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，帕金森氏病和其他运动障碍的治疗已通过深脑刺激（DBS）的出现进行了革新，该程序将电极植入大脑中，并通过植入胸部植入的脉冲发生器应用恒定的电流。除了缓解运动症状外，DBS还众所周知，还会产生精神病，包括短暂性抑郁症，躁狂和缓解强迫性症状。部分原因是这些观察到的影响，与缺乏其他有效治疗的一致性，DBS被提议作为一种耐治疗抑郁症（TRD），强迫症（OCD）和Tourette综合征的治疗疗法。初步报告表明，DBS可能对此类疾病有效，目前有几个研究团队探索DBS治疗情绪，思想和行为障碍。我们建议召集一次小型专业会议，以探讨与DBS的临床试验有关情绪，思想和行为障碍的临床试验有关的科学和道德问题，而此类研究仍处于形成阶段。这次会议的具体目的是：1。探索DBS在情绪，思想和行为障碍治疗的程度与此类疾病的药理学治疗相似，并且在这种情况下，DBS独有的道德挑战是相似的； 2。在研究人员之间就情绪，思想和行为障碍的DBS临床试验设计建立共识，包括纳入/排除标准以及是否需要随机，对照试验； 3。为了制定保护参与此类研究的人类受试者的标准，鉴于他们提供有效知情同意的能力可能会降低。对情绪，思想和行为障碍的深刻刺激：科学和道德问题该项目旨在促进和促进讨论和审议，从而在科学发展的早期使用深层大脑刺激对情绪，思想和行为的疾病而提出的科学和道德问题。这种积极主动的方法用于新兴治疗和技术，通过阻止与知情同意，包容/排除标准和隐私相关的潜在道德问题，使公众受益。