key: cord-0812951-6wlq7syf
authors: Bikson, Marom; Hanlon, Colleen A.; Woods, Adam J.; Gillick, Bernadette T.; Charvet, Leigh; Lamm, Claus; Madeo, Graziella; Holczer, Adrienn; Almeida, Jorge; Antal, Andrea; Ay, Mohammad Reza; Baeken, Chris; Blumberger, Daniel M.; Campanella, Salvatore; Camprodon, Joan; Christiansen, Lasse; Colleen, Loo; Crinion, Jenny; Fitzgerald, Paul; Gallimberti, Luigi; Ghobadi-Azbari, Peyman; Ghodratitoostani, Iman; Grabner, Roland; Hartwigsen, Gesa; Hirata, Akimasa; Kirton, Adam; Knotkova, Helena; Krupitsky, Evgeny; Marangolo, Paola; Nakamura-Palacios, Ester M.; Potok, Weronika; Praharaj, Samir K.; Ruff, Christian C.; Schlaug, Gottfried; Siebner, Hartwig R.; Stagg, Charlotte J.; Thielscher, Axel; Wenderoth, Nicole; Yuan, Ti-Fei; Zhang, Xiaochu; Ekhtiari, Hamed
title: Guidelines for TMS/tES Clinical Services and Research through the COVID-19 Pandemic
date: 2020-05-12
journal: Brain Stimul
DOI: 10.1016/j.brs.2020.05.010
sha: ffe9ca8d06f53d3b2c6ab8cc9bb56f8ec7e47506
doc_id: 812951
cord_uid: 6wlq7syf

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.

COVID-19 was first recognized in December 2019 and within months evolved into a global 141 pandemic declared by the World Health Organization (WHO) in March 2020. To avert its rapid 142 spread, country-specific restrictions have been introduced spanning strict social/physical 143 distancing measures, stay-at-home orders and even lockdowns, workplace closings and 144 furloughs/layoffs, postponing of elective procedures in medical centers to preserve medical 145 resources, suspending many in-person medical consultation and clinic visits, or substituting 146 these face to face consultations with remote interventions, e.g. telecommunications. Measures 147 to limit person-to-person contact affected institutions and researchers applying non-invasive 148 brain stimulation (NIBS) operations. With the suddenness of COVID-19 emergence, operations 149 at clinics and research centers administering NIBS were disrupted to varied degrees -from 150 suspension of all activities, to limiting new enrollment or abbreviation protocols, to incremental 151 accommodations -depending on regional restrictions and the nature of underling protocols (e.g. 152

in-person treatment vs remote treatment). The means of maintaining (and even expanding) 153 access to NIBS during the COVID-19 pandemic are strategically evolving. Considering that 154 NIBS is a unique non-pharmacological tool, forms of which have been successfully established 155 for treatment of a wide range of neurological and psychiatric disorders [1] [2] [3] [4] [5] [6] [7] , often on 156 moderately or even severely impaired patients unresponsive to conventional therapies [8, 9] During the COVID-19-related stay-at-home mandate, critical consideration must be given to re-354 integration strategies and approaches for restarting studies and trials. The timing and details of 355 re-integration procedures will vary significantly across institutions, as did study stoppage and 356 stay-at-home procedures. Nonetheless, brain stimulation teams can begin planning for potential 357 iterations of re-integration procedures. At present, commonly discussed strategies across 358 institutions include a tiered return to institutions for study teams, potential split shifts for study 359 team members to cover study activities, PPE for all participants and study staff, COVID-19 360 infection or antibody testing procedures, body temperature assessment of all staff and 361 participants, redesign of lab procedures/space to minimize person-to-person contact, new 362 facility and equipment sanitization procedures, among others (see also below, section 6). While 363 institutional procedures will vary, advanced planning for how these procedures will impact study 364 continuation is important. In addition, study teams will be faced with a backlog of participants 365 that either missed planned follow-up visits or have upcoming follow-up visits, as well as a need 366 to replace participants whose intervention schedules were interrupted by stay-at-home 367 mandates. Study teams will likely be strained to perform all needed activities for study 368 continuation upon return. Advanced planning for prioritization of study activities will be important 369 for efficient transition back to in-person activity. We are also faced with the uncertain possibility of one or more recurrent waves of COVID-19 373 and similar epidemic/pandemic outbreaks in the coming months and years. Thus, careful consideration of protective equipment to protect research participants and staff members, to 375 disinfect tools and labs, and long-term planning for implementation of remote assessment 376 and/or intervention procedures may prove critical for long-term continuation of studies should 377 this become a reality. Further still, once rapid COVID-19 testing and antibody assays are proven 378 to be reliable and widely available, we will have tools that may allow us to alter how we respond 379 to future waves of COVID-19. If procedures for maximizing the safety of in-person study 380 activities (modification of space for face to face visits, restructuring of waiting areas to separate 381 participants/patients, stringent PPE procedures, etc.) can be implemented immediately following 382 the current outbreak, these methods paired with new COVID-19 testing procedures may 383 redefine how we respond to future COVID-19 pandemic events. For example, most TMS clinics 384 around the world were shut down for depression treatment following the initial COVID-19 385 outbreak, preventing access to care needed by patients. If careful in our current and future 386 response, different approaches for safely continuing such activities may be possible. We can 387 consider developing institution specific standard operating procedures for the labs and 388 orientation of all staff members to deal with future outbreaks. As such, we provide a summary of 389 important considerations for response to COVID-19 as well as a checklist for adapting research 390 and treatment practices to COVID-19 in Table 3 . 391

Insert Table 3 about here  393   394 

Here we provide a list of recommendations for adapting research and treatment practices to 397 COVID-19 pandemic. 398 399 1) Conduct a systematic updated risk-benefit analysis of each protocol to decide for 400 each effort if it should continue and inform remaining steps; this may include 401 contingency plans to changes in a given circumstance (e.g. if X happens the trial will 402 need to wind down under these conditions), engaging all stakeholders in discussion 403 (e.g. staff, program office, DSMB, etc.), and statistical consultation with respect to the 404 power to make conclusions regarding protocol changes (e.g. change in dose, trials 405 terminated prematurely) and associated changes in outcome reporting (e.g. feasibility 406 instead of efficacy). 407 no way encouraging a decrease in the standards required for publication. Rather, an increase in 511 understanding around the circumstances in which that work is done is called for. 512 513 Firstly, it is vital to recognize the additional anxiety the current situation will place on Early 514

