ABSTRACT A fundamental ethical tenet in medicine is bodily sovereignty, inherent in which is the concept of control. Over the past 10 years, there has been considerable discussion in the neuroethics literature concerning the loss of control attributed to neuromodulation devices, specifically deep brain stimulation (DBS), with a focus on reduced control related to undesired personality changes. Many of these concerns either explicitly or implicitly focus on the invasiveness of the DBS device. We have conducted prospective empirical studies examining the impact of DBS on different aspects of control that are personally meaningful to patients (i.e., global control, control of valued functional goals, and control of valued personality characteristics). Our data show that DBS significantly improves control of these personally meaningful variables. However, our findings are limited in that we did not assess directly the differential impact of invasive versus non-invasive surgery on control. The proposed study uses patients with essential tremor who undergo either an invasive (DBS) or non-invasive (MRI guided focused ultrasound) surgery to treat their tremor as a model to study the importance of surgical invasiveness by: 1) studying different stakeholders' (i.e., physicians, patients) understandings of invasiveness, how those understandings impact surgical decision-making, and how patients' decisions may change over time; and 2) the impact of invasiveness on patients' perceptions of control on individually meaningful metrics (i.e., control of valued functional goals, control of valued personality characteristics, and global control). Our proposed study directly addresses the RFA-MH-19-400 goal to “empirically consider different perspectives on the distinction between invasive versus noninvasive … neuromodulation; particularly as those views are similar or different between groups”.

NARRATIVE Invasiveness is often assumed to entail increased risk of harm and reduced control. This study will rely on patients with essential tremor who undergo either deep brain stimulation (invasive surgery) or focused ultrasound (non-invasive surgery) to treat their tremors. We will conduct a systematic assessment of differences in expert physician and patient understanding of invasiveness, how those considerations influence patient decision-making and may change over time, and if invasive surgery results in different scores on measures of control that are personally meaningful compared to non-invasive surgery.