Abstract
Interest and investment in closed-loop or adaptive deep brain stimulation (aDBS) systems have quickly expanded due to this neurotechnology’s potential to more safely and effectively treat refractory movement and psychiatric disorders compared to conventional DBS. A large neuroethics literature outlines potential ethical concerns about conventional DBS and aDBS systems. Few studies, however, have examined stakeholder perspectives about ethical issues in aDBS research and other next-generation DBS devices. To help fill this gap, we conducted semi-structured interviews with researchers involved in aDBS trials (n = 23) to gain insight into the most pressing ethical questions in aDBS research and any concerns about specific features of aDBS devices, including devices’ ability to measure brain activity, automatically adjust stimulation, and store neural data. Using thematic content analysis, we identified 8 central themes in researcher responses. The need to measure and store neural data for aDBS raised concerns among researchers about data privacy and security issues (noted by 91% of researchers), including the avoidance of unintended or unwanted third-party access to data. Researchers reflected on the risks and safety (83%) of aDBS due to the experimental nature of automatically modulating then observing stimulation effects outside a controlled clinical setting and in relation to need for surgical battery changes. Researchers also stressed the importance of ensuring informed consent and adequate patient understanding (74%). Concerns related to automaticity and device programming (65%) were discussed, including current uncertainties about biomarker validity. Additionally, researchers discussed the potential impacts of automatic stimulation on patients’ autonomy and control over stimulation (57%). Lastly, researchers discussed concerns related to patient selection (defining criteria for candidacy) (39%), challenges of ensuring post-trial access to care and device maintenance (39%), and potential effects on personality and identity (30%). To help address researcher concerns, we discuss the need to minimize cybersecurity vulnerabilities, advance biomarker validity, promote the balance of device control between patients and clinicians, and enhance ongoing informed consent. The findings from this study will help inform policies that will maximize the benefits and minimize potential harms of aDBS and other next-generation DBS devices.
Highlights
MATERIALS AND METHODSAdaptive deep brain stimulation devices are part of the emerging field of personalized neurointerventions that are responsive to a patient’s neural activity
In an effort to understand researchers’ perspectives on the key neuroethics considerations related to the development of AND METHODSAdaptive deep brain stimulation (aDBS) devices, we conducted interviews with researchers working in aDBS studies, who provided critical insights into the concerns raised by the capabilities and limitations of these devices. Drawing from these interviews, we identify pressing neuroethics issues and concerns, some of which apply to conventional DBS, but many of which are distinctive of or exacerbated by aDBS devices
We identified eight overarching themes in researchers’ responses to six questions about neuroethical concerns and challenges in aDBS research (Table 2)
Summary
MATERIALS AND METHODSAdaptive deep brain stimulation (aDBS) devices are part of the emerging field of personalized neurointerventions that are responsive to a patient’s neural activity. The goal of aDBS systems is to deliver stimulation only when pathological brain activity is detected in order to prevent overtreatment, decrease side effects (e.g., hypomania), and battery depletion, which requires surgical replacement (Hosain et al, 2014; Beudel and Brown, 2016; Shukla et al, 2017). In addition to these safety advantages, aDBS may lead to better outcomes for patients because it adjusts automatically, avoiding the delay between suboptimal symptom management and adjustment of stimulation in a clinical encounter (Klein, 2020, p.336). Addressing ethical concerns related to these defining features of closed-loop DBS may help to promote safety and efficacy, with potentially broader implications for other next-generation DBS devices containing with similar features
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