Career Researchers and PhD students. For students with only months of funding left with which 515 to complete their degrees, this is a very stressful time, as it is for those more senior researchers 516 with grant deadlines. It is to be hoped that this paper will provide helpful suggestions and 517 contribute to the discussion for ways to ease the difficulties faced at this time, however, the 518 inevitable anxieties associated with the current situation are real and should be explicitly 519 acknowledged. We must work to address these and to support our colleagues through this 520 difficult time. 521 522 Research groups around the world will be physically separate, indeed often spread across time 523 zones if students choose to spend this unprecedented period at home. This will inevitably lead 524 to psychological stress, something that has already been seen in China [13] . Maintaining group 525 cohesion is vital and implementing explicit support structures is necessary, particularly for those 526

isolating on their own with families elsewhere [14] . While online tools cannot replace face-to-527 face interactions, they are vital substitutes in current times. The vast majority of labs will have 528 moved work meetings online already, but in addition to these it is important to recognize that for 529 many work is also a social experience and now more than ever, an essential source of support. 530

Scheduled coffee breaks, games nights, film nights, cocktail hours (with alcoholic or non-531 alcoholic drink of choice) and many other social events are all being implemented successfully 532 across the world to create at least some of the social interactions so important to both our 533 mental wellbeing and our lab cohesion. Explicitly matching group members in a buddy-scheme, 534

where each lab member has a partner that they have to contact even briefly each day, is a way 535 of providing a light touch method to flag potential mental health issues early. While we cannot 536 prevent the inevitable increased rates of mental health problems in our community, making sure 537 that we explicitly discuss the difficulties we all face in this pandemic, and the inevitable mental 538 health repercussions, will hopefully allow those facing particular problems to speak out and 539 receive the support they need [15] . 540 541 It is necessary to act now to ensure that the current pandemic does not have long-lasting 542 negative consequences on the field. NIBS has historically had a lack of female representation 543

[16], something that leaders in the field have made a concerted effort to address in recent years [17] with increasing success. However, the current crisis is likely to exacerbate the gap between 545 women and men, and between carers and non-carers, in terms of available time and 546 opportunities. The burden of care and responsibilities have fallen unequally in this crisis -for 547 some this is a virtually unheard of period of quiet in which they have the time to produce as 548 much, if not more, work than normal. However, for the field as a whole it is vital to recognize that 549 for others this is a time where demands and anxieties have increased, and available time has 550 shrunk considerably. The "room of one's own in which to write" [18] is for some a daily reality 551 and for others merely a distant dream. The real effects of this inequality across academia is 552 already being spoken about anecdotally by editors, who report decreases in the number of 553 submissions from women [19] and, possibly, increases in the number of submissions from men. 554

How those trends continue will need to be carefully monitored. 555

While it is extremely difficult to judge what effect other responsibilities may have on our 557 colleague's productivity, it is timely to recognize that although individual circumstances vary 558 substantially on average women still carry the majority of the burden of both caring 559 responsibilities and household tasks even when both partners work [20] -something that can at 560 the moment only exacerbate gender imbalances in the field. It must therefore, be the 561 responsibility of all of us, particularly those in more senior positions, to acknowledge this and to 562 challenge the potential prejudices of others and ourselves when making career-determining 563 decisions, not just at the moment but in the months and years to come. Suggestions have 564 already been made as to ways to tackle this, including explicitly treating this period as carers 565 leave in future applications [21] . 566 567 In the shorter term, the social/physical distancing measures in place around the world are not 568 only limiting what we can do in terms of science, but limiting the opportunities for all of us, 569 particularly the Early Career Researchers, to network and to meet potential advisors for the next 570 stage of their careers. Initiatives such as on-line conferences are likely going to be the 571 mechanism for sharing our science for at least the next few months and provide an essential 572 opportunity for our ECRs to discuss their work. However, what is difficult to reproduce on-line is 573 the informal chat over coffee with others in the field, which can often provide the start to a 574 conversation that ends with a postdoctoral position or support for tenure-track applications. 575

Overcoming these restrictions will be difficult: by definition it is challenging to formally engineer 577 informal discussions. We all have a responsibility to recognize this, and to be responsive to 578 unsolicited emails from researchers elsewhere. This is also a time to embrace the ability to 579 invite speakers from around the world to give informal talks at lab meetings and small 580 gatherings without the costs involved in travel. Not only does this broaden our horizons at a time 581

when it is all too easy to reduce our interactions, it also has secondary benefits. Small lab talks 582 provide excellent opportunity to interact with external researchers in a small group. Inviting 583 senior researchers to speak can provide a route into discussions for ECRs, inviting ECRs to 584 speak provides valuable experience for them. 585

In practical terms, many universities have relaxed the timescales required for PhD students, 587 something that we must support and petition for. Many grant bodies around the world have 588 already announced blanket extensions to current funding -as a field it is our responsibility to 589 make these allowances as equitable as possible. A number of routes through the current crisis 590 have been suggested in the rest of this article which will allow us to continue our research with 591 disruption kept to a minimum. However, in the inevitable rush back to the lab, for the long-term 592 sake of the field we must not forget to bring everyone with us. 593 594

As with all COVID-19 safety procedures, regional and institutional guidances, applied judiciously 596 to specific protocols considering changing conditions, will determine which procedures should 597 be implemented and which can be abbreviated. Our recommendations below explain a range of 598 existing procedures in the context of NIBS application and should not be considered necessary 599 or sufficient for every situation. 600 601

