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      International Consensus Based Review and Recommendations for Minimum Reporting Standards in Research on Transcutaneous Vagus Nerve Stimulation (Version 2020)

      review-article
      1 , 2 , 3 , 4 , 5 , 6 , 7 , 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 2 , 30 , 31 , 32 , 33 , 13 , 34 , 35 , 36 , 37 , 38 , 11 , 39 , 40 , 41 , 42 , 43 , 44 , 10 , 45 , 46 , 13 , 47 , 48 , 49 , 50 , 51 , 5 , 52 , 34 , 53 , 37 , 14 , 54 , 47 , 55 , 56 , 44 , 57 , 58 , 59 , 60 , 61 , 62 , 63 , 26 , 27 , 64 , 65 , 66 , 67 , 68 , 69 , 70 , 71 , 72 , 73 , 74 , 75 , 76 , 2 , 59 , 60 , 77 , 78 , 28 , 29 , 40 , 79 , 80 , 81 , 82 , 83 , 84 , 80 , 85 , 66 , 86 , 87 , 70 , 71 , 57 , 88 , *
      Frontiers in Human Neuroscience
      Frontiers Media S.A.
      transcutaneous vagus nerve stimulation, minimum reporting standards, guidelines & recommendations, transcutaneous auricular vagus nerve stimulation, transcutaneous cervical vagus nerve stimulation

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          Abstract

          Given its non-invasive nature, there is increasing interest in the use of transcutaneous vagus nerve stimulation (tVNS) across basic, translational and clinical research. Contemporaneously, tVNS can be achieved by stimulating either the auricular branch or the cervical bundle of the vagus nerve, referred to as transcutaneous auricular vagus nerve stimulation(VNS) and transcutaneous cervical VNS, respectively. In order to advance the field in a systematic manner, studies using these technologies need to adequately report sufficient methodological detail to enable comparison of results between studies, replication of studies, as well as enhancing study participant safety. We systematically reviewed the existing tVNS literature to evaluate current reporting practices. Based on this review, and consensus among participating authors, we propose a set of minimal reporting items to guide future tVNS studies. The suggested items address specific technical aspects of the device and stimulation parameters. We also cover general recommendations including inclusion and exclusion criteria for participants, outcome parameters and the detailed reporting of side effects. Furthermore, we review strategies used to identify the optimal stimulation parameters for a given research setting and summarize ongoing developments in animal research with potential implications for the application of tVNS in humans. Finally, we discuss the potential of tVNS in future research as well as the associated challenges across several disciplines in research and clinical practice.

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          The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies.

          Much of biomedical research is observational. The reporting of such research is often inadequate, which hampers the assessment of its strengths and weaknesses and of a study's generalizability. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Initiative developed recommendations on what should be included in an accurate and complete report of an observational study. We defined the scope of the recommendations to cover three main study designs: cohort, case-control, and cross-sectional studies. We convened a 2-day workshop in September 2004, with methodologists, researchers, and journal editors to draft a checklist of items. This list was subsequently revised during several meetings of the coordinating group and in e-mail discussions with the larger group of STROBE contributors, taking into account empirical evidence and methodological considerations. The workshop and the subsequent iterative process of consultation and revision resulted in a checklist of 22 items (the STROBE Statement) that relate to the title, abstract, introduction, methods, results, and discussion sections of articles. Eighteen items are common to all three study designs and four are specific for cohort, case-control, or cross-sectional studies. A detailed Explanation and Elaboration document is published separately and is freely available on the web sites of PLoS Medicine, Annals of Internal Medicine, and Epidemiology. We hope that the STROBE Statement will contribute to improving the quality of reporting of observational studies.
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            Electrical stimulation of excitable tissue: design of efficacious and safe protocols.

            The physical basis for electrical stimulation of excitable tissue, as used by electrophysiological researchers and clinicians in functional electrical stimulation, is presented with emphasis on the fundamental mechanisms of charge injection at the electrode/tissue interface. Faradaic and non-Faradaic charge transfer mechanisms are presented and contrasted. An electrical model of the electrode/tissue interface is given. The physical basis for the origin of electrode potentials is given. Various methods of controlling charge delivery during pulsing are presented. Electrochemical reversibility is discussed. Commonly used electrode materials and stimulation protocols are reviewed in terms of stimulation efficacy and safety. Principles of stimulation of excitable tissue are reviewed with emphasis on efficacy and safety. Mechanisms of damage to tissue and the electrode are reviewed.
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              Decision making, the P3, and the locus coeruleus-norepinephrine system.

