Brain Technology – and Bioethics – on the Brink

“…On the brink” (Engl. Idiom): Poised to be in a new, exciting and/or dangerous

James Giordano, PhD, MPhil

The National Academy of Medicine (of the National Academies of Science, Engineering and Medicine, NASEM) has just released a set of well-crafted discussion papers on non-invasive neuromodulatory technology; regenerative medicine; and telehealth technologies, which present interesting cases – and address of key issues – for professional, scholarly, and public discourse and education. Working in the neurotechnology field for the past four decades, it was with particular interest that I read the Academy’s perspective/discussion paper by Matthews, Abernathy, et al. on transcranial electrical stimulation (TES). In general, the case was well presented, and certainly representative of the type of issues and questions that can, and often do arise in and from the use of TES.

To be sure, there has been considerable work to assess the validity, viability, and potential value of transcranial direct current stimulation (tDCS), in clinical, para-clinical (i.e.- occupational), and wellness/lifestyle settings, and the ethico-legal and social issues (ELSI) fostered by such uses. While the NAM paper nicely covers the focal concerns of the case, and provides literature to support current views and positions, so there are additional resources that are important to more deeply elucidating both the diversity of non-invasive neurotechnologies that are presently in use, and the questions, issues and guidance and regulation(s) available to direct how such devices can and
should be used (and/or not used).

Our group has provided a summary of tDCS technology, putative mechanisms, effects, and ELSI, and addressed some of its off-label uses and value. The use of transcranial electrical stimulation (of which there are, in fact a number of types, tDCS being one, others include transcranial alternating current stimulation- tACS, and (non-invasive) forms of vagal nerve stimulation – VNS) is pretty much a fait accompli, and has ever widening direct-to-consumer (DTC) and do-it-yourself (DIY) user communities. To this point, the work of Bikson et al. (Brain Stimulation, 2018) that served to inform revised FDA and Consumer Affairs’ guidelines on DTC considerations and constraints of low output transcranial electrical stimulation (LOTES); and the concerns about – and invitation for more open exchange of information with – the DIY community voiced by Wurman and colleagues (Annals of Neurology, 2016) are, I believe, important to regarding the recent focus, and scope of the discourse.

Yet, TES is but one approach in the non-invasive toolkit, and while certainly easy and relatively economical, and thus useful, is viewed as somewhat limited in effect, benefit and application, at least in its present iterations (a perspective prompting additional research, development and innovation in TES science and technology). More robust effects have been demonstrated by the use of transcranial magnetic stimulation, and the ELSI are similar to those addressed in the National Academy discussion paper, specifically given that TMS is currently not available in DTC, or engaged in DIY markets.

The discussion paper brings to light some of the work conducted in studies funded by the Defense Advanced Research Projects Agency (DARPA), which were constituent to a larger research portfolio within the federal Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative. While tDCS approaches were certainly part of those programs’ toolkits, many projects were more specifically focused upon exploring the utility – and ELSI – of TMS, and ever more sophisticated, effective, and facile types of deep brain stimulation (DBS). Such indwelling technology is now becoming far more contentious given the presence, and potential leverage that Elon Musk’s Neuralink may have upon the global uptake of implantable neurotechnologies,
and the manifest ethico-legal and socio-economic impacts that this may have on medical tourism.

This is important because when taken together, these investigations and trials (within the Systems-based Neurotechnology for Emerging Therapies-SUBNETS; and Resorting Active Memory – RAM and RAM-Replay project portfolios) were instrumental in prompting what I regard as one of the most innovative, provocative – and in some ways controversial – endeavors to conjoin cutting edged neuroscience, neuroengineering and
data/computational methods: the Next Generation Non-invasive Neuromodulation (N3) program. As the title defines, the aim is to develop a set of non-invasive (or minimally invasive) methods of implanting a vast array of nano-scale sensing and transmitting electrodes in within defined nodes and networks of the brain, so as to enable real-time, remote exchange of information to and from the brain (via a system similar to WiFi and computational cloud technologies). If we consider that the function(s) of the brain (at least in some way) can be considered to be “the mind”, then the N3 Project, if successful, will as matter of fact, have achieved the capability for “mind reading” and “mind control” at-a-distance. This generates ELSI of non-invasive neuromodulation in extremis; and these questions and problems are surely recognized, acknowledged and being addressed – both by/within DARPA, and more broadly.

So, perhaps, the greatest value of this National Academy of Medicine Perspectives series release is not merely providing substance for the discussion of a specific case, or even regard for ELSI of non-invasive neuromodulation (as well as regenerative medicine and telehealth), but rather awareness that these tools and methods are both the “tip of the iceberg” of emerging biotechnologies, and the “tip of the tiger’s tail” of the ELSI that such developments foster. Such bold new biotechnology demands brave bioethics to remain apace and ahead of the benefits, burdens, risk and threats posed on an increasingly multipolar world stage. It is pragmatic and prudent to ask if, and to what extent current ethico-legal approaches may be best suited to address and adjudicate the widening ELSI fostered by these emerging techniques and technologies, and if the current ethical kit requires revisitation, revision, and/or the addition of supplemental tools. Our group, working with international colleagues, remains dedicated to this task,
challenge, and opportunity.

Dr James Giordano is Pellegrino Center Professor of Neurology and Biochemistry; and Chief of the Neuroethics Studies Program at GeorgetownUniversity Medical Center, Washington, DC. As well he is Senior Bioethicist of the US Department of Defense Medical Ethics Center; and Chair Emeritus of the Neuroethics and Neurotechnology Program of the IEEE Brain Initiative. He has previously served as an appointed member of the US Department of Health and Human Services Secretary’s Advisory Committee
for Human Research Protections; the Neuroethical Legal and Social Issues Advisory Board of the Defense Advanced Research Projects Agency BRAIN Initiative Portfolio; Neurotechnology Working Group of the Organisation for Economic Cooperation and Development (OECD); and Senior Fellow of the Ethics Group of the European Union Human Brain Project. His newest book, ‘Bioethics and Brains: A Disciplined and Principled Neuroethics’, with co-author John Shook, will be published by MIT Press in Summer 2024.

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