A critical factor in controlling and reducing the spread of SARS-CoV-2 and the associated 603 COVID-19 has been so-called social/physical distancing, which means preventing physical 604 contact especially of persons who otherwise would not have social contact. What is essential to 605 understand here is that the terminology "social/physical distancing" may be somewhat 606

misleading, as what matters in essence is the physical distancing. The latter in turn has mainly 607 been recommended because one dominant way by which SARS-CoV-2 is transmitted is by 608 airborne droplet infection. More specifically, aerosols emanating from the upper respiratory 609 pathway housing the virus in high concentrations are thought to passively "travel" through the air 610 and remain airborne for some time. While the exact travel distance and the amount of time that 611 infectious materials maintain in the air are currently a matter of debate, most recommendations suggest keeping (at least) 2 m (6 ft) distance to any other person and assuming that any 613 unknown person could potentially be infectious [22] . Minimizing duration of contact is another 614 strategy that may be considered based on study protocols, current federal and institutional 615 guidances, and current scientific consensus on impact of briefer contact times (protocols) in 616 reducing risk to operators and patients. 617 618 Social/Physical distancing parameters as defined by governments and regulatory authorities 619 vary among countries, states and counties and change over time as a regional Covid-19 620 situation develops. The following procedures are therefore region and institute specific, and 621 subject to ongoing risk-burden evaluation. As applicable, social distancing should be maintained 622 in all offices. The allowed density of staff in given rooms should be considered along with the 623 need for and mechanism of minimizing face-to-face interaction (e.g. by using chat, emails or 624 telephones). As applicable to the specific time and protocol, it may be prudent to wear masks 625 and maintain a recommended interpersonal distance. If and when patients should wear masks 626 for necessary clinical treatments should be determined. For studies and therapies where 627 wearing masks hinders the efficacy, transparent face masks could be considered. 628

During NIBS procedures, it is often not possible to maintain the recommended physical 629 distance, at least for some amount of time. For instance, applying electrodes for tES or 630 adjusting the position of TMS coils requires direct contact between the person applying NIBS 631 and the person receiving NIBS. Robotic TMS provides some opportunity for TMS administration 632 with operators further removed from participants (easily by 2 meters/ 6 feet except for brief 633 localization to navigation, though the participant can be trained to do this). However, such 634 devices will not be available to all labs and clinics. In these instances, protective measures are 635 important to reduce the inhalation and expiration of aerosols, and the amount of time, during 636 which the recommended physical distance cannot be complied with, should be restricted to a 637 minimum possible. 638 639 6.2 Personal Protective Equipment (PPE) 640 PPE can take many forms such as wearing face masks that should cover both mouth and nose. 641

There are different safety standards for these masks, and we recommend that medical and 642 research personnel in constant contact with potentially infected persons (including participants 643 and patients, but also co-workers) wear those with the highest safety standards (e.g. N95 644 masks). Importantly, the masks should be regularly changed (with maximal wear time differing 645 as per the specific type and make of the mask) as otherwise they might even be 646 counterproductive due to the accumulation of viral material at the inner side of the mask. If 647 appropriate, patients and participants may be provided with single use or disinfected multiple 648 use masks by the neuromodulation labs. 649 650 As appropriate, in addition to masks, medical and research personnel may consider wearing 651 transparent visors, or protective eye wear covering the upper parts of the face and especially 652 the eyes, through which viral material can also easily enter the organism. Visors that cover the 653 whole front of the face extending way down below the chin may supplement face masks for 654 researchers and participants. In theory, the appeal of visors without masks is allowing better 655 verbal communication, compared to face masks, which limit articulation and comprehensibility of 656 speech sounds i.e., the "muffling" effect-b but such considerations are secondary to safety. The 657 appropriateness of visors and other PPE (e.g. goggles, protective coats) in various social and 658 clinical environments will ultimately depend on current regional and institutional guidances. In 659 some regions and institutions, current recommendations are to use both a surgical mask and 660 visor for direct interactions with patients. 661 662 Moreover, medical and research personnel should wear single use gloves when touching 663 participants and patients, and the latter may also want to be provided with such gloves when 664 touching apparel that will be touched by others, such as input devices, computer keyboards, 665 desks, etc. 666 667

As with all COVID-19 safety procedures, regional and institutional guidances, applied judiciously 669 to specific protocols considering changing conditions, will determine which procedures should 670 be implemented and which can be abbreviated. Our recommendations here thus index possible 671 applicable procedures. 672 673 Besides body-worn protective measures, room dividers and transparent shields can be 674 considered for installation in facilities that are not already designed for one-on-one visits. These 675 devices constitute a physical barrier protecting spread of aerosols throughout the room from 676 participants and patients to personnel and will be especially important at patient receptions. 677

Provisions of hand washing opportunities, or hand sanitizers for patients and participants at the 678 entrance to research and treatment premises are also generally recommended, and they should 679 be provided in a way that they can be regularly and easily used by medical and research personnel, after each new contact with a new person. Additional measures to minimize airborne 681 particles being transmitted are regular ventilation of research and treatment laboratories, regular 682 disinfection of surfaces, such as doorknobs, apparel, furniture, research equipment and visors 683 as well as shields, ideally after each use by a new person, is highly recommended. Within 684 elevators, covering all buttons with plastic membranes that are changed daily is advised. Tissue 685 paper or small wooden pieces can be provided to push the button without skin contact. 686 687 Special consideration should be given for employing single-use equipment when possible. For 688 example, within tES, a variety of single-use and multi-use electrodes is available. Maximizing 689 the use of single-use devices that contact the participant/patient serves to minimize potential 690 translocation of virally active material from one participant to the other. Where devices must be 691 used across participants, antibacterial disinfection may not be sufficient. In all cases, all 692 research equipment should be sanitized/disinfected before and after use. In this, special 693 consideration as to which type of disinfectant is used needs to be applied, as the functionality of 694 some electrodes may be negatively affected when disinfected with alcohol-based disinfectants. 695

One potential alternative to alcohol-based disinfectants is the use of Hydrogen Peroxide. We 696 recommend referring to manufacturer information to evaluate possible disinfection routines. All 697 disposable supplies should be discarded in appropriate bio-waste repositories. Note that most of 698 the considerations regarding sanitization protocols should not only be applied to laboratories 699 and treatment facilities, but also for the off-site home use mentioned above in this paper. 700

The following disinfection and sanitization protocols are aiming to give research facilities some 701 flexibility to re-start NIBS clinical services and research operations during the current COVID-19 702 pandemic and possibly similar outbreaks in the future for patients with non-COVID-19 needs or 703 complex chronic disease management requirements. 704

• After the NIBS session is over, the environmental surfaces in the stimulation 705 room should be sanitized using a 1% Hypochlorite solution, with a disposable 706 antiseptic cloth [23] . Also, all the stimulation equipment, including magnetic coil 707 (for TMS) stimulator, electrode/stimulator cables, EEG cap, tape measure, 708 electrodes and sponge pockets should be sanitized. Follow manufacturer specific 709 guidance on how to clean the stimulator. Furthermore, it is prudent to check for 710 any leaked fluids from the participant on the stimulation chair. 711

