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.

项目摘要 自适应脑深部电刺激（aDBS）系统可以记录神经活动并在真实的环境中调整刺激 时间这些系统已经成为解决常规系统中的重大限制的有希望的替代方案。 神经精神和运动障碍的开环DBS治疗。BRAIN Initiative和其他组织 在研究方面进行了大量投资，以加速aDBS的发展。然而，神经调节 使用DBS可以改变情绪或运动输出，已经提出了许多伦理，法律的和社会（“神经伦理学”） 关注点（例如，非人化、对自主/能动性的威胁、个人身份的改变）。aDBS系统 可能加剧这些担忧并引起新的神经伦理学问题（例如，隐私、使用和所有权 神经数据）。虽然理论生物伦理学工作已经探讨了传统开环 DBS用于治疗各种疾病，在这一领域几乎没有经验主义的神经伦理学研究， 严重缺乏关于aDBS的神经伦理学研究。这些问题需要进行实证研究， 致力于负责任地研究并将aDBS转化为临床护理。 我们的研究计划的长期目标是发展一个道德上合理和道德上知情的 负责aDBS系统的研究和翻译的政策框架。这项建议的目的， 这是追求这一目标的第一步，是确定与aDBS相关的最紧迫的神经伦理学问题 从跨多个临床研究的不同利益相关者的角度进行研究和翻译 contexts.本研究将实证检验与研究和翻译相关的神经伦理学挑战 用于治疗神经精神和运动障碍的aDBS系统。我们将研究这些神经伦理学 通过进行以下活动来解决问题：1）参与者观察研究人员进行BRAIN资助的aDBS临床试验， 强迫症（OCD），和2）与利益相关者的深度半结构化访谈（即，aDBS 研究人员、研究下降者、患者参与者和护理人员）参与了五项不同的aDBS临床试验。 我们还将检查aDBS系统是否以及如何影响患者参与者对自主性的看法， 个人身份，并愿意通过实施经验证的aDBS手术前后来承担风险 问卷调查，并探讨这些问题在半结构化的访谈与病人的参与者。 识别和理解aDBS神经伦理学问题有助于制定管理计划， 负责任地研究和翻译aDBS，并最大限度地发挥其社会效用。如果最终考虑使用aDBS 安全和有效，最大限度地减少紧迫的神经伦理学挑战将有助于吸收这一点， 神经技术，成千上万的人可以从这些系统中受益。