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Статья
Guidelines for TMS/tES clinical services and research through the COVID-19 pandemic
2021
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. © 2020 The Authors
Цитирование
Похожие публикации
Версии
- 1. Version of Record от 2021-04-27
Метаданные
Название журнала
- Brain Stimulation
Том
- 13
Выпуск
- 4
Страницы
- 1124-1149
Ключевые слова
- adverse event; Article; behavioral addiction; biological monitoring; brain depth stimulation; cerebrovascular accident; checklist; clinical laboratory; clinical protocol; clinical research; cognition; cognitive therapy; comorbidity; conceptual framework; coronavirus disease 2019; epidemic; Florida; follow up; funding; hand washing; health care access; hospital; human; institutional review; instrument sterilization; managed care; mass screening; mental disease; mental health; mental health service; neurologic disease; neuromodulation; online analysis; pandemic; pediatrics; phase 3 clinical trial (topic); practice guideline; priority journal; regulatory mechanism; safety procedure; screening test; social distance; stroke patient; telemedicine; transcranial alternating current stimulation; transcranial direct current stimulation; transcranial electrical stimulation; transcranial magnetic stimulation; treatment indication; treatment response; videorecording; vulnerable population; addiction; aged; Betacoronavirus; brain; cerebrovascular accident; child; clinical trial (topic); Coronavirus infection; drug dependence; health care delivery; medical research; neurologic disease; physiology; practice guideline; procedures; transcranial magnetic stimulation; virus pneumonia; Aged; Behavior, Addictive; Betacoronavirus; Biomedical Research; Brain; Child; Clinical Trials as Topic; Coronavirus Infections; Delivery of Health Care; Humans; Nervous System Diseases; Pandemics; Pneumonia, Viral; Practice Guidelines as Topic; Stroke; Substance-Related Disorders; Telemedicine; Transcranial Direct Current Stimulation; Transcranial Magnetic Stimulation
Издатель
- Elsevier Inc.
Тип документа
- journal article
Тип лицензии Creative Commons
- CC
Правовой статус документа
- Свободная лицензия
Источник
- scopus
