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


Author: Adam D Farmer1, Adam Strzelczyk2, Alessandra Finisguerra3, Alexander V Gourine4, Alireza Gharabaghi5, Alkomiet Hasan6,7, Andreas M Burger8, Andrés M Jaramillo9, Ann Mertens10, Arshad Majid11, Bart Verkuil12, Bashar W Badran13, Carlos Ventura-Bort14, Charly Gaul15, Christian Beste16, Christopher M Warren17, Daniel S Quintana18,19,20, Dorothea Hämmerer21,22,23, Elena Freri24, Eleni Frangos25, Eleonora Tobaldini26,27, Eugenijus Kaniusas28,29, Felix Rosenow2, Fioravante Capone30, Fivos Panetsos31, Gareth L Ackland32, Gaurav Kaithwas33, Georgia H O'Leary13, Hannah Genheimer34, Heidi I L Jacobs35,36, Ilse Van Diest37, Jean Schoenen38, Jessica Redgrave11, Jiliang Fang39, Jim Deuchars40, Jozsef C Széles41, Julian F Thayer42, Kaushik More43,44, Kristl Vonck10, Laura Steenbergen45, Lauro C Vianna46, Lisa M McTeague13, Mareike Ludwig47, Maria G Veldhuizen48, Marijke De Couck49,50, Marina Casazza51, Marius Keute5, Marom Bikson52, Marta Andreatta34,53, Martina D'Agostini37, Mathias Weymar14,54, Matthew Betts47,55,56, Matthias Prigge44, Michael Kaess57,58, Michael Roden59,60,61, Michelle Thai62, Nathaniel M Schuster63, Nicola Montano26,27, Niels Hansen64,65, Nils B Kroemer66, Peijing Rong67, Rico Fischer68, Robert H Howland69, Roberta Sclocco70,71, Roberta Sellaro72,73,74, Ronald G Garcia75,76, Sebastian Bauer2, Sofiya Gancheva59,60,77, Stavros Stavrakis78, Stefan Kampusch28,29, Susan A Deuchars40, Sven Wehner79, Sylvain Laborde80, Taras Usichenko81,82, Thomas Polak83, Tino Zaehle84, Uirassu Borges80,85, Vanessa Teckentrup66, Vera K Jandackova86,87, Vitaly Napadow70,71, Julian Koenig57,88

Affiliation: <sup>1</sup> Department of Gastroenterology, University Hospitals of North Midlands NHS Trust, Stoke on Trent, United Kingdom.

<sup>2</sup> Department of Neurology, Epilepsy Center Frankfurt Rhine-Main, Goethe-University Frankfurt, Frankfurt am Main, Germany.

<sup>3</sup> Scientific Institute, IRCCS E. Medea, Pasian di Prato, Italy.

<sup>4</sup> Department of Neuroscience, Physiology and Pharmacology, Centre for Cardiovascular and Metabolic Neuroscience, University College London, London, United Kingdom.

<sup>5</sup> Institute for Neuromodulation and Neurotechnology, University Hospital and University of Tuebingen, Tuebingen, Germany.

<sup>6</sup> Department of Psychiatry, Psychotherapy and Psychosomatics, Medical Faculty, University of Augsburg, Augsburg, Germany.

<sup>7</sup> Department of Psychiatry and Psychotherapy, University Hospital, LMU Munich, Munich, Germany.

<sup>8</sup> Laboratory for Biological Psychology, Faculty of Psychology and Educational Sciences, University of Leuven, Leuven, Belgium.

<sup>9</sup> Leibniz Institute for Neurobiology, Magdeburg, Germany.

<sup>10</sup> Department of Neurology, Institute for Neuroscience, 4Brain, Ghent University Hospital, Gent, Belgium.

<sup>11</sup> Sheffield Institute for Translational Neuroscience (SITraN), University of Sheffield, Sheffield, United Kingdom.

<sup>12</sup> Clinical Psychology and the Leiden Institute of Brain and Cognition, Leiden University, Leiden, Netherlands.

<sup>13</sup> Department of Psychiatry, Medical University of South Carolina, Charleston, SC, United States.

<sup>14</sup> Department of Biological Psychology and Affective Science, Faculty of Human Sciences, University of Potsdam, Potsdam, Germany.

<sup>15</sup> Migraine and Headache Clinic Koenigstein, Königstein im Taunus, Germany.

<sup>16</sup> Cognitive Neurophysiology, Department of Child and Adolescent Psychiatry, Faculty of Medicine, TU Dresden, Dresden, Germany.

<sup>17</sup> Utah State University, Logan, UT, United States.

<sup>18</sup> NORMENT, Division of Mental Health and Addiction, University of Oslo and Oslo University Hospital, Oslo, Norway.