• The stimulator trolley and treatment chair should be wiped with a permitted 712 cleaning product (normally bacillocid is allowed, but it is better to check with the 713 manufacturer). 714

• If an MRI/MEG-compatible stimulator is available for concurrent application of 715 NIBS during the recording of neuroimaging or electrophysiological data, then the 716 gantry and the RF coil should be sanitized with a permitted cleaning product. The 717 MRI table also should be sanitized with any of the approved products. The coils 718 need to be disinfected once again after the scanner room is thoroughly sanitized, 719 then the next patient or participant may be taken [24] . It is necessary to ensure 720 that the metal nose piece of surgical masks, if applicable, is not ferromagnetic 721

[25]. 722 723

An additional aspect that requires consideration is the inclusion of individuals that belong to 725 high(er) risks groups, both on the side of the personnel and the research participants or 726 patients. Currently, older age, a history of cardiovascular diseases and diseases affecting the 727 respiratory system (e.g. asthma, smoking), but also diabetes, obesity and cancer or other 728 diseases affecting the immune system directly or through immuno-depressant treatment (e.g. On a critical note, many of these measures are not based on concrete evidence on their 744 effectiveness. There is still insufficient knowledge about which of them are necessary and 745 sufficient to prevent further spread of the virus. However, to the best of our current knowledge, 746 they can be expressed as strongly recommended. Another critical aspect is whether the 747 measures can be implemented consistently. In many countries, for instance, masks but even 748 disinfectants are still not available in the required quantities and using the limited number of 749 protective measures for protection of healthcare workers treating COVID-19 patients should be 750 given higher priority than using it for neuromodulation research. checklist, which every person entering the research or treatment premises has to provide, as 756 well as by temperature measurements at the entrance to the research facilities. All of the latter, 757 however, may be of limited validity, as many persons infected by SARS-CoV-2 have been 758 reported to be asymptomatic, and do not develop the associated disease (and thus will neither 759 show symptoms, including fever). Many institutions have plans to implement either rapid 760 COVID-19 testing and/or COVID-19antibody testing of faculty and staff prior to reentry into the 761 workplace. In addition, some institutions are considering requiring all study participants to 762 undergo rapid COVID-19 testing prior to in person study activity. Availability and implementation 763 of these tests will vary across institutions. 764

The scientific basis for SARS-CoV-2-related immunity and reliability of antibody testing remains 766 under development. Subject to ongoing scientific insight and respecting regional and 767 institutional guidance, screening for antibodies in the blood of staff or participants could be one 768 element supporting the basis for an "immunity passport" or "risk-free certificate" that would 769 enable individuals to return to work or research assuming that they are protected against re-770 infection. In this respect it should be noted though that a previous infection and the development 771 of immunity may not protect against another episode of infection, and development of the 772 disease (see e.g.

[28]). However, whether the immunity passport policy will apply systematically 773 or not, there is value in specific protocols and based on broader COVID-19 situation factors in 774 applying such tests during recruitment procedures to improve patient-clinician safety or trial 775 integrity. significantly increased the risk of social isolation and associated depression in people with 787 aphasia. Indeed, language and cognitive problems limit the use of digital media (i.e. cellular 788 and/or social network) to maintain social contact. Patients with motor symptoms have also been 789 penalized as a result of COVID-19 since it might be more difficult for them to move or get 790 around with limited caregiver and physical or occupational therapy support. Stroke patients 791 being in an older age category increase the risk of contracting the virus and potentially having a 792 worse outcome; thus, in order to contain the exposure, they will probably be forced to stay-at-793 home for a longer period than young people augmenting the possibility of psychological distress 794 and depression. To address these mental health issues, researchers from the Aphasia research 795

Lab at the IRCCS Santa Lucia Foundation in Rome have launched an online interview in the 796 aphasic population to evaluate whether anxiety and fear towards COVID-19 contagion would 797 discourage the restart of rehabilitation. One concern is that patients worried about COVID-19 798 may be deprioritizing their neurorehabilitation needs and may develop an attitude of resistance 799 towards clinical research, deemed non-essential. 800

Assuming that regulatory agencies and medical centers will hopefully lift the research and 801 clinical treatment suspensions in the coming months when appropriate mitigations plans are in 802 place, it is important to consider that tDCS protocols for motor and/or aphasia rehabilitation will 803 be hampered by the difficulty in maintaining an adequate safety distance during electrodes 804 application and even more importantly by the mandatory use of masks. Indeed, for language 805 and cognitive interventions, it is extremely important that both the therapist and the patient 806 understand each other, being able to see their mouth's movements (i.e. 'lip-reading' is known to 807 facilitate communication). Transparent face shields without masks might be a good alternative 808 option here. However, these will not resolve the question of electrode application while keeping 809 a safety distance. Another possibility is to develop remote, but supervised and controlled 810 interventions at the patient's home using home-based tDCS devices. As appealing as this sounds, considering that most patients have cognitive and physical limitations in applying the 812 'kit' and that NIBS approaches require a peripheral intervention (e.g. traditional speech therapy 813 or physical-occupational therapies), it will be challenging to provide these combined approaches 814 in a patient home. For stroke patients, there might be also an option to develop remote 815 intervention in an outpatient clinical setting ensuring that there is enough separation and 816 physical distance between the patient and the investigators. There is no doubt that requests will 817 be made to regulatory agencies to allow for clinical research in stroke recovery to be conducted 818 in a remote way or at the patient's home by integrating tDCS with other telerehabilitation 819 techniques and digital interventions e.g. computer delivered rehabilitation. In this way, we may 820 resolve the issue related to language distortion due to wearing a cover that, masking not only Considering the construct, telerehabilitation in children has been reported to initially involve 977 face-to-face discussion and education for both the parents and the child [55] . Additionally, 978 specific considerations are indicated for pediatric populations, and integration of parents. In a 979 pediatric telerehabilitation study aiming to increase treatment opportunities in cognitive training 980 for children, Corti et al. integrated assessments of the feasibility of interventions and the study 981 design in the home setting [55] . Key aspects of these assessments included 'accessibility, 982 training compliance, technical smoothness and training motivation', along with assessments of 983 recruitment, enrollment and retention. The authors found integration of the assessments to 984 establish the study well-suited and remarkably high adherence to the protocol. Integrating a COVID-19 response to continue neuromodulation in the pediatric population with 1015 perinatal stroke and resultant cerebral palsy, as well as lack of access recruitment feedback 1016 garnered from our previous work with families nationally and internationally, this remote 1017 investigation will inform future larger externally-funded studies to remotely integrate children 1018 with mobility, financial, and access challenges (e.g. rural communities). 1019 week with 1 day per week in lab/clinic for stimulation. At present, the ACT trial has randomized 1044 307 of 360 older adults targeted for randomization in the trial. As this trial works with a 1045 population at high risk for poor COVID-19 outcomes, in-person study activities were stopped on 1046

