Deep Brain Stimulation for Disorders of Mood Thought and Behavior: Scientific an

深部脑刺激治疗情绪、思想和行为障碍：科学和

• 批准号: 7334611
• 负责人: DEBRA JH MATHEWS
• 金额: $ 4.96万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-08-01 至 2009-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7334611
• 关键词: Behavior; Brain; Chest; Clinical Trials Design; Conduct Clinical Trials; Consensus; Deep Brain Stimulation; Development; Disease; Ethical Issues; Exclusion Criteria; Fostering; Gilles de la Tourette syndrome; Implant; Implanted Electrodes; Informed Consent; Manic; Mental Depression; Mood Disorders; Motor; Movement Disorders; Obsessive-Compulsive Disorder; Parkinson Disease; Pharmacological Treatment; Physiologic pulse; Privacy; Procedures; Pulse taking; Randomized Controlled Trials; Reporting; Research; Research Personnel; Resistance; Science; Staging; Standards of Weights and Measures; Symptoms; Technology; Thinking; design; human subject; symposium

DESCRIPTION (provided by applicant): In the last decade, the treatment of Parkinson disease and other movement disorders has been revolutionized by the advent of deep brain stimulation (DBS), a procedure in which electrodes are implanted into the brain and a constant electrical current is applied via a pulse generator implanted in the chest. In addition to alleviation of motor symptoms, DBS has been known to produce psychiatric effects, including transient depression, mania, and alleviation of obsessive- compulsive symptoms. In part due to these observed effects, in concert with the lack of other effective treatments, DBS has been proposed as a therapy for treatment-resistant depression (TRD), obsessive-compulsive disorder (OCD) and Tourette syndrome. Preliminary reports have suggested that DBS may be effective for such disorders, and there are currently several research teams exploring DBS for the treatment of disorders of mood, thought and behavior. We propose to convene a small professional conference to explore scientific and ethical issues related to the design and conduct of clinical trials of DBS for disorders of mood, thought and behavior, while such research is still in its formative stages. The specific aims of this meeting are: 1. To explore the extent to which the use of DBS for the treatment of disorders of mood, thought and behavior is similar to and different from pharmacological treatment for such disorders, and if different, what ethical challenges are unique to DBS in this context; 2. To establish consensus among researchers about the design of clinical trials of DBS for disorders of mood, thought and behavior, including inclusion/exclusion criteria and whether randomized, controlled trials should be required; 3. To develop standards for the protection of human subjects who participate in such studies, given their potentially diminished capacity to provide valid informed consent. DEEP BRAIN STIMULATION FOR DISORDERS OF MOOD, THOUGHT AND BEHAVIOR: SCIENTIFIC AND ETHICAL ISSUES This project is designed to foster and facilitate discussions and deliberations of the scientific and ethical issues raised by the use of deep brain stimulation for disorders of mood, thought and behavior early in the development of the science. Such a proactive approach to emerging treatments and technologies benefits the public by forestalling potential ethical problems related to, for example, informed consent, inclusion/exclusion criteria and privacy.

描述（由申请人提供）：在过去的十年中，帕金森病和其他运动障碍的治疗因脑深部电刺激（DBS）的出现而发生了革命性变化，脑深部电刺激是一种将电极植入大脑并通过植入胸部的脉冲发生器施加恒定电流的手术。除了缓解运动症状外，已知DBS还产生精神影响，包括短暂性抑郁、躁狂和缓解强迫症状。部分由于这些观察到的效果，以及缺乏其他有效的治疗方法，DBS已被提议作为难治性抑郁症（TRD）、强迫症（OCD）和抽动秽语综合征的治疗方法。初步报告表明，DBS可能对此类疾病有效，目前有几个研究小组正在探索DBS用于治疗情绪、思想和行为障碍。我们建议召开一个小型的专业会议，探讨与DBS治疗情绪、思维和行为障碍的临床试验的设计和实施相关的科学和伦理问题，而此类研究仍处于形成阶段。本次会议的具体目标是：1.探讨使用DBS治疗情绪、思想和行为障碍与药物治疗此类疾病的相似和不同程度，如果不同，DBS在此背景下独特的伦理挑战; 2.在研究者中就DBS治疗情绪、思维和行为障碍的临床试验设计达成共识，包括纳入/排除标准以及是否需要随机对照试验; 3.鉴于参与此类研究的人类受试者提供有效知情同意的能力可能降低，制定保护这些受试者的标准。脑深部电刺激治疗情绪、思想和行为障碍：科学和伦理问题本项目旨在促进和促进对在科学发展早期使用脑深部电刺激治疗情绪、思想和行为障碍所引起的科学和伦理问题的讨论和审议。对新出现的治疗方法和技术采取这种积极主动的做法，可以预防与知情同意、纳入/排除标准和隐私等有关的潜在道德问题，从而使公众受益。