<sup>19</sup> Department of Psychology, University of Oslo, Oslo, Norway.

<sup>20</sup> KG Jebsen Centre for Neurodevelopmental Disorders, University of Oslo, Oslo, Norway.

<sup>21</sup> Medical Faculty, Institute of Cognitive Neurology and Dementia Research, Otto-von-Guericke University, Magdeburg, Germany.

<sup>22</sup> Institute of Cognitive Neuroscience, University College London, London, United Kingdom.

<sup>23</sup> Center for Behavioral Brain Sciences Magdeburg (CBBS), Otto-von-Guericke University, Magdeburg, Germany.

<sup>24</sup> Department of Pediatric Neuroscience, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy.

<sup>25</sup> Pain and Integrative Neuroscience Branch, National Center for Complementary and Integrative Health, NIH, Bethesda, MD, United States.

<sup>26</sup> Department of Internal Medicine, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milan, Italy.

<sup>27</sup> Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy.

<sup>28</sup> Institute of Electrodynamics, Microwave and Circuit Engineering, TU Wien, Vienna, Austria.

<sup>29</sup> SzeleSTIM GmbH, Vienna, Austria.

<sup>30</sup> Unit of Neurology, Neurophysiology, Neurobiology, Department of Medicine, Università Campus Bio-Medico di Roma, Rome, Italy.

<sup>31</sup> Faculty of Biology and Faculty of Optics, Complutense University of Madrid and Institute for Health Research, San Carlos Clinical Hospital (IdISSC), Madrid, Spain.

<sup>32</sup> Translational Medicine and Therapeutics, Barts and The London School of Medicine and Dentistry, William Harvey Research Institute, Queen Mary University of London, London, United Kingdom.

<sup>33</sup> Department of Pharmaceutical Sciences, School of Biosciences and Biotechnology, Babasaheb Bhimrao Ambedkar University (A Central University), Lucknow, India.

<sup>34</sup> Department of Biological Psychology, Clinical Psychology and Psychotherapy, University of Würzburg, Würzburg, Germany.

<sup>35</sup> Division of Nuclear Medicine and Molecular Imaging, Department of Radiology, Massachusetts General Hospital and Harvard Medical School, Boston, MA, United States.

<sup>36</sup> Faculty of Health, Medicine and Life Sciences, School for Mental Health and Neuroscience, Alzheimer Centre Limburg, Maastricht University, Maastricht, Netherlands.

<sup>37</sup> Research Group Health Psychology, Faculty of Psychology and Educational Sciences, University of Leuven, Leuven, Belgium.

<sup>38</sup> Headache Research Unit, Department of Neurology-Citadelle Hospital, University of Liège, Liège, Belgium.

<sup>39</sup> Functional Imaging Lab, Department of Radiology, Guang An Men Hospital, China Academy of Chinese Medical Sciences, Beijing, China.

<sup>40</sup> School of Biomedical Science, Faculty of Biological Science, University of Leeds, Leeds, United Kingdom.

<sup>41</sup> Division for Vascular Surgery, Department of Surgery, Medical University of Vienna, Vienna, Austria.

<sup>42</sup> Department of Psychological Science, University of California, Irvine, Irvine, CA, United States.

<sup>43</sup> Institute for Cognitive Neurology and Dementia Research, Otto-von-Guericke-University Magdeburg, Magdeburg, Germany.

<sup>44</sup> Neuromodulatory Networks, Leibniz Institute for Neurobiology, Magdeburg, Germany.

<sup>45</sup> Clinical and Cognitive Psychology and the Leiden Institute of Brain and Cognition, Leiden University, Leiden, Netherlands.

<sup>46</sup> NeuroV̇ASQ̇ - Integrative Physiology Laboratory, Faculty of Physical Education, University of Brasilia, Brasilia, Brazil.

<sup>47</sup> Department of Anatomy, Faculty of Medicine, Mersin University, Mersin, Turkey.

<sup>48</sup> Mental Health and Wellbeing Research Group, Vrije Universiteit Brussel, Brussels, Belgium.

<sup>49</sup> Faculty of Health Care, University College Odisee, Aalst, Belgium.

<sup>50</sup> Division of Epileptology, Fondazione IRCCS Istituto Neurologico C. Besta, Milan, Italy.

<sup>51</sup> Department of Neurosurgery, University of Tübingen, Tübingen, Germany.

<sup>52</sup> Department of Biomedical Engineering, City College of New York, New York, NY, United States.

<sup>53</sup> Department of Psychology, Education and Child Studies, Erasmus University Rotterdam, Rotterdam, Netherlands.

<sup>54</sup> Faculty of Health Sciences Brandenburg, University of Potsdam, Potsdam, Germany.

