with time or with adjustment of stimulator settings. There is insufficient evidence regarding the surgical treatment of head and voice tremor and the use of gamma knife thalamotomy (Level U). Additional prospective, double-blind, placebo-controlled trials are needed to better determine the efficacy and side effects of pharmacologic and surgical treatments of ET.
              Article 0 comments Cited 72 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                Scott L. Delp
                Rajesh Pahwa
                Journal
                Journal ID (nlm-ta): Tremor Other Hyperkinet Mov (N Y)
                Journal ID (iso-abbrev): Tremor Other Hyperkinet Mov (N Y)
                Journal ID (issn): 2160-8288
                Title: Tremor and Other Hyperkinetic Movements
                Publisher: Ubiquity Press
                ISSN (Electronic): 2160-8288
                Publication date (Electronic, pub): 14 August 2020
                Publication date Collection: 2020
                Volume: 10
                Electronic Location Identifier: 29
                Affiliations
                [1 ]Parkinson’s Disease and Movement Disorders of Boca Raton, Boca Raton, FL, US
                [2 ]Central Texas Neurology Consultants, Round Rock, TX, US
                [3 ]Mount Sinai Hospital, Department of Neurology, New York, NY, US
                [4 ]Houston Methodist, Department of Neurology, Houston, TX, US
                [5 ]Parkinson’s Institute and Clinical Center, Mountain View, CA, US
                [6 ]Pacific Neuroscience Institute, Pacific Movement Disorders Center, Santa Monica, CA, US
                [7 ]University of Pennsylvania, Department of Neurology, Philadelphia, PA, US
                [8 ]Texas Movement Disorders Specialists, Georgetown, TX, US
                [9 ]University of Southern California, Department of Neurology, Los Angeles, CA, US
                [10 ]University of California San Francisco, Movement Disorder and Neuromodulation Center, San Francisco, CA, US
                [11 ]EvergreenHealth, Department of Neurology, Kirkland, WA, US
                [12 ]University of Arkansas for Medical Sciences, Department of Neurology, Little Rock, AR, US
                [13 ]Augusta University, Department of Neurology, Augusta, GA, US
                [14 ]Duke University School of Medicine, Department of Neurology, Durham, NC, US
                [15 ]University of South Florida Health, Department of Neurology, Tampa, FL, US
                [16 ]Kaiser Permanente MidAtlantic States, Department of Neurology, MidAtlantic Permanente Research Institute, Largo, MD, US
                [17 ]Rocky Mountain Movement Disorders Center, Englewood, CO, US
                [18 ]Henry Ford Health System, Department of Neurology, West Bloomfield, MI, US
                [19 ]Barrow Neurological Institute, Department of Neurology, Phoenix, AZ, US
                [20 ]Hospital for Special Care, Department of Research, New Britain, CT, US
                [21 ]Georgetown University Medical Center, Department of Neurology, Washington DC, US
                [22 ]Swedish Neuroscience Institute, Department of Neurology, Seattle, WA, US
                [23 ]Wake Forest Baptist Health, Department of Neurology, Winston-Salem, NC, US
                [24 ]Riverhills Neuroscience, Cincinnati, OH, US
                [25 ]Beth Israel Deaconess Medical Center, Harvard Medical School, Department of Neurology, Boston, MA, US
                [26 ]National Institute of Neurological Disorders and Stroke, Human Motor Control Section, Bethesda, MD, US
                [27 ]Cala Health, Burlingame, CA, US
                [28 ]Stanford University, Department of Bioengineering, Stanford, CA, US
                [29 ]University of Kansas Medical Center, Department of Neurology, Kansas City, KS, US
                Author notes
                Corresponding authors: Rajesh Pahwa, MD ( RPAHWA@ 123456kumc.edu ); Scott L. Delp, PhD ( delp@ 123456stanford.edu )
                Author information
                https://orcid.org/0000-0002-7915-7048
                Article
                DOI: 10.5334/tohm.59
                PMC ID: 7427656
                PubMed ID: 32864188
                SO-VID: f86ff550-5c33-4a63-b100-eb8f03d8f9a2
                Copyright © Copyright: © 2020 The Author(s)
                License:

                This is an open-access article distributed under the terms of the Creative Commons Attribution 4.0 International License (CC-BY 4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. See http://creativecommons.org/licenses/by/4.0/.

                History
                Date received : 10 April 2020
                Date accepted : 14 June 2020
                Funding
                This study was funded by Cala Health, Inc.
                Categories
                Subject: Article

                Keywords: clinical trials,tremor,neuromodulation,stimulation,non-invasive
                Data availability:
                Keywords: clinical trials, tremor, neuromodulation, stimulation, non-invasive

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