Subthalamic Nucleus Stimulation in Severe Obsessive-Compulsive Disorder

Subthalamic Nucleus Stimulation in Severe Obsessive-Compulsive Disorder
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DOI:
10.1056/nejmoa0708514
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发表时间:
2008-11-13
影响因子:
158.5
通讯作者:
Pelissolo, Antoine
Pelissolo, Antoine
中科院分区:
医学1区
文献类型:
--
作者:
Mallet, Luc;Polosan, Mircea;Pelissolo, Antoine

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背景:严重、难治性强迫症(OCD)是一种致残状态。丘脑底核刺激是一种治疗运动障碍的有效方法。方法:在这项为期10个月、交叉、双盲、多中心的研究中,我们随机将8名高度难治性强迫症患者分为两组,分别接受丘脑底核主动刺激和假刺激,以及8名患者接受假刺激和主动刺激。主要的结果衡量标准是强迫症的严重程度,用耶鲁-布朗强迫量表(Y-BOCS)在两个3个月的疗程结束时进行评估。结果:主动刺激丘脑底核后,Y-BOCS评分(评分0~40分,评分较低者症状较轻)显著低于假刺激后(平均[+/-SD],19+/-8分对28+/-7分);GAF值(从1到90,分数越高,表明功能水平越高)明显更高(56+/-14比43+/-8,P=0.005)。神经心理测量、抑郁和焦虑的评分不受刺激的影响。共有15例严重不良事件,包括1例脑出血和2例感染;23例非严重不良事件。结论:这些初步研究结果提示,刺激丘脑底核可以减轻严重形式的强迫症的症状,但与严重不良事件的风险很大。(ClinicalTrials.gov编号,NCT00169377)。
Background: Severe, refractory obsessive-compulsive disorder (OCD) is a disabling condition. Stimulation of the subthalamic nucleus, a procedure that is already validated for the treatment of movement disorders, has been proposed as a therapeutic option.Methods: In this 10-month, crossover, double-blind, multicenter study assessing the efficacy and safety of stimulation of the subthalamic nucleus, we randomly assigned eight patients with highly refractory OCD to undergo active stimulation of the subthalamic nucleus followed by sham stimulation and eight to undergo sham stimulation followed by active stimulation. The primary outcome measure was the severity of OCD, as assessed by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS), at the end of two 3-month periods. General psychopathologic findings, functioning, and tolerance were assessed with the use of standardized psychiatric scales, the Global Assessment of Functioning (GAF) scale, and neuropsychological tests.Results: After active stimulation of the subthalamic nucleus, the Y-BOCS score (on a scale from 0 to 40, with lower scores indicating less severe symptoms) was significantly lower than the score after sham stimulation (mean [+/-SD], 19+/-8 vs. 28+/-7; P=0.01), and the GAF score (on a scale from 1 to 90, with higher scores indicating higher levels of functioning) was significantly higher (56+/-14 vs. 43+/-8, P=0.005). The ratings of neuropsychological measures, depression, and anxiety were not modified by stimulation. There were 15 serious adverse events overall, including 1 intracerebral hemorrhage and 2 infections; there were also 23 nonserious adverse events.Conclusions: These preliminary findings suggest that stimulation of the subthalamic nucleus may reduce the symptoms of severe forms of OCD but is associated with a substantial risk of serious adverse events. (ClinicalTrials.gov number, NCT00169377.).