              Psychologists and neuroscientists have had a long-standing interest in the P3, a prominent component of the event-related brain potential. This review aims to integrate knowledge regarding the neural basis of the P3 and to elucidate its functional role in information processing. The authors review evidence suggesting that the P3 reflects phasic activity of the neuromodulatory locus coeruleus-norepinephrine (LC-NE) system. They discuss the P3 literature in the light of empirical findings and a recent theory regarding the information-processing function of the LC-NE phasic response. The theoretical framework emerging from this research synthesis suggests that the P3 reflects the response of the LC-NE system to the outcome of internal decision-making processes and the consequent effects of noradrenergic potentiation of information processing. Copyright 2005 APA, all rights reserved.
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                Journal
                Front Hum Neurosci
                Front Hum Neurosci
                Front. Hum. Neurosci.
                Frontiers in Human Neuroscience
                Frontiers Media S.A.
                1662-5161
                23 March 2021
                2020
                : 14
                : 568051
                Affiliations
                [1] 1Department of Gastroenterology, University Hospitals of North Midlands NHS Trust , Stoke on Trent, United Kingdom
                [2] 2Department of Neurology, Epilepsy Center Frankfurt Rhine-Main, Goethe-University Frankfurt , Frankfurt am Main, Germany
                [3] 3Scientific Institute, IRCCS E. Medea , Pasian di Prato, Italy
                [4] 4Department of Neuroscience, Physiology and Pharmacology, Centre for Cardiovascular and Metabolic Neuroscience, University College London , London, United Kingdom
                [5] 5Institute for Neuromodulation and Neurotechnology, University Hospital and University of Tuebingen , Tuebingen, Germany
                [6] 6Department of Psychiatry, Psychotherapy and Psychosomatics, Medical Faculty, University of Augsburg , Augsburg, Germany
                [7] 7Department of Psychiatry and Psychotherapy, University Hospital, LMU Munich , Munich, Germany
                [8] 8Laboratory for Biological Psychology, Faculty of Psychology and Educational Sciences, University of Leuven , Leuven, Belgium
                [9] 9Leibniz Institute for Neurobiology , Magdeburg, Germany
                [10] 10Department of Neurology, Institute for Neuroscience, 4Brain, Ghent University Hospital , Gent, Belgium
                [11] 11Sheffield Institute for Translational Neuroscience (SITraN), University of Sheffield , Sheffield, United Kingdom
                [12] 12Clinical Psychology and the Leiden Institute of Brain and Cognition, Leiden University , Leiden, Netherlands
                [13] 13Department of Psychiatry, Medical University of South Carolina , Charleston, SC, United States
                [14] 14Department of Biological Psychology and Affective Science, Faculty of Human Sciences, University of Potsdam , Potsdam, Germany
                [15] 15Migraine and Headache Clinic Koenigstein , Königstein im Taunus, Germany
                [16] 16Cognitive Neurophysiology, Department of Child and Adolescent Psychiatry, Faculty of Medicine, TU Dresden , Dresden, Germany
                [17] 17Utah State University , Logan, UT, United States
                [18] 18NORMENT, Division of Mental Health and Addiction, University of Oslo and Oslo University Hospital , Oslo, Norway
                [19] 19Department of Psychology, University of Oslo , Oslo, Norway
                [20] 20KG Jebsen Centre for Neurodevelopmental Disorders, University of Oslo , Oslo, Norway
                [21] 21Medical Faculty, Institute of Cognitive Neurology and Dementia Research, Otto-von-Guericke University , Magdeburg, Germany
                [22] 22Institute of Cognitive Neuroscience, University College London , London, United Kingdom
                [23] 23Center for Behavioral Brain Sciences Magdeburg (CBBS), Otto-von-Guericke University , Magdeburg, Germany
                [24] 24Department of Pediatric Neuroscience, Fondazione IRCCS Istituto Neurologico Carlo Besta , Milan, Italy
                [25] 25Pain and Integrative Neuroscience Branch, National Center for Complementary and Integrative Health, NIH , Bethesda, MD, United States
                [26] 26Department of Internal Medicine, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico , Milan, Italy
                [27] 27Department of Clinical Sciences and Community Health, University of Milan , Milan, Italy
                [28] 28Institute of Electrodynamics, Microwave and Circuit Engineering, TU Wien , Vienna, Austria
                [29] 29SzeleSTIM GmbH , Vienna, Austria
                [30] 30Unit of Neurology, Neurophysiology, Neurobiology, Department of Medicine, Università Campus Bio-Medico di Roma , Rome, Italy
                [31] 31Faculty of Biology and Faculty of Optics, Complutense University of Madrid and Institute for Health Research, San Carlos Clinical Hospital (IdISSC) , Madrid, Spain
                [32] 32Translational Medicine and Therapeutics, Barts and The London School of Medicine and Dentistry, William Harvey Research Institute, Queen Mary University of London , London, United Kingdom
                [33] 33Department of Pharmaceutical Sciences, School of Biosciences and Biotechnology, Babasaheb Bhimrao Ambedkar University (A Central University) , Lucknow, India
                [34] 34Department of Biological Psychology, Clinical Psychology and Psychotherapy, University of Würzburg , Würzburg, Germany
                [35] 35Division of Nuclear Medicine and Molecular Imaging, Department of Radiology, Massachusetts General Hospital and Harvard Medical School , Boston, MA, United States
                [36] 36Faculty of Health, Medicine and Life Sciences, School for Mental Health and Neuroscience, Alzheimer Centre Limburg, Maastricht University , Maastricht, Netherlands
                [37] 37Research Group Health Psychology, Faculty of Psychology and Educational Sciences, University of Leuven , Leuven, Belgium
                [38] 38Headache Research Unit, Department of Neurology-Citadelle Hospital, University of Liège , Liège, Belgium