March 13, 2020. At this time, 22 participants were actively in the intervention phase of the trial. 1047

As ACT is a definitive Phase III trial near its completion, a late phase change to at-home tDCS procedures would significantly undermine trial integrity for evaluation of definitive benefits from 1049 tDCS paired with cognitive training, as only a small subset of participants would receive the 1050 alternative intervention approach. Even were the current COVID-19 outbreak to occur earlier in 1051 the trial, a significant change in intervention procedures would likely not be feasible for a Phase 1052 III trial. In addition, the primary outcome measure in the ACT trial is currently not available 1053 through telemedicine, further preventing continuation of trial activities through a fully remote 1054 process. In ACT, 22 participants whose interventions were interrupted will need to be replaced. 1055

In addition, approximately 40 participants will miss the timing of their final 1 year follow-up 1056 assessment and MRI visits as of the current date. Careful consideration with the trials data 1057 safety monitoring board and funding agency program office will need to be given regarding 1058 whether these 40 participants will need to be replaced in the trial as well. Pre-COVID-19, ACT 1059 was within 14 months of completion. With the loss of 22 participants, the study will likely not be 1060 completed for 24-26 months. Should the 40 participants missing their 1 year time point need to 1061 be replaced, trial completion could be delayed to 36 months or more. While the extent of delay 1062 is still to be determined, this serves as a poignant example of how COVID-19 is directly 1063 impacting the speed of progress in medical science. This example also further highlights the 1064 critical importance of advancing remotely supervised methods of neuromodulation 1065 administration. In ACT, participants complete cognitive training at home for a large portion of the 1066 trial. Were this initially paired with remote tDCS, the overall impact on ACT would be 1067 significantly reduced. However, lack of availability of primary outcome measures for remote 1068 online or tele-administration would have still led the ACT trial to pause activities. Thus, it is also 1069 important to note that there is a strong need for overarching work attempting to facilitate remote 1070 assessment activities for clinical trials. 1071 1072

This section focuses on not simply accommodating the pandemic situation but using this period 1074 to update or enhance existing NIBS practices using techniques that have already been 1075 validated. We specifically consider telemedicine approaches using tDCS (9.1), accelerating in-1076 clinic TMS procedures (9.2), and introducing new NIBS protocols to address existing and 1077 emerging COVID-19 morbidities (9.3). That said, there has been some concern that the response to theta burst stimulation is highly ability to distill the power of electromagnetic induction as a brain stimulation tool into a 1217 briefcase-sized device has the potential to revolutionize non-invasive neuromodulation as a field. To see this materialize from a fantasy to a reality on the tails of the COVID-19 crisis could, 1219 in fact, be one of the biggest achievements the neuromodulation field may gain from this 1220 experience. It will, however, take talent, time, and investment to make this happen. One should 1221 also balance the safety balance of reducing exposure to the coronavirus with the exposure to 1222 the yet unclear risks of patient self-application of home-based TMS. 1223 1224 9.2.5. Consideration of tDCS as Alternative or Adjunctive Treatment. As discussed above 1225 (Section 9.1). tDCS can be deployed at home with no or minimal required in-person interactions. 1226

On a situation based, providing tDCS as an alternative to TMS or optimized the benefits of TMS 1227 (e.g. tDCS for maintenance of TMS therapy) can be considered [97, 98] . 1228

In conclusion many of the TMS treatment trials that were temporarily halted in March 2020 1230 around the world have begun to put strategies in place to return to enrollment and execution. 1231

These decisions should be made with sensitivity to many factors including the potential risk of 1232 COVID-19 exposure to the participants and staff for in-person visits and the potential benefit to 1233 participants & patients of the intervention. Those trials involved structural or functional imaging 1234 remains restricted based on the opening of imaging facilities. Similarly, any TMS trials involving 1235 parallel in-person protocols (e.g. rehabilitation) are considered in totality. While there will be 1236 many factors that influence this decision for each TMS study, there are some common themes 1237 that will minimize risk (electronic visits when possible, accelerated treatment courses, shorter 1238 pulse sequences like theta burst, use of technological methods such as neuronavigation and 1239 scalp modeling to improve rigor and decrease contact) that not only improve the risk benefit 1240 ratio but will likely lead to a reimagination of the future of TMS delivery-perhaps even launching 1241 a new industry that merges the portability and affordability of tDCS devices with the benefits of 1242 electromagnetic induction as a mechanism of inciting brain change. Survey data were collected from April 30, 2020 to May 6, 2020. To date, data on 9 institutes have been collected from 7 countries. Phase 0 refers to the challenges that affected clinical activities with respect to COVID-19. Phase 1 refers to the activities that have been implemented in response to the pandemic. Phase 2 refers to the precautions planned or already implemented during the reopening of NIBS clinics.

Name of the institution 

• Cessation of non-essential in-person research activities o Followed by determination of compatibility with continuation through valid remote assessment and/or intervention methods

• Movement of study teams to remote work to adhere with stay-at-home mandates o Special consideration required for remote access to resources (hardware, software, etc.)

• Potential continuation of patient studies defined as essential care (e.g., depression), institution-specific determination

• Allow reduced numbers of study team members to remain at work to continue essential study activities (e.g. shift or staggered working patterns)

• Communication with all participants currently enrolled in ongoing studies to provide information regarding how their participation in the study will be impacted by any stay-athome mandates.

o As applicable, communication to participants around any potential risk of COVID-19 transmission in relation to ongoing participation.

• Provide participants with additional information regarding available local resources (e.g. telemental health services, community assistance programs, etc.)

