133172 - N-of-1 trials for closed loop.pdf (234.67 kB)
N-of-1 trials for closed-loop deep brain stimulation devices
journal contribution
posted on 2023-05-20, 04:19 authored by Stevens, I, Frederic GilbertFrederic GilbertClosed‐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.
Funding
Australian Research Council
History
Publication title
Ethics & Human ResearchVolume
42Pagination
28-33ISSN
2578-2355Department/School
School of HumanitiesPublisher
Wiley-Blackwell Publishing, Inc.Place of publication
USARights statement
© 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:Repository Status
- Restricted