                [39] 39Functional Imaging Lab, Department of Radiology, Guang An Men Hospital, China Academy of Chinese Medical Sciences , Beijing, China
                [40] 40School of Biomedical Science, Faculty of Biological Science, University of Leeds , Leeds, United Kingdom
                [41] 41Division for Vascular Surgery, Department of Surgery, Medical University of Vienna , Vienna, Austria
                [42] 42Department of Psychological Science, University of California, Irvine , Irvine, CA, United States
                [43] 43Institute for Cognitive Neurology and Dementia Research, Otto-von-Guericke-University Magdeburg , Magdeburg, Germany
                [44] 44Neuromodulatory Networks, Leibniz Institute for Neurobiology , Magdeburg, Germany
                [45] 45Clinical and Cognitive Psychology and the Leiden Institute of Brain and Cognition, Leiden University , Leiden, Netherlands
                [46] 46NeuroV̇ASQ̇ - Integrative Physiology Laboratory, Faculty of Physical Education, University of Brasilia , Brasilia, Brazil
                [47] 47Department of Anatomy, Faculty of Medicine, Mersin University , Mersin, Turkey
                [48] 48Mental Health and Wellbeing Research Group, Vrije Universiteit Brussel , Brussels, Belgium
                [49] 49Faculty of Health Care, University College Odisee , Aalst, Belgium
                [50] 50Division of Epileptology, Fondazione IRCCS Istituto Neurologico C. Besta , Milan, Italy
                [51] 51Department of Neurosurgery, University of Tübingen , Tübingen, Germany
                [52] 52Department of Biomedical Engineering, City College of New York , New York, NY, United States
                [53] 53Department of Psychology, Education and Child Studies, Erasmus University Rotterdam , Rotterdam, Netherlands
                [54] 54Faculty of Health Sciences Brandenburg, University of Potsdam , Potsdam, Germany
                [55] 55Deutsches Zentrum für Neurodegenerative Erkrankungen (DZNE) , Magdeburg, Germany
                [56] 56Center for Behavioral Brain Sciences, Otto-von-Guericke University , Magdeburg, Germany
                [57] 57University Hospital of Child and Adolescent Psychiatry and Psychotherapy, University of Bern , Bern, Switzerland
                [58] 58Section for Translational Psychobiology in Child and Adolescent Psychiatry, Department of Child and Adolescent Psychiatry, Centre for Psychosocial Medicine, University of Heidelberg , Heidelberg, Germany
                [59] 59Division of Endocrinology and Diabetology, Medical Faculty, Heinrich-Heine University Düsseldorf , Düsseldorf, Germany
                [60] 60Institute for Clinical Diabetology, German Diabetes Center, Leibniz Center for Diabetes Research at Heinrich Heine University , Düsseldorf, Germany
                [61] 61German Center for Diabetes Research , Munich, Germany
                [62] 62Department of Psychology, College of Liberal Arts, University of Minnesota , Minneapolis, MN, United States
                [63] 63Department of Anesthesiology, Center for Pain Medicine, University of California, San Diego Health System , La Jolla, CA, United States
                [64] 64Department of Psychiatry and Psychotherapy, University of Göttingen , Göttingen, Germany
                [65] 65Laboratory of Systems Neuroscience and Imaging in Psychiatry (SNIPLab), University of Göttingen , Göttingen, Germany
                [66] 66Department of Psychiatry and Psychotherapy, University of Tübingen , Tübingen, Germany
                [67] 67Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences , Beijing, China
                [68] 68Department of Psychology, University of Greifswald , Greifswald, Germany
                [69] 69Department of Psychiatry, University of Pittsburgh School of Medicine, UPMC Western Psychiatric Hospital , Pittsburgh, PA, United States
                [70] 70Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital , Charlestown, MA, United States
                [71] 71Department of Radiology, Logan University , Chesterfield, MO, United States
                [72] 72Cognitive Psychology Unit, Institute of Psychology, Leiden University , Leiden, Netherlands
                [73] 73Leiden Institute for Brain and Cognition , Leiden, Netherlands
                [74] 74Department of Developmental Psychology and Socialisation, University of Padova , Padova, Italy
                [75] 75Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School , Charlestown, MA, United States
                [76] 76Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School , Boston, MA, United States
                [77] 77Heart Rhythm Institute, University of Oklahoma Health Sciences Center , Oklahoma City, OK, United States
                [78] 78Faculty of Biological Science, School of Biomedical Science, University of Leeds , Leeds, United Kingdom
                [79] 79Department of Surgery, University Hospital Bonn , Bonn, Germany
                [80] 80Department of Performance Psychology, Institute of Psychology, Deutsche Sporthochschule , Köln, Germany
                [81] 81Department of Anesthesiology, University Medicine Greifswald , Greifswald, Germany
                [82] 82Department of Anesthesia, McMaster University , Hamilton, ON, Canada
                [83] 83Laboratory of Functional Neurovascular Diagnostics, AG Early Diagnosis of Dementia, Department of Psychiatry, Psychosomatics and Psychotherapy, University Clinic Würzburg , Würzburg, Germany
                [84] 84Department of Neurology, Otto-von-Guericke University , Magdeburg, Germany
                [85] 85Department of Social and Health Psychology, Institute of Psychology, Deutsche Sporthochschule , Köln, Germany
                [86] 86Department of Epidemiology and Public Health, Faculty of Medicine, University of Ostrava , Ostrava, Czechia
                [87] 87Department of Human Movement Studies, Faculty of Education, University of Ostrava , Ostrava, Czechia
                [88] 88Section for Experimental Child and Adolescent Psychiatry, Department of Child and Adolescent Psychiatry, Centre for Psychosocial Medicine, University of Heidelberg , Heidelberg, Germany
                Author notes

