Marom Bikson1, Colleen A Hanlon2, Adam J Woods3, Bernadette T Gillick4, Leigh Charvet5, Claus Lamm6, Graziella Madeo7, Adrienn Holczer8, Jorge Almeida9, Andrea Antal10, Mohammad Reza Ay11, Chris Baeken12, Daniel M Blumberger13, Salvatore Campanella14, Joan A Camprodon15, Lasse Christiansen16, Colleen Loo17, Jennifer T Crinion18, Paul Fitzgerald19, Luigi Gallimberti7, Peyman Ghobadi-Azbari20, Iman Ghodratitoostani21, Roland H Grabner22, Gesa Hartwigsen23, Akimasa Hirata24, Adam Kirton25, Helena Knotkova26, Evgeny Krupitsky27, Paola Marangolo28, Ester M Nakamura-Palacios29, Weronika Potok30, Samir K Praharaj31, Christian C Ruff32, Gottfried Schlaug33, Hartwig R Siebner34, Charlotte J Stagg35, Axel Thielscher36, Nicole Wenderoth30, Ti-Fei Yuan37, Xiaochu Zhang38, Hamed Ekhtiari39. 1. Department of Biomedical Engineering, The City College of New York of CUNY, New York, NY, USA. 2. Department of Cancer Biology, Wake Forest School of Medicine, Winston-Salem, NC, USA. 3. Center for Cognitive Aging and Memory, McKnight Brain Institute, Department of Clinical and Health Psychology, University of Florida, Gainesville, FL, USA. 4. Department of Rehabilitation Medicine, School of Medicine, University of Minnesota, MN, Minneapolis, USA. 5. Department of Neurology, NYU Grossman School of Medicine, New York, NY, USA. 6. Social, Cognitive and Affective Neuroscience Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Vienna, Austria. 7. Novella Fronda Foundation, Padua, Italy. 8. Department of Neurology, Albert Szent-Györgyi Health Center, Faculty of Medicine, University of Szeged, Hungary. 9. Proaction Lab, Faculty of Psychology and Educational Sciences, University of Coimbra, Portugal; CINEICC, Faculty of Psychology and Educational Sciences, University of Coimbra, Portugal. 10. Department of Clinical Neurophysiology, University Medical Center Göttingen, Göttingen, Germany; Institute of Medical Psychology, Otto-von-Guericke University Magdeburg, Magdeburg, Germany. 11. Department of Medical Physics and Biomedical Engineering, Tehran University of Medical Sciences, Tehran, Iran. 12. Faculty of Medicine and Health Sciences, Ghent Experimental Psychiatry (GHEP) Lab, Ghent University, Ghent, Belgium; Department of Psychiatry, University Hospital (UZBrussel), Brussels, Belgium; Department of Electrical Engineering, Eindhoven University of Technology, Eindhoven, the Netherlands. 13. Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, Canada; Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto, Canada. 14. Laboratoire de Psychologie Médicale et D'Addiction, ULB Neuroscience Institute (UNI), Université Libre de Bruxelles (ULB), Place Vangehuchten, B-1020, Brussels, Belgium. 15. Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA. 16. Danish Research Centre for Magnetic Resonance (DRCMR), Centre for Functional and Diagnostic Imaging and Research, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark. 17. School of Psychiatry & Black Dog Institute, University of New South Wales, Sydney, Australia. 18. Institute of Cognitive Neuroscience, University College London, London, UK. 19. Epworth Centre for Innovation in Mental Health, Epworth HealthCare and Department of Psychiatry, Monash University, Camberwell, Victoria, Australia. 20. Department of Biomedical Engineering, Shahed University, Tehran, Iran; Iranian National Center for Addiction Studies (INCAS), Tehran, Iran. 21. Neurocognitive Engineering Laboratory (NEL), Center for Mathematical Sciences Applied to Industry, Institute of Mathematical and Computer Sciences, University of Sao Paulo, Brazil. 22. Educational Neuroscience, Institute of Psychology, University of Graz, Austria. 23. Lise Meitner Research Group Cognition and Plasticity, Max Planck Institute for Human Cognitive and Brain Sciences, Leipzig, Germany. 24. Department of Electrical and Mechanical Engineering, Nagoya Institute of Technology, Nagoya, Japan. 25. Departments of Pediatrics and Clinical Neuroscience, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada. 26. MJHS Institute for Innovation in Palliative Care, New York, NY, USA; Department of Family and Social Medicine, Albert Einstein College of Medicine, The Bronx, NY, USA. 27. First Pavlov State Medical University, V. M. Bekhterev National Research Medical Center for Psychiatry and Neurology, St. Petersburg, Russia. 28. Department of Humanities Studies, University Federico II, Naples, Italy; Aphasia Research Lab, IRCCS Santa Lucia Foundation, Rome, Italy. 29. Department of Physiological Sciences, Federal University of Espírito Santo, Vitória, ES, Brazil. 30. Neural Control of Movement Lab, Department of Health Science and Technology, ETH Zurich, Switzerland. 31. Department of Psychiatry, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal, India. 32. Zurich Center for Neuroeconomics (ZNE), Department of Economics, University of Zurich, Zurich, Switzerland. 33. Neuroimaging-Neuromodulation and Stroke Recovery Laboratory, Department of Neurology, Beth Israel Deaconess Medical Center and Baystate Medical Center, UMass Medical School, MA, USA. 34. Danish Research Centre for Magnetic Resonance (DRCMR), Centre for Functional and Diagnostic Imaging and Research, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark; Institute of Clinical Medicine, Faculty of Health Sciences and Medicine, University of Copenhagen, Copenhagen, Denmark. 35. Wellcome Centre for Integrative Neuroimaging and MRC Brain Network Dynamics Unit, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK. 36. Danish Research Centre for Magnetic Resonance (DRCMR), Centre for Functional and Diagnostic Imaging and Research, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark; Department of Health Technology, Technical University of Denmark, Kgs. Lyngby, Denmark. 37. Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai, China. 38. CAS Key Laboratory of Brain Function and Disease and School of Life Sciences, Division of Life Science and Medicine, University of Science & Technology of China, Hefei, China. 39. Laureate Institute for Brain Research, Tulsa, OK, USA. Electronic address: hekhtiari@laureateinstitute.org.