• Training specific staff or consider additional personnel resources for coordinating COVID-19 safety procedures

• Continue remote/teleworking activities such as analyzing data, manuscript writing, grant preparation, virtual meetings, adverse event follow-up, etc.

• Plan for study procedure changes to maximize participant safety and social/physical distancing (e.g., PPE and other safety procedures, facility and equipment disinfection)

• Plan for possible re-integration strategies (tiered, split, etc.) and how the team will adjust to accommodate institutional strategies

• Prioritize study activities that will occur in person once stay-at-home mandates are lifted to account for overburden of study teams due to prior missed visits, upcoming follow-up assessments, and need for new participants to replace those with interrupted and unrecoverable intervention schedules.

• Consider revision of ongoing studies to minimize person-to-person contacts through remote/online/teleassessment for questionnaires, self-report measures and other items not requiring in-person administration

• Consider necessary redesign of study space to minimize participant contact time during intervention delivery

• Further evaluation of feasibility for movement to remote assessment and intervention administration as a precaution for future COVID-19 related stay-at-home mandates.

• Consider procedures for implementation of rapid COVID-19 testing and antibody assays noting and depending on any limitations in current testing and antibody assays regarding sensitivity, specificity or established relevance to risk.

• Explore e-consenting procedures and e-questionnaires etc.

• Consult reputable sources (IRB, CDC, FDA, etc.) for guidance on the timeline for study restart.

• Devise a mitigation plan to limit exposure to Covid-19 or any other infectious agent for study subject/participant as well as research staff

• Immediate implementation of planned procedures and updated safety precautions (i.e. standard operating procedure documents), with appropriate staff training.

• If appropriate procedures for participant/patient safety (PPE, facility design, etc.) and other required procedures are implemented following the first wave of COVID-19, consider how the implementation of rapid COVID-19 testing and antibody assays may allow for the continuation of appropriate in-person activities that were immediately discontinued in the initial emergency response to the first COVID-19 outbreak. This decision will be institution specific.

• Consider creating a financial plan involving possible sources and a calculation on the costs in case of subsequent outbreaks (e.g. the acquisition of all necessary equipment)

Non-Invasive Brain Stimulation for the Treatment of 1411

Substance Use Disorders: Recommendations to a Comprehensive Healthcare Response. An 1414 International Society of Addiction Medicine (ISAM) Practice and Policy Interest Group Position Paper. 1415 Basic and

Repetitive transcranial 1417 magnetic stimulation in stroke rehabilitation: review of the current evidence and pitfalls

Evidence-1420 based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS): An update 1421

Evidence-1423 based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS)

Evidence-1426 based guidelines on the therapeutic use of transcranial direct current stimulation (tDCS)

Non-invasive brain stimulation in 1429 generalized anxiety disorder: A systematic review

Repetitive transcranial 1432 magnetic stimulation for treatment-resistant depression: a systematic review and meta-analysis

Magnetic Stimulation for Treatment-Resistant Depression in Adult and Youth Populations: A Systematic 1436

Literature Review and Meta-Analysis

Are we facing a crashing wave of neuropsychiatric sequelae of

COVID-19? Neuropsychiatric symptoms and potential immunologic mechanisms

PTSD as the second tsunami of the SARS-Cov-2 pandemic

International Society for ECT and Neurostimulation

The psychological impact of the COVID-19 1444 epidemic on college students in China

Mental health care for international Chinese students affected by the COVID-19 1446 outbreak

Suicide risk and 1448 prevention during the COVID-19 pandemic

Gender Imbalance at Brain Stimulation Conferences: We Have a Problem and It is 1450

Everyone's Problem

Gender Imbalance at Brain Stimulation 1452 Conferences: We Have a Problem and It is Everyone's Problem'

A room of one's own. London: 1454 Leonard and Virginia Woolf at the Hogarth Press

Early journal submission data suggest COVID-19 is tanking women's research productivity

The Production of Inequality: The Gender Division 1459 of Labor Across the Transition to Parenthood

The pandemic and the female academic

Transmission Route of COVID-19: Why 2 Meters/6 Feet of Inter-Personal Distance Could Not Be Enough

Persistence of coronaviruses on inanimate surfaces 1465 and their inactivation with biocidal agents

Radiology Department 1467 Preparedness for COVID-19: Radiology Scientific Expert Panel

Respirators and surgical facemasks 1469 for COVID-19: implications for MRI

Risk factors of critical & mortal COVID-19 1471 cases: A systematic literature review and meta-analysis

Transcranial Cerebellar Direct Current 1476

Stimulation Enhances Verb Generation but Not Verb Naming in Poststroke Aphasia

Combining Voxel-based Lesion-symptom Mapping 1479 (VLSM) With A-tDCS Language Treatment: Predicting Outcome of Recovery in Nonfluent Chronic 1480

High-Definition Transcranial Direct 1482

Current Stimulation Improves Verb Recovery in Aphasic Patients Depending on Current Intensity

Combined central and peripheral stimulation to facilitate motor 1485 recovery after stroke: the effect of number of sessions on outcome

Bihemispheric brain stimulation facilitates 1488 motor recovery in chronic stroke patients

Non-invasive brain stimulation enhances the effects of melodic 1490 intonation therapy

The use of non-invasive brain stimulation techniques to 1492 facilitate recovery from post-stroke aphasia

Transcranial Direct Current Stimulation in Poststroke Aphasia 1494 Recovery

Transcranial Direct Current 1496 Stimulation for Poststroke Motor Recovery: Challenges and Opportunities

The potential effects of transcranial direct current stimulation (tDCS) on language 1499 functioning: Combining neuromodulation and behavioral intervention in aphasia

Non-Invasive Brain 1502

Stimulation in Children With Unilateral Cerebral Palsy: A Protocol and Risk Mitigation Guide

Non-invasive Brain Stimulation for the Rehabilitation of 1505 Children and Adolescents With Neurodevelopmental Disorders: A Systematic Review

Collision of the COVID-19 and Addiction Epidemics

Characteristics of and Important Lessons From the Coronavirus Disease 1509 2019 (COVID-19) Outbreak in China: Summary of a Report of 72314 Cases From the Chinese

Disease Control and Prevention

Delivering Transcranial Direct Current Stimulation Away From 1512 Clinic: Remotely Supervised tDCS