                Edited by: Yusuf Ozgur Cakmak, University of Otago, New Zealand

                Reviewed by: Chunhong Liu, Capital Medical University, China; Teresa Schuhmann, Maastricht University, Netherlands

                *Correspondence: Julian Koenig julian.koenig@ 123456med.uni-heidelberg.de

                This article was submitted to Brain Imaging and Stimulation, a section of the journal Frontiers in Human Neuroscience

                Article
                10.3389/fnhum.2020.568051
                8040977
                33854421
                aacc00d4-2b77-4dc8-9aef-2467764ba123
                Copyright © 2021 Farmer, Strzelczyk, Finisguerra, Gourine, Gharabaghi, Hasan, Burger, Jaramillo, Mertens, Majid, Verkuil, Badran, Ventura-Bort, Gaul, Beste, Warren, Quintana, Hämmerer, Freri, Frangos, Tobaldini, Kaniusas, Rosenow, Capone, Panetsos, Ackland, Kaithwas, O'Leary, Genheimer, Jacobs, Van Diest, Schoenen, Redgrave, Fang, Deuchars, Széles, Thayer, More, Vonck, Steenbergen, Vianna, McTeague, Ludwig, Veldhuizen, De Couck, Casazza, Keute, Bikson, Andreatta, D'Agostini, Weymar, Betts, Prigge, Kaess, Roden, Thai, Schuster, Montano, Hansen, Kroemer, Rong, Fischer, Howland, Sclocco, Sellaro, Garcia, Bauer, Gancheva, Stavrakis, Kampusch, Deuchars, Wehner, Laborde, Usichenko, Polak, Zaehle, Borges, Teckentrup, Jandackova, Napadow and Koenig.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

                History
                : 31 May 2020
                : 01 September 2020
                Page count
                Figures: 2, Tables: 3, Equations: 0, References: 312, Pages: 47, Words: 31397
                Categories
                Human Neuroscience
                Review

                Neurosciences
                transcutaneous vagus nerve stimulation,minimum reporting standards,guidelines & recommendations,transcutaneous auricular vagus nerve stimulation,transcutaneous cervical vagus nerve stimulation

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