Controlled Trial of DBS for OCD

DBS 治疗强迫症的对照试验

• 批准号: 7145794
• 负责人: BENJAMIN D GREENBERG
• 金额: $ 83.23万
• 依托单位: BUTLER HOSPITAL (PROVIDENCE, RI)
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-25 至 2011-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7145794
• 关键词: behavioral /social science research tag; brain electronic stimulator; brain metabolism; clinical research; clinical trials; human subject; human therapy evaluation; major depression; medical rehabilitation related tag; neurosurgery; obsessive compulsive disorder; patient oriented research; personality; positron emission tomography; quality of life; questionnaires; therapy adverse effect

DESCRIPTION (provided by applicant): Treatment-resistant obsessive-compulsive disorder (OCD) remains a significant public health problem. Despite aggressive conventional treatment, suffering and functional impairment may continue, degrading quality of life. Our three collaborative pilot studies suggest that deep brain stimulation (DBS) of the ventral anterior limb of internal capsule and adjacent ventral striatum (VC/VS) is effective in otherwise resistant OCD. The devices (made by Medtronic, Inc.) are uniquely FDA-approved for brain stimulation, with proven efficacy and safety in Parkinson disease, tremor, and dystonia. In seven years of pilot OCD work, the brain target has been refined and effective DBS parameters identified. We propose a more definitive controlled trial. This collaborative, five-year study involves the three U.S. sites most experienced in DBS for OCD, including the NIMH pilot trial site. Forty-five patients will enroll in a randomized, parallel, controlled design. We will use well-established procedures to determine if patients are resistant to medication and behavior therapies. Independent assessments of diagnosis, treatment history, and the consent process will be required for enrollment. Patients will enroll, 11-12/year, over the first four years. We will compare masked active to sham stimulation over three months to obtain primary efficacy and safety data. The criterion for DBS response will be categorical and strict: improvement in both symptoms (a 35% Yale-Brown Obsessive- Compulsive Scale score reduction) and in global functioning. After the three-month controlled phase, open DBS will continue for 1-4 years to obtain long-term effectiveness and safety data. Positron emission tomography at baseline will be used to obtain brain metabolic predictors of response. A repeat scan after at least three months of stimulation will test the hypothesis that activity in corticobasal networks implicated in OCD will change after DBS. If successful, reversible DBS will offer hope to severely affected people with few treatment options. The imaging data will provide unique insight into brain networks predicting and mediating the response to DBS for intractable OCD.

描述（由申请人提供）：抗治疗的强迫症（OCD）仍然是一个重大的公共卫生问题。尽管进行了积极的常规治疗，但仍可能继续遭受痛苦和功能障碍，从而降低了生活质量。我们的三项协作试验研究表明，内部囊和邻近腹侧纹状体（VC/VS）的腹侧前肢的深脑刺激（DB）有效地有效。这些设备（由Medtronic，Inc。制造）是由FDA批准的，用于脑刺激，并具有可靠的疗效和安全性在帕金森氏病，震颤和肌张力障碍中。在七年的试验性强迫症工作中，大脑目标已被完善并确定有效的DBS参数。我们提出了更确定的对照试验。这项合作五年的研究涉及OCD中最多经验的美国三个美国网站，包括NIMH试点试验地点。四十五名患者将参加随机，平行，受控的设计。我们将使用良好的程序来确定患者是否对药物和行为疗法有抵抗力。诊断，治疗病史和同意过程的独立评估将需要入学。在头四年中，患者将入学为11-12/年。我们将在三个月内将蒙面的活动与假刺激进行比较，以获得一级功效和安全性数据。 DBS响应的标准将是分类和严格的：两种症状的改善（耶鲁棕色的强迫性量表得分降低）和全球功能。在三个月的受控阶段之后，开放DBS将持续1 - 4年，以获得长期有效性和安全性数据。基线时正电子发射断层扫描将用于获得脑反应的代谢预测指标。至少三个月的刺激后进行重复扫描将检验以下假设：与OCD有关的皮质肥大网络的活性在DBS之后会发生变化。如果成功，可逆的DBS将为严重影响的人提供希望的希望。成像数据将为大脑网络提供独特的见解，以预测和介导对DBS的反应，以实现棘手的强迫症。