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N-of-1 trials for closed-loop deep brain stimulation devices


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Stevens, I and Gilbert, F ORCID: 0000-0003-0524-8649 2020 , 'N-of-1 trials for closed-loop deep brain stimulation devices' , Ethics & Human Research, vol. 42, no. 2 , pp. 28-33 , doi: 10.1002/eahr.500045.

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Closed‐loop deep brain stimulation (DBS) devices hold great promise for treating various neurological and psychiatric conditions. Yet while these algorithmic‐based devices provide personalized treatment to each patient, they also present uniquely individualized risks of physiological and psychological harms. These experimental devices are typically tested in randomized controlled trials, which may not be the optimum approach to identifying and assessing phenomenological harms they pose to patients. In this article, we contend that an N‐of‐1 trial design—which is being used ever more frequently to realize the goals of individualized, precision medicine—could provide beneficial phenomenological data about the potential risks of harm to properly inform the use of closed‐loop DBS devices. Data from N‐of‐1 trials may provide patients, as well as their families and other caregivers, with better information on which to base informed choices about pursuing this type of treatment option.

Item Type: Article
Authors/Creators:Stevens, I and Gilbert, F
Keywords: brain-computer interfaces, N-of-1, ethics
Journal or Publication Title: Ethics & Human Research
Publisher: Wiley-Blackwell Publishing, Inc.
ISSN: 2578-2355
DOI / ID Number: 10.1002/eahr.500045
Copyright Information:

© 2020 by The Hastings Center. All rights reserved. This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Use of Self-Archived Versions. This is the peer reviewed version of the following article: Stevens, I and Gilbert, F, N-of-1 trials for closed-loop deep brain stimulation devices, Ethics & Human Research, 42, (2) pp. 28-33. ISSN 2578-2355 (2020), which has been published in final form at:

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