Pilot Study of DBS for Treatment-Refractory OCD

DBS 治疗难治性强迫症的初步研究

• 批准号: 6918716
• 负责人: HERBERT E WARD
• 金额: $ 18.63万
• 依托单位: UNIVERSITY OF FLORIDA
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-08-21 至 2009-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6918716
• 关键词: brain electronic stimulator; clinical research; electrical conductance; electrodes; human subject; human therapy evaluation; implant; longitudinal human study; medical implant science; obsessive compulsive disorder; outcomes research; patient oriented research; quality of life

DESCRIPTION: (provided by applicant) This application is in response to PA-99- 134 for Exploratory/Development Grants for Mental Health Intervention Research. The long-term goal of this research project is to reduce symptom severity and enhance quality of life for patients with severe and intractable obsessive-compulsive disorder (OCD). Despite advances in the pharmacological and behavioral therapies for OCD, a substantial number of patients fail to improve significantly following years of conventional as well as experimental interventions. For some patients, stereotactic neurosurgery (either cingulotomy or anterior capsulotomy) is the only promising option left. The available evidence suggests that these procedures may lead to enduring benefits and relatively few side effects in the majority of OCD patients with intractable disease. However, the effects of these ablative techniques on brain tissue and function are irreversible. Recently, a team of European investigators reported in the Lancet positive results in three of four intractable cases of OCD using bilateral deep brain stimulation (DBS) of the anterior limb of the internal capsule. Independent confirmation by a qualified psychiatric-neurosurgical team is crucial before it gains more widespread use; there are already indications from the Internet that numerous centers across the country are pursuing it. On the surface, it seems appealing, at least in contrast to other neurosurgical alternatives. Although DBS, like ablative surgery, is an invasive procedure with infrequent but serious risks, unlike ablative techniques, DBS is adjustable and partially reversible. If it fails, the device can be turned off, the inactive electrodes are usually left in place, but no permanent alteration in neuronal function is likely. The current project is designed to gather preliminary data on the effectiveness, safety, and tolerability of chronic electrical stimulation (DBS) via bilaterally implanted electrodes in the anterior limb of the internal capsules of six cases of 'malignant' treatment-refractory OCD that would otherwise be candidates for ablative neurosurgery. They will be followed for two years post surgery. All candidates for this procedure will have to pass review by an interdisciplinary internal review panel as well as two independent external reviewers. If shown effective, DBS might replace ablative neurosurgery, but should still be considered the intervention of last resort in the most profoundly ill and intractable cases of OCD.

描述：(申请人提供)本申请是对PA-99的回应- 134精神健康干预研究探索性/发展补助金。 这项研究项目的长期目标是降低症状严重程度和 提高重症难治性心脏病患者的生活质量 强迫症(OCD)。尽管在药理方面取得了进展 和行为疗法治疗强迫症，相当多的患者未能 经过多年的常规和试验，显著改进 干预措施。对于一些患者，立体定向神经外科手术(要么是扣带回切开术 或前囊膜切开术)是唯一有希望的选择。可用的 有证据表明，这些程序可能会带来持久的好处和 大多数难治性强迫症患者的副作用相对较少 疾病。然而，这些消融技术对脑组织和 功能是不可逆转的。最近，一组欧洲调查人员报告说 在《柳叶刀》杂志上，四例难治性强迫症患者中有三例使用 双侧内侧前肢深部脑刺激(DBS) 太空舱。由合格的精神神经外科团队独立确认 在它得到更广泛的使用之前是至关重要的；已经有迹象表明 从互联网上，全国各地的许多中心都在追逐它。在……上面 表面上看，它似乎很吸引人，至少与其他神经外科手术相比是这样 另类选择。尽管像消融手术一样，DBS也是一种侵入性手术 与消融技术不同，DBS具有罕见但严重的风险， 可调且部分可逆。如果失败了，可以关闭该设备， 不活动的电极通常留在原地，但不会永久改变 在神经功能上是可能的。当前项目旨在收集 慢性前列腺炎的有效性、安全性和耐受性的初步数据 双侧脑内植入电极的电刺激(DBS) 恶性内囊前肢6例 治疗-难治性强迫症，否则将成为消融术的候选对象 神经外科。他们将在手术后接受为期两年的追踪。所有候选人 因为这个程序必须通过一个跨学科的内部审查 审查小组以及两名独立的外部审查员。如果证明是有效的， DBS可能会取代消融性神经外科手术，但仍应被视为 在最严重和最棘手的情况下，最后手段的干预 强迫症。