Stimulation Is Feasible for Remotely Supervised Home Delivery in Multiple Sclerosis

Transcranial Direct Current Stimulation: An Update on Safety and Tolerability

Transcranial Direct Current Stimulation Increases the Benefit of At-Home Cognitive Training in Multiple 1520 Sclerosis

Remotely supervised transcranial 1522 direct current stimulation for the treatment of fatigue in multiple sclerosis: Results from a randomized, 1523 sham-controlled trial

Generalizing remotely 1525 supervised transcranial direct current stimulation (tDCS): feasibility and benefit in Parkinson's disease

Long term at-home treatment 1528 with transcranial direct current stimulation (tDCS) improves symptoms of cerebellar ataxia: a case report

Direct Current Stimulation After ECT Improves Mood and Cognition in a Patient With Multiple Sclerosis: A 1532 Case Study

Telerehabilitation benefits patients with multiple 1534 sclerosis in an urban setting

COVID-19 transforms health care through 1536 telemedicine: evidence from the field

Applications of transcranial direct 1538 current stimulation in children and pediatrics

Assessing patient safety in a 1540 pediatric telemedicine setting: a multi-methods study

Feasibility of a home-1542 based computerized cognitive training for pediatric patients with congenital or acquired brain damage: An 1543 explorative study

Supervised transcranial direct current 1545 stimulation (tDCS) at home: A guide for clinical research and practice

transcranial direct current stimulation plus tracking training therapy in people with stroke: an open-label 1549 feasibility study

Single-session tDCS in Cerebral Palsy

Alternating Current 1552 Stimulation for Vision Restoration after Optic Nerve Damage: A Randomized Clinical Trial

Augmenting cognitive training 1555 in older adults (The ACT Study): Design and Methods of a Phase III tDCS and cognitive training trial

Treating the mental health effects of COVID-19: The need for at-home 1558 neurotherapeutics is now

Pilot trial of home-administered transcranial 1560 direct current stimulation for the treatment of depression

Remotely supervised transcranial direct 1562 current stimulation: A feasibility study for amyotrophic lateral sclerosis

Do Not Forget Afghanistan in Times of COVID-19: Telemedicine 1565 and the Internet of Things to Strengthen Planetary Health Systems

Ramping up telemedicine in pediatric urology-Tips for 1567 using a new modality

Updated Technique for Reliable

Tolerated Transcranial Electrical Stimulation Including Transcranial Direct Current Stimulation

Successful replacement of electroconvulsive treatment (ECT) with transcranial 1572 direct current stimulation (tDCS) in severe, treatment-refractory catatonic schizophrenia: Case study

Comparative efficacy and 1575 acceptability of non-surgical brain stimulation for the acute treatment of major depressive episodes in 1576 adults: systematic review and network meta-analysis

Safety and 1578 acceptability of transcranial direct current stimulation for the acute treatment of major depressive 1579 episodes: Analysis of individual patient data

Low intensity 1581 transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines

Safety of Transcranial 1584 Direct Current Stimulation: Evidence Based Update

Application of Transcranial Electrical Stimulation with Limited Outputs to Healthy Subjects

ELectrical Current Therapy for Treating Depression Clinical Trial--SELECT TDCS: design, rationale and 1590 objectives

Transcranial Direct-Current Stimulation 1592 (tDCS) Versus Venlafaxine ER In The Treatment Of Depression: A Randomized, Double-Blind

Efficacy 1595 and Safety of Transcranial Direct Current Stimulation as an Add-on Treatment for Bipolar Depression: A 1596 Randomized Clinical Trial

A systematic review and 1598 meta-analysis on the effects of transcranial direct current stimulation in depressive episodes

Transcranial direct 1601 current stimulation for acute major depressive episodes: meta-analysis of individual patient data

Transcranial direct 1604 current stimulation in psychiatric disorders

Theta burst stimulation of the human 1606 motor cortex

Effectiveness 1608 of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with 1609 depression (THREE-D): a randomised non-inferiority trial

Interindividual variability in 1611 response to continuous theta-burst stimulation in healthy adults

Repetitive transcranial 1614 magnetic stimulation treatment for depressive disorders: current knowledge and future directions

Accelerated 1617 repetitive transcranial magnetic stimulation in the treatment of depression

Accelerated 1620 repetitive transcranial magnetic stimulation for treatment-resistant depression

High-dose 1625 spaced theta-burst TMS as a rapid-acting antidepressant in highly refractory depression

A clinical repetitive transcranial magnetic stimulation 1628 service in Australia: 6 years on

Evaluating Transcranial Magnetic Stimulation as a Tool to Reduce Smoking Directly 1630 Following a Quit Attempt

Theta Burst Stimulation as a Tool to Decrease Drinking in Treatment-seeking Alcohol Users

Transcranial Magnetic Stimulation for the Treatment of Veterans With Alcohol Use Disorders

A multicenter, 1642 prospective, single arm, open label, observational study of sTMS for migraine prevention (ESPOUSE 1643 Study)

Personalized TMS helmets for quick and reliable TMS administration outside of a laboratory setting

The Efficacy of Miniaturized Repetitive Transcranial Magnetic 1648 Stimulation in Patients with Depression

Transcranial Brain Stimulation Techniques For Major Depression: 1650 Should We Extend TMS Lessons to tDCS?

Patient-delivered tDCS on 1652 chronic neuropathic pain in prior responders to TMS (a randomized controlled pilot study)

Initial psychological responses to Influenza A, H1N1 1655

Psychological and Behavioral Responses in South Korea During the Early Stages 1657 of Coronavirus Disease 2019 (COVID-19)

The psychological impact of the COVID-19 1660 epidemic on college students in China

A Longitudinal Study on the Mental 1665 Health of General Population during the COVID-19 Epidemic in China

Suicide risk and 1667 prevention during the COVID-19 pandemic

Long-term psychiatric morbidities among SARS 1669 survivors

Factors Associated With Mental Health Outcomes 1671

Among Health Care Workers Exposed to Coronavirus Disease

Generalized anxiety disorder, depressive symptoms and sleep quality during 1674

COVID-19 epidemic in China: a web-based cross-sectional survey

Exposure During COVID-19 Outbreak

Mental 1678 resilience in the Corona lockdown: First empirical insights from Europe. PsyArXiv

