PROJECT SUMMARY Adaptive deep brain stimulation (aDBS) systems can record neural activity and adjust stimulation in real time. These systems have emerged as a promising alternative to address significant limitations in conventional open-loop DBS treatment of neuropsychiatric and movement disorders. The BRAIN Initiative and others have made substantial investments in studies to accelerate the development of aDBS. However, neuromodulation using DBS that can alter mood or motor outputs, has raised numerous ethical, legal, and social (“neuroethics”) concerns (e.g., dehumanization, threats to autonomy/agency, changes in personal identity). aDBS systems may exacerbate these concerns and raise novel neuroethics issues (e.g., privacy, use, and ownership of neural data). Although theoretical bioethics work has explored ethical implications of conventional open-loop DBS for treating various disorders, there is little empirical neuroethics research in this area, and there is a severe lack of neuroethics research about aDBS. These issues need to be empirically examined and addressed to responsibly research and translate aDBS to clinical care. The long term goal of our research program is to develop an ethically-justified and empirically-informed policy framework for the responsible research and translation of aDBS systems. The objective of this proposal, which is the first step in pursuit of that goal, is to identify the most pressing neuroethics issues related to aDBS research and translation from the perspective of diverse stakeholders across multiple clinical research contexts. This study will empirically examine neuroethics challenges associated with research and translation of aDBS systems for treating neuropsychiatric and movement disorders. We will examine these neuroethics issues by conducting: 1) participant observation of researchers running a BRAIN-funded aDBS clinical trial for obsessive compulsive disorder (OCD), and 2) in-depth semi-structured interviews with stakeholders (i.e., aDBS researchers, study decliners, patient-participants, and caregivers) involved in five different aDBS clinical trials. We will also 3) examine if, and how, aDBS systems impact patient-participants’ perceptions of autonomy, personal identity, and willingness to take risks by administering validated pre- and post-aDBS surgery questionnaires and exploring these issues during the semi-structured interviews with patient-participants. Identifying and understanding aDBS neuroethics issues can help develop management plans to promote the responsible research and translation of aDBS, and maximize its social utility. If aDBS is eventually considered safe and effective, minimizing pressing neuroethics challenges will contribute to the uptake of this neurotechnology among the hundreds of thousands who could benefit from these systems.

PROJECT NARRATIVE Adaptive deep brain stimulation (aDBS) systems can record neural activity and adjust brain stimulation in real time, and have emerged as a promising alternative to address significant limitations in conventional open- loop DBS treatment of the hundreds of thousands of individuals in the United States who suffer from treatment- resistant neuropsychiatric and movement disorders. However, neuromodulation using deep brain stimulation that can alter mood or motor outputs, has raised numerous ethical, legal, and social (“neuroethics”) concerns (e.g., dehumanization, changes in personal identity, threats to autonomy/agency), and aDBS systems may exacerbate these concerns and raise novel neuroethics issues (e.g., privacy, use, and ownership of neural data). This study will promote the responsible research and translation of aDBS systems by empirically identifying and examining neuroethics issues raised by aDBS with researchers, patient-participants, their caregivers, and study decliners involved in ongoing aDBS clinical trials.