Ethics of Control and Consent in Brain Stimulation for Parkinson Disease

帕金森病脑刺激的控制和同意伦理

• 批准号: 7933763
• 负责人: Paul Jason Ford
• 金额: $ 41.95万
• 依托单位: CLEVELAND CLINIC LERNER COM-CWRU
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2012-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7933763
• 关键词: Address; Affect; Area; Behavior; Bioethics; Brain; Cognitive; Consent; Data; Deep Brain Stimulation; Devices; Disease; Electrodes; Elements; Emerging Technologies; Ensure; Ethical Issues; Ethics; Feeling; Freedom; Fright; Glean; Goals; Individual; Informed Consent; Interview; Liquid substance; Measures; Medicine; Metric; Movement; Nature; Operative Surgical Procedures; Parkinson Disease; Participant; Patients; Persons; Postoperative Period; Process; Role; Structure; Symptoms; Thinking; Time; Tremor; design; improved; interest; neuropsychiatry; neuroregulation; outer surface lipoprotein; psychologic; symptom management

DESCRIPTION (provided by applicant): This application addresses broad Challenge Area (02): Bioethics and specific Challenge Topic 02- OD(OSP)-101: Unique Ethical Issues Posed by Emerging Technologies. The current study examines the ethical challenges inherent in participants' considerations of control using Deep Brain Stimulation (DBS) for the treatment of Parkinson disease (PD) as a paradigm. Many historical and fictional stories have promulgated fears that brain stimulators necessarily impede a person's liberty and autonomy, particularly with respect to control. However, these stories offer only simple imaginative explorations that fail to engage the more important ethical challenges faced in the realities of contemporary medicine. A fundamental ethical tenet in medicine is to maximize and respect an individual's retention of bodily sovereignty, inherent in which is the concept of control. Three types of control are particularly important: symptom control, device control, and personal control. Symptom control refers to one's ability to alter disease symptoms, such as tremor. Device control refers to one's ability to adjust the actual stimulator settings. Personal control refers to one's ability to autonomously and volitionally act to achieve personal goals. Personal control is highly individualized and value laden which makes it ethically interesting and central to informed consent. Improvements in symptom control or stimulator control may not match improvements in personal control. In order to provide better informed consent it is important to recognize the challenges inherent in the shifting nature of personal control that occur before and after DBS therapy. We hypothesize that patients' goals for DBS include symptom, device and personal control elements with overarching goals related to increases in personal control over specific personal functions. The study employs a repeated measures design in which 50 participants with Parkinson Disease who are undergoing DBS will rate and rank symptom management and personal control with respect to specific individually tailored behaviors compared prior to surgery and at two time points following surgery (3 months and 6 months post-operative). We will also examine the role of potential cognitive and psychological variables in moderating changes in considerations of control following surgery. In addition to the quantitative measures, qualitative data gleaned from semi-structured interviews will assess themes in participants' values of control with respect to specific objectives. Deep Brain Stimulation may affect people's liberty and autonomy, particularly their control over bodily movements, thoughts, and feelings. The proposed study will provide data to improve the informed consent process that includes consideration of the fluid nature of participants' values. This study will also provide data to identify participants who require increased educational efforts in order to ensure informed consent. The current study examines the ethical challenges inherent in participants' considerations of control in the context of consent for Deep Brain Stimulation (DBS). These data will improve the informed consent process through careful deliberation of the fluid nature of participants' values related to personal control. This study will also provide data to identify participants who require increased educational efforts in order to ensure informed consent.

描述（由申请人提供）：本申请涉及广泛的挑战领域（02）：生物伦理学和特定的挑战主题02- OD（OSP）-101：新兴技术带来的独特伦理问题。目前的研究探讨了参与者使用脑深部电刺激（DBS）治疗帕金森病（PD）作为范例的控制考虑中固有的伦理挑战。许多历史和虚构的故事都宣扬了这样一种恐惧，即大脑刺激器必然会阻碍一个人的自由和自主权，特别是在控制方面。然而，这些故事只提供了简单的富有想象力的探索，未能参与当代医学现实中面临的更重要的伦理挑战。医学中的一个基本伦理原则是最大限度地尊重个人对身体主权的保留，其中固有的是控制的概念。三种类型的控制特别重要：症状控制、设备控制和个人控制。症状控制是指一个人改变疾病症状的能力，如震颤。器械控制是指调整实际刺激器设置的能力。个人控制指的是一个人自主和意志行动以实现个人目标的能力。个人控制是高度个性化和价值负载，这使得它在伦理上有趣和知情同意的核心。症状控制或刺激器控制的改善可能与个人控制的改善不匹配。为了提供更好的知情同意，重要的是要认识到DBS治疗前后发生的个人控制的变化性质所固有的挑战。我们假设患者DBS的目标包括症状、器械和个人控制要素，总体目标与增加对特定个人功能的个人控制相关。该研究采用了重复测量设计，其中50名接受DBS的帕金森病参与者将在手术前和手术后两个时间点（术后3个月和6个月）对症状管理和个人控制进行评分和排名，并与特定的个性化行为进行比较。我们还将研究潜在的认知和心理变量在调节手术后控制因素变化中的作用。除了定量措施外，从半结构化访谈中收集的定性数据将评估参与者对具体目标的控制价值观中的主题。脑深部电刺激可能会影响人们的自由和自主性，特别是他们对身体运动，思想和感觉的控制。拟议的研究将提供数据，以改善知情同意过程，包括考虑参与者价值观的流动性。本研究还将提供数据，以确定需要加强教育以确保知情同意的受试者。目前的研究探讨了参与者在同意脑深部电刺激（DBS）的背景下考虑控制所固有的伦理挑战。这些数据将通过仔细考虑参与者与个人控制有关的价值观的流动性来改善知情同意过程。本研究还将提供数据，以确定需要加强教育以确保知情同意的受试者。