Patients with mental health disorders in the COVID-19 epidemic. The 1680

Mental health services for older adults in 1682 China during the COVID-19 outbreak

Cancer patients in 1684 covid-19 era: swimming against the tide

Dementia care during 1686 COVID-19

The Impact of the COVID-19 Pandemic on Parkinson's Disease: Hidden 1688 Sorrows and Emerging Opportunities

Caring for 1690 patients with pain during the COVID-19 pandemic: consensus recommendations from an international 1691 expert panel

Treating multiple sclerosis and 1693 neuromyelitis optica spectrum disorder during the COVID-19 pandemic

Protocols of non-invasive brain stimulation for 1695 neuroplasticity induction

A systematic review on the 1697 therapeutic effectiveness of non-invasive brain stimulation for the treatment of anxiety disorders

Transcranial magnetic stimulation and transcranial direct current 1700 stimulation: treatments for cognitive and neuropsychiatric symptoms in the neurodegenerative 1701 dementias

Transcranial Direct Current 1703 Stimulation for Obsessive-Compulsive Disorder: A Systematic Review

Transcranial magnetic 1705 stimulation in obsessive-compulsive disorder: A focus on network mechanisms and state dependence

Noninvasive Brain 1708 Stimulation in Pediatric ADHD: A Review

Cognitive effects of treatment 1710 of depression with repetitive transcranial magnetic stimulation

Noninvasive 1712 transcranial direct current stimulation over the left prefrontal cortex facilitates cognitive flexibility in tool 1713 use

Stimulation Improves Executive Dysfunctions in ADHD: Implications for Inhibitory Control

Working Memory, and Cognitive Flexibility

Improvements in emotion 1718 regulation following repetitive transcranial magnetic stimulation for generalized anxiety disorder

Acute reduction in anxiety after deep transcranial 1721 magnetic stimulation (DTMS) in unipolar major depression-a systematic review and meta-analysis

Direct Current Stimulation on Obsession-Induced Anxiety in Refractory Obsessive-Compulsive Disorder: 1725 A Pilot Study

Clinical assessment of Tourette syndrome and tic disorders

Stress affects hedonic responses but not reaching-grasping 1729 in Parkinson's disease

Effect of daily repetitive transcranial 1731 magnetic stimulation on motor performance in Parkinson's disease

Repetitive 1733 transcranial magnetic stimulation (rTMS) in the treatment of obsessive-compulsive disorder

Tourette's syndrome (TS)

A first case of 1736 meningitis/encephalitis associated with SARS-Coronavirus-2

Neurologic Manifestations of Hospitalized 1739

Patients With Coronavirus Disease

System Involvement by Severe Acute Respiratory Syndrome Coronavirus -2 (SARS-CoV-2)

Repetitive transcranial 1744 magnetic stimulation reduces remote apoptotic cell death and inflammation after focal brain injury

Therapeutic Effects of Repetitive Transcranial Magnetic Stimulation (rTMS) on Neuroinflammation and 1748

Neuroplasticity in Patients with Parkinson's Disease: a Placebo-Controlled Study

Magnetic Stimulation on Disorders of Consciousness: A Resting-State Electroencephalography Study

Magnetic Stimulation of the Left Dorsolateral Prefrontal Cortex in Disorders of Consciousness. Front

Transcranial direct current stimulation in disorders of consciousness: a review

Can 8 months of daily tDCS application slow 1759 the cognitive decline in Alzheimer's disease? A case study

Remotely Controlled Transcranial Direct Current Stimulation: A Systematic Review of the 1762

behaviors such as social isolation, substance abuse or suicide attempts might also surge [2, 1253 102, 104]. Accordingly, depressive and post-traumatic symptoms have been constantly reported 1254 and found to persist even 2.5 years after epidemics [105] . Evidence that similar symptoms are 1255 present among health care professionals and the general population during the COVID-19 1256 outbreak is already emerging from China, the epicenter of the outbreak [103, [106] [107] [108] , and 1257 from Europe as well [109] . protocols. This could span changing methods and access to prescribed medications (e.g. ability 1307 to diagnose, monitor for adverse events) as well as any consideration of unexpected 1308 interactions between drugs (e.g. psychotropics) and antiviral medication. A general feature of 1309 NIBS is its non-drug non-systematic application nature, non-addictive nature, and ability to 1310 terminate or adjust dose (in clinic or remote for home-based treatment) and vice versa. Clearly, 1311 there is potential for NIBS as a unique treatment tool in the fight against the medical and 1312 psychological after-effects of the COVID-19 outbreak. 1313 1314

The COVID-19 pandemic, just like all crises, has yielded challenges for researchers, clinicians, 1316 participants and patients, but also lessons to learn from and new opportunities to pursue. By 1317 synthesizing the experiences of experts from all over the world, this consensus paper 1318 establishes practical recommendations to follow in operationalizing NIBS during COVID-19 1319 pandemic, mitigating the risk of infections, and in preparing the NIBS community for any future 1320 epidemic/pandemic. Indeed, as we emerge from the current pandemic, the number of people 1321 who require innovative treatments such as NIBS due to direct and indirect effects of COVID-19 1322 onto the brain and mental health will significantly increase. This burden on the health care 1323 systems mandates broader investigation and adoption of therapeutic solutions such as the use 1324 of NIBS. For NIBS laboratories and clinics to contribute to the ease the burden of the pandemic, 1325it is necessary to re-establish operation with prudent protocol modifications as soon as possible. • None mentioned • Implementation of teleconsultation 

We wish to confirm that there are no known conflicts of interest associated with this publication and there has been no significant financial support for this work that could have influenced its outcome.We confirm that the manuscript has been read and approved by all named authors and that there are no other persons who satisfied the criteria for authorship but are not listed. We further confirm that the order of authors listed in the manuscript has been approved by all of us.We confirm that we have given due consideration to the protection of intellectual property associated with this work and that there are no impediments to publication, including the timing of publication, with respect to intellectual property. In so doing we confirm that we have followed the regulations of our institutions concerning intellectual property.We understand that the Corresponding Author is the sole contact for the Editorial process (including Editorial Manager and direct communications with the office). He/she is responsible for communicating with the other authors about progress, submissions of revisions and final approval of proofs. We confirm that we have provided a current, correct email address which is accessible by the Corresponding Author and which has been configured to accept email from (hekhtiari@laureateinstitute.org).