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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

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 d...

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Autores principales: Bikson, Marom, Ganho-Ávila, Ana, Datta, Abhishek, Gillick, Bernadette, Joensson, Morten Goertz, Kim, Sungjin, Kim, Jinuk, Kirton, Adam, Lee, Kiwon, Marjenin, Timothy, Onarheim, Balder, Rehn, Erik M., Sack, Alexander T., Unal, Gozde
Formato: Online Artículo Texto
Lenguaje:English
Publicado: 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10350287/
https://www.ncbi.nlm.nih.gov/pubmed/37201865
http://dx.doi.org/10.1016/j.brs.2023.05.008
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author Bikson, Marom
Ganho-Ávila, Ana
Datta, Abhishek
Gillick, Bernadette
Joensson, Morten Goertz
Kim, Sungjin
Kim, Jinuk
Kirton, Adam
Lee, Kiwon
Marjenin, Timothy
Onarheim, Balder
Rehn, Erik M.
Sack, Alexander T.
Unal, Gozde
author_facet Bikson, Marom
Ganho-Ávila, Ana
Datta, Abhishek
Gillick, Bernadette
Joensson, Morten Goertz
Kim, Sungjin
Kim, Jinuk
Kirton, Adam
Lee, Kiwon
Marjenin, Timothy
Onarheim, Balder
Rehn, Erik M.
Sack, Alexander T.
Unal, Gozde
author_sort Bikson, Marom
collection PubMed
description 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.
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spelling pubmed-103502872023-07-16 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 Bikson, Marom Ganho-Ávila, Ana Datta, Abhishek Gillick, Bernadette Joensson, Morten Goertz Kim, Sungjin Kim, Jinuk Kirton, Adam Lee, Kiwon Marjenin, Timothy Onarheim, Balder Rehn, Erik M. Sack, Alexander T. Unal, Gozde Brain Stimul Article 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. 2023 2023-05-16 /pmc/articles/PMC10350287/ /pubmed/37201865 http://dx.doi.org/10.1016/j.brs.2023.05.008 Text en https://creativecommons.org/licenses/by/4.0/This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) ).
spellingShingle Article
Bikson, Marom
Ganho-Ávila, Ana
Datta, Abhishek
Gillick, Bernadette
Joensson, Morten Goertz
Kim, Sungjin
Kim, Jinuk
Kirton, Adam
Lee, Kiwon
Marjenin, Timothy
Onarheim, Balder
Rehn, Erik M.
Sack, Alexander T.
Unal, Gozde
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10350287/
https://www.ncbi.nlm.nih.gov/pubmed/37201865
http://dx.doi.org/10.1016/j.brs.2023.05.008
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