<sup>55</sup> Deutsches Zentrum für Neurodegenerative Erkrankungen (DZNE), Magdeburg, Germany.

<sup>56</sup> Center for Behavioral Brain Sciences, Otto-von-Guericke University, Magdeburg, Germany.

<sup>57</sup> University Hospital of Child and Adolescent Psychiatry and Psychotherapy, University of Bern, Bern, Switzerland.

<sup>58</sup> Section for Translational Psychobiology in Child and Adolescent Psychiatry, Department of Child and Adolescent Psychiatry, Centre for Psychosocial Medicine, University of Heidelberg, Heidelberg, Germany.

<sup>59</sup> Division of Endocrinology and Diabetology, Medical Faculty, Heinrich-Heine University Düsseldorf, Düsseldorf, Germany.

<sup>60</sup> Institute for Clinical Diabetology, German Diabetes Center, Leibniz Center for Diabetes Research at Heinrich Heine University, Düsseldorf, Germany.

<sup>61</sup> German Center for Diabetes Research, Munich, Germany.

<sup>62</sup> Department of Psychology, College of Liberal Arts, University of Minnesota, Minneapolis, MN, United States.

<sup>63</sup> Department of Anesthesiology, Center for Pain Medicine, University of California, San Diego Health System, La Jolla, CA, United States.

<sup>64</sup> Department of Psychiatry and Psychotherapy, University of Göttingen, Göttingen, Germany.

<sup>65</sup> Laboratory of Systems Neuroscience and Imaging in Psychiatry (SNIPLab), University of Göttingen, Göttingen, Germany.

<sup>66</sup> Department of Psychiatry and Psychotherapy, University of Tübingen, Tübingen, Germany.

<sup>67</sup> Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing, China.

<sup>68</sup> Department of Psychology, University of Greifswald, Greifswald, Germany.

<sup>69</sup> Department of Psychiatry, University of Pittsburgh School of Medicine, UPMC Western Psychiatric Hospital, Pittsburgh, PA, United States.

<sup>70</sup> Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Charlestown, MA, United States.

<sup>71</sup> Department of Radiology, Logan University, Chesterfield, MO, United States.

<sup>72</sup> Cognitive Psychology Unit, Institute of Psychology, Leiden University, Leiden, Netherlands.

<sup>73</sup> Leiden Institute for Brain and Cognition, Leiden, Netherlands.

<sup>74</sup> Department of Developmental Psychology and Socialisation, University of Padova, Padova, Italy.

<sup>75</sup> Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, United States.

<sup>76</sup> Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States.

<sup>77</sup> Heart Rhythm Institute, University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States.

<sup>78</sup> Faculty of Biological Science, School of Biomedical Science, University of Leeds, Leeds, United Kingdom.

<sup>79</sup> Department of Surgery, University Hospital Bonn, Bonn, Germany.

<sup>80</sup> Department of Performance Psychology, Institute of Psychology, Deutsche Sporthochschule, Köln, Germany.

<sup>81</sup> Department of Anesthesiology, University Medicine Greifswald, Greifswald, Germany.

<sup>82</sup> Department of Anesthesia, McMaster University, Hamilton, ON, Canada.

<sup>83</sup> Laboratory of Functional Neurovascular Diagnostics, AG Early Diagnosis of Dementia, Department of Psychiatry, Psychosomatics and Psychotherapy, University Clinic Würzburg, Würzburg, Germany.

<sup>84</sup> Department of Neurology, Otto-von-Guericke University, Magdeburg, Germany.

<sup>85</sup> Department of Social and Health Psychology, Institute of Psychology, Deutsche Sporthochschule, Köln, Germany.

<sup>86</sup> Department of Epidemiology and Public Health, Faculty of Medicine, University of Ostrava, Ostrava, Czechia.

<sup>87</sup> Department of Human Movement Studies, Faculty of Education, University of Ostrava, Ostrava, Czechia.

<sup>88</sup> Section for Experimental Child and Adolescent Psychiatry, Department of Child and Adolescent Psychiatry, Centre for Psychosocial Medicine, University of Heidelberg, Heidelberg, Germany.
Conference/Journal: Front Hum Neurosci
Date published: 2021 Mar 23
Other:
 Volume ID: 14   ,  Pages: 568051   ,  Special Notes: doi: 10.3389/fnhum.2020.568051.   ,  Word Count: 244  
    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.



Keywords: guidelines & recommendations; minimum reporting standards; transcutaneous auricular vagus nerve stimulation; transcutaneous cervical vagus nerve stimulation; transcutaneous vagus nerve stimulation.



PMID: 33854421 PMCID: PMC8040977 DOI: 10.3389/fnhum.2020.568051