Neuroethics of aDBS Systems Targeting Neuropsychiatric and Movement Disorders

针对神经精神和运动障碍的 aDBS 系统的神经伦理学

• 批准号: 10002034
• 负责人: Wayne K Goodman
• 金额: $ 51.91万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-15 至 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10002034
• 关键词: Address; Affective; Anxiety; Area; BRAIN initiative; Bioethics; Biomedical Technology; Brain; Caregivers; Categories; Clinical; Clinical Management; Clinical Research; Clinical Trials; Cohort Studies; Data; Deep Brain Stimulation; Dehumanization; Development; Devices; Disease; Essential Tremor; Ethics; Funding; Gilles de la Tourette syndrome; Goals; Individual; Interview; Investments; Medicine; Mental Depression; Monitor; Moods; Motor output; Movement Disorders; Normalcy; Obsessive-Compulsive Disorder; Operative Surgical Procedures; Ownership; Parkinson Disease; Participant; Patients; Perception; Policies; Policy Research; Privacy; Questionnaires; Research; Research Personnel; Resistance; Risk; Running; Structure; System; Time; Translating; Translations; United States; United States National Institutes of Health; Work; clinical care; cohort; college; ethical legal social implication; experience; improved; informant; innovation; neuroethics; neuropsychiatric disorder; neuroregulation; neurotechnology; new technology; novel; policy implication; programs; relating to nervous system; side effect; social; uptake; willingness

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.

项目概要 自适应深部脑刺激（aDBS）系统可以记录神经活动并实时调整刺激 这些系统已成为解决传统技术的重大局限性的有前途的替代方案。 大脑计划 (BRAIN Initiative) 等开展了开环 DBS 治疗神经精神和运动障碍的研究。 然而，在研究上投入了大量资金以加速 aDBS 的发展。 使用可以改变情绪或运动输出的 DBS，引起了许多伦理、法律和社会（“神经伦理学”） 担忧（例如非人性化、对自治/代理的威胁、个人身份的变化）。 可能会加剧这些担忧并引发新的神经伦理问题（例如，隐私、使用和所有权） 尽管理论生物伦理学工作已经探索了传统开环的伦理影响。 DBS用于治疗各种疾病，这方面的实证神经伦理学研究很少，并且有 关于 aDBS 的神经伦理学研究严重缺乏，这些问题需要进行实证检验和研究。 致力于负责任地研究并将 aDBS 转化为临床护理。 我们研究计划的长期目标是开发一种道德合理、经验丰富的方法 aDBS 系统负责任的研究和翻译的政策框架 本提案的目标， 这是实现这一目标的第一步，是确定与 aDBS 相关的最紧迫的神经伦理问题 从多个临床研究的不同利益相关者的角度进行研究和翻译 本研究将实证检验与研究和翻译相关的神经伦理学挑战。 我们将研究这些神经伦理学。 通过以下方式解决问题：1) 对开展 BRAIN 资助的 aDBS 临床试验的研究人员进行参与观察 强迫症 (OCD)，以及 2) 与利益相关者进行深入的半结构化访谈（即 aDBS 研究人员、研究拒绝者、患者参与者和护理人员）参与了五项不同的 aDBS 临床试验。 我们还将 3) 检查 aDBS 系统是否以及如何影响患者参与者的自主性认知， 个人身份，以及通过在 aDBS 手术前后进行经过验证的管理来承担风险的意愿 问卷并在与患者参与者的半结构化访谈中探讨这些问题。 识别和理解 aDBS 神经伦理问题可以帮助制定管理计划，以促进 负责任地研究和翻译 aDBS，并最大限度地提高 aDBS 的社会效用。 安全有效，最大限度地减少紧迫的神经伦理学挑战将有助于人们接受这一点 神经技术使数十万可以从这些系统中受益的人受益。