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.

中文翻译：

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COVID-19 大流行期间的 TMS/tES 临床服务和研究指南

摘要背景 COVID-19 大流行已广泛扰乱了包括非侵入性脑刺激 (NIBS) 在内的生物医学治疗和研究。此外，社会动荡的迅速发生和不断变化的监管限制可能无法系统地规划临床和研究工作如何在整个大流行期间继续进行，或随着限制的减弱而重新启动。提供和开发 NIBS 作为对各种神经和心理健康适应症的干预以及作为基础大脑研究的催化剂的紧迫性并没有因为解决 COVID-19 最危及生命的方面的并行努力而减弱；相反，在许多情况下，对 NIBS 的需求增加了，包括减轻与 COVID-19 相关的心理健康后果的潜力。目标 为了促进在当前 COVID-19 大流行和未来可能爆发的期间重新获得 NIBS 临床服务和研究操作，我们制定并讨论了一个框架，以平衡 NIBS 操作的重要性与安全考虑，同时满足所有利益相关者。我们专注于经颅磁刺激 (TMS) 和低强度经颅电刺激 (tES) - 包括经颅直流电刺激 (tDCS) 和经颅交流电刺激 (tACS)。方法 本共识文件提供了在 COVID-19 的当前和持续阶段管理和重新开放 NIBS 诊所和实验室的指南和良好实践。该文件反映了具有跨越 NIBS 技术的领域相关专业知识的专家的分析，具有国际视野的临床服务、基础和临床研究。我们概述了监管方面、人力资源、NIBS 优化以及针对特定人口统计的调整。结果 基于三个阶段（早期 COVID-19 影响、当前实践和未来准备）的模型，包含 11 步检查表（包括删除或简化面对面协议、结合远程医疗和解决 COVID-19 相关的不良事件）被提议。概述了对 NIBS 相关设备实施社交距离和消毒的建议、对 COVID-19 阳性人群（包括心理健康合并症）的具体考虑，以及 COVID-19 时代有关监管和人力资源的考虑。我们专门针对临床（亚）人群（包括儿科、中风、成瘾和老年人）讨论 COVID-19 的注意事项。描述了世界各地的许多案例。结论 在 COVID-19 大流行期间，显然需要在紧急情况下维持 NIBS 运营，包括预测未来的大流行浪潮和解决 COVID-19 对大脑和精神的影响。拟议的稳健和结构化战略旨在解决当前和预期的未来挑战，同时保持科学严谨性和管理风险。包括预测未来的大流行浪潮和解决 COVID-19 对大脑和思维的影响。拟议的稳健和结构化战略旨在解决当前和预期的未来挑战，同时保持科学严谨性和管理风险。包括预测未来的大流行浪潮和解决 COVID-19 对大脑和思维的影响。拟议的稳健和结构化战略旨在解决当前和预期的未来挑战，同时保持科学严谨性和管理风险。