Guidelines for TMS/tES clinical services and research through the COVID-19 pandemic.

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.

Informations de copyright

Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of competing interest Marom Bikson has equity on Soterix Medical, is consultant or SAB of Boston Scientific, GSK, Halo Neuroscience, GSK, X and is inventor of brain stimulation patents and has grant support from NIH (MH111896, NS101362, NS112996). Colleen A. Hanlon has served as a consultant for Brainsway and receives grant support from the NIH (R01DA036617, R01DA044471, R01AA027705, R21DA044503). Adam J. Woods is a member of the scientific advisory board for Halo Neuroscience and has grant support from NIH (R01AG054077, R01AG064587, K01AG050707, R21MH112206, R37AG033906, RF1MH114290). Bernadette T. Gillick reports no conflict of interest and has current grant support from the NIH (R21HD097575), the National Center of Neuromodulation for Rehabilitation, and the Shepherd Trust/Jensen Family Award. Leigh Charvet has no conflict of interest and has current grant support from the NIH (R21NS101712), US Department of Defense (W81XWH-17-1-0320), National Multiple Sclerosis Society (RG-1803-30492) and the Lourie Foundation Inc. Adrienn Holczer reports no conflict of interest and is supported by the grant EFOP 3.6.3-VEKOP-16-2017-00009. Jorge Almeida has no conflict of interest and is supported by an ERC Starting Grant (Grant # 802553 - “ContentMAP”), and by grant PTDC/MHC-PCN/6805/2014 from Fundação para a Ciência e a Tecnologia Portugal, and Programa COMPETE. Andrea Antal has received honoraria as speaker from NeuroCare (Munich, Germany) and as consultant from Savir GmbH (Magdeburg, Germany). Daniel M. Blumberger has received research support from Canadian Institutes for Health Research, National Institutes Health (US), Brain Canada and the Temerty Family through the CAMH Foundation and the Campbell Family Research Institute. He received research support and in-kind equipment support for an investigator-initiated study from Brainsway Ltd. He is the site principal investigator for three sponsor-initiated studies for Brainsway Ltd. He also receives in-kind equipment support from Magventure for investigator-initiated research. He received medication supplies for an investigator-initiated trial from Indivior. Joan A. Camprodon is a scientific advisor for Apex Neuroscience, has received royalties as book editor from Springer and has grant support from NIH (RO1 MH112737, R21 DA042271, R21 AG056958 and R21 MH115280). Colleen Loo has received royalties as book editor from Springer and has grant support from the Australian National Health and Medical Research Council. Jenny Crinion declares no conflict of interest and is supported by a Wellcome Trust Senior Research Fellowship in Clinical Science (106161/Z/14/Z). For this research as a part of Multidisciplinary Cognitive Rehabilitation (MCR) Platform, Iman Ghodratitoostani was supported (Grant number: 2013/07375-0) by Innovation and Diffusion of Mathematical Sciences Center Applied to Industry (CEPID-CeMEAI) of Sao Paulo Research Foundation (FAPESP), the University of Sao Paulo. Roland H. Grabner reports no conflict of interest and is supported by the Austrian Science Fund FWF (Grant P30050). Christian Ruff reports no conflict of interest and was supported by grants from the Swiss National Science Foundation SNSF (grant no. 100019L_173248) and from the European Research Council (ERC) under the European Union’s Horizon 2020 research and innovation programme (grant agreement No 725355, ERC Consolidator BRAINCODES). Gottfried Schlaug has no conflict of interest and acknowledges support from the NIH (R01MH111874, U01NS102353). Hartwig R. Siebner has received honoraria as speaker from Sanofi Genzyme, Denmark and Novartis, Denmark, as consultant from Sanofi Genzyme, Denmark and as editor-in-chief (Neuroimage Clinical) and senior editor (NeuroImage) from Elsevier Publishers, Amsterdam, The Netherlands. He has received royalties as book editor from Springer Publishers, Stuttgart, Germany and from Gyldendal Publishers, Copenhagen, Denmark. Hartwig R. Siebner holds a 5-year professorship in precision medicine at the Faculty of Health Sciences and Medicine, University of Copenhagen which is sponsored by the Lundbeck Foundation (Grant Nr. R186-2015-2138). Xiaochu Zhang reports no conflict of interest and is supported by The National Key Basic Research Program (2016YFA0400900 and 2018YFC0831101), The National Natural Science Foundation of China (71942003, 31771221, 61773360, and 71874170). Hamed Ekhtiari reported no conflict of interest and is supported by grants from Brain and Behavior Foundation (NARSAD Young Investigator Award #27305) and Warren K. Family Foundation. Claus Lamm, Graziella Madeo, Mohammad Reza Ay, Chris Baeken, Salvatore Campanella, Lasse Christiansen, Paul Fitzgerald, Luigi Gallimberti, Peyman Ghobadi-Azbari, Gesa Hartwigsen, Akimasa Hirata, Adam Kirton, Helena Knotkova, Evgeny Krupitsky, Paola Marangolo, Ester M. Nakamura-Palacios, Weronika Potok, Samir K. Praharaj, Charlotte J. Stagg, Axel Thielscher, Nicole Wenderoth, and Ti-Fei Yuan report no conflict of interest or specific funding for this work.