Abstract
BACKGROUND: The COVID-19 pandemic has broadly disrupted biomedical treatment and research including non-invasive brain stimulation (NIBS). Moreover, the rapid onset of societal disruption and evolving regulatory restrictions may not have allowed for systematic planning of how clinical and research work may continue throughout the pandemic or be restarted as restrictions are abated. The urgency to provide and develop NIBS as an intervention for diverse neurological and mental health indications, and as a catalyst of fundamental brain research, is not dampened by the parallel efforts to address the most life-threatening aspects of COVID-19; rather in many cases the need for NIBS is heightened including the potential to mitigate mental health consequences related to COVID-19. OBJECTIVE: To facilitate the re-establishment of access to NIBS clinical services and research operations during the current COVID-19 pandemic and possible future outbreaks, we develop and discuss a framework for balancing the importance of NIBS operations with safety considerations, while addressing the needs of all stakeholders. We focus on Transcranial Magnetic Stimulation (TMS) and low intensity transcranial Electrical Stimulation (tES) - including transcranial Direct Current Stimulation (tDCS) and transcranial Alternating Current Stimulation (tACS). METHODS: The present consensus paper provides guidelines and good practices for managing and reopening NIBS clinics and laboratories through the immediate and ongoing stages of COVID-19. The document reflects the analysis of experts with domain-relevant expertise spanning NIBS technology, clinical services, and basic and clinical research - with an international perspective. We outline regulatory aspects, human resources, NIBS optimization, as well as accommodations for specific demographics. RESULTS: A model based on three phases (early COVID-19 impact, current practices, and future preparation) with an 11-step checklist (spanning removing or streamlining in-person protocols, incorporating telemedicine, and addressing COVID-19-associated adverse events) is proposed. Recommendations on implementing social distancing and sterilization of NIBS related equipment, specific considerations of COVID-19 positive populations including mental health comorbidities, as well as considerations regarding regulatory and human resource in the era of COVID-19 are outlined. We discuss COVID-19 considerations specifically for clinical (sub-)populations including pediatric, stroke, addiction, and the elderly. Numerous case-examples across the world are described. CONCLUSION: There is an evident, and in cases urgent, need to maintain NIBS operations through the COVID-19 pandemic, including anticipating future pandemic waves and addressing effects of COVID-19 on brain and mind. The proposed robust and structured strategy aims to address the current and anticipated future challenges while maintaining scientific rigor and managing risk.
BACKGROUND: The COVID-19 pandemic has broadly disrupted biomedical treatment and research including non-invasive brain stimulation (NIBS). Moreover, the rapid onset of societal disruption and evolving regulatory restrictions may not have allowed for systematic planning of how clinical and research work may continue throughout the pandemic or be restarted as restrictions are abated. The urgency to provide and develop NIBS as an intervention for diverse neurological and mental health indications, and as a catalyst of fundamental brain research, is not dampened by the parallel efforts to address the most life-threatening aspects of COVID-19; rather in many cases the need for NIBS is heightened including the potential to mitigate mental health consequences related to COVID-19. OBJECTIVE: To facilitate the re-establishment of access to NIBS clinical services and research operations during the current COVID-19 pandemic and possible future outbreaks, we develop and discuss a framework for balancing the importance of NIBS operations with safety considerations, while addressing the needs of all stakeholders. We focus on Transcranial Magnetic Stimulation (TMS) and low intensity transcranial Electrical Stimulation (tES) - including transcranial Direct Current Stimulation (tDCS) and transcranial Alternating Current Stimulation (tACS). METHODS: The present consensus paper provides guidelines and good practices for managing and reopening NIBS clinics and laboratories through the immediate and ongoing stages of COVID-19. The document reflects the analysis of experts with domain-relevant expertise spanning NIBS technology, clinical services, and basic and clinical research - with an international perspective. We outline regulatory aspects, human resources, NIBS optimization, as well as accommodations for specific demographics. RESULTS: A model based on three phases (early COVID-19 impact, current practices, and future preparation) with an 11-step checklist (spanning removing or streamlining in-person protocols, incorporating telemedicine, and addressing COVID-19-associated adverse events) is proposed. Recommendations on implementing social distancing and sterilization of NIBS related equipment, specific considerations of COVID-19 positive populations including mental health comorbidities, as well as considerations regarding regulatory and human resource in the era of COVID-19 are outlined. We discuss COVID-19 considerations specifically for clinical (sub-)populations including pediatric, stroke, addiction, and the elderly. Numerous case-examples across the world are described. CONCLUSION: There is an evident, and in cases urgent, need to maintain NIBS operations through the COVID-19 pandemic, including anticipating future pandemic waves and addressing effects of COVID-19 on brain and mind. The proposed robust and structured strategy aims to address the current and anticipated future challenges while maintaining scientific rigor and managing risk.
Keywords:
COVID-19; Non-invasive brain stimulation; Transcranial alternating current stimulation; Transcranial direct current stimulation; Transcranial electrical stimulation; Transcranial magnetic stimulation
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