Inferior thalamic peduncle deep brain stimulation for treatment-refractory obsessive-compulsive disorder: A phase 1 pilot trial

Inferior thalamic peduncle deep brain stimulation for treatment-refractory obsessive-compulsive disorder: A phase 1 pilot trial
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DOI:
10.1016/j.brs.2018.11.012
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发表时间:
2019-03-01
期刊:
影响因子:
7.7
通讯作者:
Lozano, Andres M.
Lozano, Andres M.
中科院分区:
医学1区
文献类型:
--
作者:
Lee, Darrin J.;Dallapiazza, Robert F.;Lozano, Andres M.

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背景:针对边缘回路的几种不同的外科手术已被用于治疗严重的难治性强迫症;然而,对丘脑下脚(ITP)的研究非常有限。本研究的目的是确定ITP脑深部刺激(DBS)对重度强迫症患者的安全性和初步疗效。方法:重度难治性强迫症患者被纳入这项开放标签的1期DBS试点研究。双侧ITP DBS装置于2010年11月至2015年12月植入。主要结果是安全性。最初的疗效由耶鲁-布朗强迫症量表(YBOCs)评分确定。Y-BOCs成分评分、汉密尔顿抑郁严重程度量表、生活质量评估(SF-36)、牛津幸福问卷、沃里克-爱丁堡心理健康量表和Sheehan残疾量表也在术后至少2年内进行分析。此外,对2例患者进行术前和术后3个月的FDG-PET检查。结果:5例患者接受ITP DBS治疗,男2例,女3例,年龄25 ~ 48岁。所有5例患者在一年时(与基线相比,YBOCs评分改善52%(范围39 -73%,p < 0.01)和最后一次随访时(改善54%,范围38-85%,p < 0.01)均被认为有反应。在两年的随访中,两名患者发生了三次不良事件。一名患者在使用DBS系统一年后,因为该设备成为他的困扰对象而将其移除。另外两个不良事件与设备无关。2例患者术后FDG-PET成像显示右侧尾状核、右侧壳核、右侧辅助运动区和右侧扣带的葡萄糖摄取减少,双侧运动区、左侧颞极和左侧眶额皮质的葡萄糖摄取增加。结论:ITP DBS具有良好的安全性,可能是治疗严重强迫症的有效方法。需要更大规模的临床试验来确定疗效。(C) 2018爱思唯尔公司版权所有。
Background: Several different surgical procedures targeting the limbic circuit have been utilized for severe, treatment resistant obsessive-compulsive disorder; however, there has only been limited exploration of the inferior thalamic peduncle (ITP). The aim of this study was to determine the safety and initial efficacy of ITP deep brain stimulation (DBS) in patients with severe obsessive-compulsive disorder.Methods: Patients with severe, treatment-refractory obsessive-compulsive disorder were enrolled into this open-label phase 1 DBS pilot study. Bilateral ITP DBS devices were implanted between November 2010 and December 2015. The primary outcome was safety. The initial efficacy was determined by Yale-Brown Obsessive-Compulsive scale (YBOCs) scores. Component Y-BOCs scores, Hamilton Depression Severity Scale, Quality of Life Assessment (SF-36), Oxford Happiness Questionnaire, Warwick-Edinburgh Mental Well-Being Scale, and Sheehan Disability Scale were also analyzed for a minimum of 2 years after surgery. Additionally, preoperative and three-month postoperative FDG-PET studies were performed on two patients.Results: Five patients (2 males, 3 females; age range 25-48 years) received ITP DBS. All five patients were considered responders at one year (52% improvement in YBOCs scores compared to baseline (range 39 -73%, p < 0.01) and last follow-up (54% improvement; range 38-85%; p < 0.01). At two years follow-up, there were three adverse events that occurred in two patients. One patient had his DBS system removed after one year due to the device becoming the object of his obsession. The other two adverse events were not related to the device. Post-operative FDG-PET imaging in two patients demonstrated decreased glucose uptake within the right caudate, right putamen, right supplementary motor area, and right cingulum and increased glucose uptake in bilateral motor areas, left temporal pole, and left orbitfrontal cortex.Conclusions: ITP DBS has a favorable safety profile and is potentially an efficacious treatment for severe obsessive-compulsive disorder. Larger clinical trials are necessary to determine efficacy. (C) 2018 Elsevier Inc. All rights reserved.