Comparison of DBS Targets in Obsessive-compulsive Disorder (PRESTOC2)
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
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
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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Paris、法国、75013
- Centre d'investigation Clinique Pitié Salpêtrière
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
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
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 |
|---|---|
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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
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Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.
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实验性的:Deep brain stimulation of caudate nucleus
Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.
Caudate nucleus stimulation
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Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.
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实验性的:Deep brain stimulation of nucleus accumbens
Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.Nucleus accumbens stimulation.
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Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.
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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 |
|---|---|---|
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Severity of symptoms after each phase
大体时间:3 months
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Severity as measured by the Yale-Brown Obsession and Compulsion scale
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3 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Severity of symptoms after each phase
大体时间:month 0
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Severity as measured by the Yale-Brown Obsession and Compulsion scale
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month 0
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Severity of symptoms after each phase
大体时间:6 months
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Severity as measured by the Yale-Brown Obsession and Compulsion scale
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6 months
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Severity of symptoms after each phase
大体时间:10 months
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Severity as measured by the Yale-Brown Obsession and Compulsion scale
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10 months
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Severity of symptoms after each phase
大体时间:14 months
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Severity as measured by the Yale-Brown Obsession and Compulsion scale
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14 months
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合作者和调查者
调查人员
- 首席研究员:Luc Mallet, MD, PhD、Assitance publique - Hôpitaux de Paris
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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