Artificial intelligence (AI)-controlled closed-loop deep-brain stimulation (DBS) devices have shown great promise in treating various neurological and psychiatric conditions. These algorithmic based closed-loop DBS devices provide a personalized treatment to each patient. The conventional quantitative methods of testing medical treatments utilize a randomized double-blind model involving dozens to hundreds of subjects. Separately, modern precision research practices utilize N-of-1 trials to account for variability in each patient’s genes and physiology. Currently, AI-controlled DBS trials have been evaluated by the conventional quantitative double-blind method as opposed to those more analogous to an N-of-1 trial. Accordingly, these trials may face challenges to incorporate the personalized closed-loop algorithms responding to patient-specific dysfunctional brain states to understand the safety and efficacy of these devices as neurological treatments. Therefore, this conventional approach may fails to include the unique qualitative effects these therapeutic algorithms potentially have on each patient’s personal mental health and impact their psychological continuity. This manuscript explores the personal nature of DBS treatments to explore the future priority of N-of-1 trials in specifically closed-loop DBS clinical research. Evaluating these differences and exploring the implementation of N-of-1 trials could provide patients, their medical provides, and their families with better grounds in which to make informed consent about pursuing this treatment option. Similarly, utilizing N-of-1 trials could contribute qualitative data of closed-loop DBS treatments to provide solutions to a number the ethical dilemmas relating to a patient’s informed consent.

Item Type:	Refereed Article
Keywords:	brain-computer interfaces, N-of-1, ethics
Research Division:	Philosophy and Religious Studies
Research Group:	Applied Ethics
Research Field:	Ethical Use of New Technology (e.g. Nanotechnology, Biotechnology)
Objective Division:	Expanding Knowledge
Objective Group:	Expanding Knowledge
Objective Field:	Expanding Knowledge in Philosophy and Religious Studies
UTAS Author:	Gilbert, F (Dr Frederic Gilbert)
ID Code:	133172
Year Published:	In Press
Funding Support:	Australian Research Council (DE150101390)
Deposited By:	College Office - CALE
Deposited On:	2019-06-16
Last Modified:	2019-12-16
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