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Comparison of DBS Targets in Obsessive-compulsive Disorder (PRESTOC2)

2016年5月17日 更新者:Assistance Publique - Hôpitaux de Paris

Comparison of the Efficacy of Subthalamic Nucleus, Caudate Nucleus and Nucleus Accumbens Electric Stimulation in Severe and Resistant Obsessive-compulsive Disorder.

Deep brain stimulation (DBS) has been proposed for severe and resistant obsessive-compulsive disorder. This electrical stimulation has been tested on, and shown to be effective at, different targets (subthalamic nucleus, caudate nucleus & nucleus accumbens). However, the efficacies of each target have never been compared directly.

This protocol aims to do so, with the hypothesis that subthalamic (STN) stimulation will be more efficacious.

研究概览

地位

完全的

条件

详细说明

Deep brain stimulation has been proposed for severe and resistant obsessive-compulsive disorder (OCD). This electrical stimulation has been tested on, and shown to be effective at, different targets (subthalamic nucleus, caudate nucleus & nucleus accumbens). However, the efficacies of each target have never been compared directly.

Therefore, bilateral subthalamic and caudate electrodes will be implanted in severe OCD patients. Efficacy of stimulation at the different targets will be assessed using a double-blind randomised crossover design.

研究类型

介入性

注册 (实际的)

8

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Paris、法国、75013
        • Centre d'investigation Clinique Pitié Salpêtrière

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 60年 (成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion criteria :

  • Age 18 - 60
  • OCD according to DSM IV, at least 5 years since diagnosis
  • Severe OCD responsible for a clinically significant and objective alteration of psychosocial functioning and suffering: YBOCS score>25, CGI score >= 4 and EGF score <= 40
  • Resistance of OCD to at least 3 antidepressants from the serotonin reuptake inhibitors category, including clomipramine, given for at least 12 weeks with doses of at least 80mg/d for fluoxetine, 300mg/d for fluvoxamine, 200mg/d for sertraline, 60mg/d for paroxetine and citalopram, 250mg/d for clomipramine). Plus resistance to each of these 3 antidepressant associated first to risperidone or pimozide for a month then to Lithium carbonate, clonazepam, buspirone or pindolol for a month
  • Resistance to at least 2 behavioural and cognitive therapies conducted by as many different specialists, following validated protocols (e.g. exposition and prevention of response)
  • Oral and written knowledge of French
  • Social security coverage
  • Written consent of the patient after clear description of the study

Exclusion criteria :

  • cognitive alteration with PM38 score < IQ85
  • Other axis 1 disorder according to DSM IV, excepted, global anxiety disorder, social phobia, nicotine dependance, and antecedent of major depressive episodes
  • suicidal risk >=2 on item 10 of MADRS (Montgomery Asberg Depression Rating Scale)
  • Personality disorder (axis 2 of DSM IV assessed using the SCID II)
  • Contra indication to MRI, abnormal brain MRI, other severe intercurrent disease
  • Fertile woman without adequate contraception
  • Pregnancy
  • Forced psychiatric hospitalisation
  • Any kind of legal protection

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的:Deep brain stimulation of subthalamic nucleus
Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.Stimulation of subthalamic nucleus
Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.
实验性的:Deep brain stimulation of caudate nucleus
Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker. Caudate nucleus stimulation
Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.
实验性的:Deep brain stimulation of nucleus accumbens
Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.Nucleus accumbens stimulation.
Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Severity of symptoms after each phase
大体时间:3 months
Severity as measured by the Yale-Brown Obsession and Compulsion scale
3 months

次要结果测量

结果测量
措施说明
大体时间
Severity of symptoms after each phase
大体时间:month 0
Severity as measured by the Yale-Brown Obsession and Compulsion scale
month 0
Severity of symptoms after each phase
大体时间:6 months
Severity as measured by the Yale-Brown Obsession and Compulsion scale
6 months
Severity of symptoms after each phase
大体时间:10 months
Severity as measured by the Yale-Brown Obsession and Compulsion scale
10 months
Severity of symptoms after each phase
大体时间:14 months
Severity as measured by the Yale-Brown Obsession and Compulsion scale
14 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Luc Mallet, MD, PhD、Assitance publique - Hôpitaux de Paris

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2010年10月1日

初级完成 (实际的)

2016年2月1日

研究完成 (实际的)

2016年2月1日

研究注册日期

首次提交

2013年1月25日

首先提交符合 QC 标准的

2013年3月6日

首次发布 (估计)

2013年3月8日

研究记录更新

最后更新发布 (估计)

2016年5月18日

上次提交的符合 QC 标准的更新

2016年5月17日

最后验证

2015年4月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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