N‐of‐1 Trials for Closed‐Loop Deep Brain Stimulation Devices. Issue 2 (19th March 2020)

• Record Type: Journal Article
• Authors: Stevens, Ian; Gilbert, Frederic
• Is Part Of: Ethics & human research. Volume 42:Issue 2(2020)
• Page Start: 28
• Page End: 33
• Publication Date: 2020-03-19
• Subjects: deep brain stimulation -- closed‐loop deep brain stimulation -- N‐of‐1 trials -- randomized controlled trials -- medical treatment algorithm -- informed consent -- human subjects research; Medical ethics -- United States -- Periodicals; Human experimentation in medicine -- Periodicals; Informed consent (Medical law) -- United States -- Periodicals; 174.2805
• DOI: 10.1002/eahr.500045
• Languages: English
• ISSNs: 2578-2355

Abstract

ABSTRACT: 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.