Limited output transcranial electrical stimulation 2023 (LOTES-2023): Updates on engineering principles, regulatory statutes, and industry standards for wellness, over-the-counter, or prescription devices with low risk

Marom Bikson, Ana Ganho-Ávila, Abhishek Datta, Bernadette Gillick, Morten Goertz Joensson, Sungjin Kim, Jinuk Kim, Adam Kirton, Kiwon Lee, Timothy Marjenin, Balder Onarheim, Erik M Rehn, Alexander T Sack, Gozde Unal, Marom Bikson, Ana Ganho-Ávila, Abhishek Datta, Bernadette Gillick, Morten Goertz Joensson, Sungjin Kim, Jinuk Kim, Adam Kirton, Kiwon Lee, Timothy Marjenin, Balder Onarheim, Erik M Rehn, Alexander T Sack, Gozde Unal

Abstract

The objective and scope of this Limited Output Transcranial Electrical Stimulation 2023 (LOTES-2023) guidance is to update the previous LOTES-2017 guidance. These documents should therefore be considered together. The LOTES provides a clearly articulated and transparent framework for the design of devices providing limited output (specified low-intensity range) transcranial electrical stimulation for a variety of intended uses. These guidelines can inform trial design and regulatory decisions, but most directly inform manufacturer activities - and hence were presented in LOTES-2017 as "Voluntary industry standard for compliance controlled limited output tES devices". In LOTES-2023 we emphasize that these standards are largely aligned across international standards and national regulations (including those in USA, EU, and South Korea), and so might be better understood as "Industry standards for compliance controlled limited output tES devices". LOTES-2023 is therefore updated to reflect a consensus among emerging international standards, as well as best available scientific evidence. "Warnings" and "Precautions" are updated to align with current biomedical evidence and applications. LOTES standards applied to a constrained device dose range, but within this dose range and for different use-cases, manufacturers are responsible to conduct device-specific risk management.

Conflict of interest statement

Declaration of competing interest The City University of New York holds patents on brain stimulation with MB as inventor. MB has equity in Soterix Medical Inc. MB consults, received grants, assigned inventions, and/or served on the SAB of Safe Toddles, Boston Scientific, GlaxoSmithKline, Biovisics, Mecta, Lumenis, Halo Neuroscience, Google-X, i-Lumen, Humm, Allergan (Abbvie), Apple, Ybrain, Ceragem, Remz. MB is supported by grants from Harold Shames and the National Institutes of Health: NIH-NIDA UG3DA048502, NIH-NIGMS T34 GM137858, NIH-NINDS R01 NS112996, NIH-NINDS R01 NS101362, and NIH-G-RISE T32GM136499. AG-A serves as consultant and has non-financial/material support from Flow Neuroscience in tDCS equipment. ATS is Chief Scientific Advisor of PlatoScience and Alphasys, CEO of Neurowear Medical B.V., received equipment support from MagVenture, Deymed, and MagStim Company, and is Scientific Director of the International Clinical TMS Certification Course. ER has equity in and is an employee of Flow Neuroscience. ER is an inventor of patents related to brain stimulation. BHO has equity in and is the director of PlatoScience ApS, a company manufacturing LOTES devices. PlatoScience and BHO are listed on patents and patent applications related to LOTES devices. MGJ is an employee of PlatoScience ApS, a company manufacturing LOTES devices. PlatoScience are listed on patents and patent applications related to LOTES devices. SK, JK and KL are employees of Ybrain. AD is an employee in Soterix Medical Inc. The City University of New York holds patents on brain stimulation with AD as inventor. AD is supported by grants from NIH: NIH-NIDA-75N95020C00024, DoD: W912CG21C0014 and W81XWH22C0111, NASA: 80NSSC22CA071, ED:91990022C0043. GU consulted for Halo Neuroscience.

Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.

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