NCT02377375招募中不适用
Deep Brain Stimulation (DBS) for Obsessive Compulsive Disorder (OCD) in the Bed Nucleus of the Stria Terminalis (BNST): Improving Targeting Precision
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Millimeter difference in position between planned and actual target
研究概览
简要总结
When comparing targeting precision between DBS in parkinsonian patients and OCD patients, an unexpected deviation from the planned targets was discovered in OCD patients (Nuttin et al., 2013). The objective of this trial is to investigate whether the use of a micro-electrode assisted technique improves targeting precision in DBS at the BNST.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of OCD following the diagnostic and statistical manual of mental disorders-fourth edition (DSM-IV) criteria for OCD (300.3).
- •Failure of documented trials of pharmacotherapy, following an appropriate treatment algorithm for OCD.
- •Failure of documented trial of cognitive and behavioural therapy
- •Duration of illness: min. 5 year
- •Y-BOCS (Yale-Brown Obsessive Compulsive Scale) at least 30/
- •Age: 20-65 year
排除标准
- •DSM-IV diagnosis on axis 2 of severe personality disorder in cluster A or B, especially in the case of heightened risk for acting-out behavior.
- •DSM-IV diagnosis on axis 3 of organic brain pathology or significant abnormalities on MRI.
- •Present or past history of psychotic symptoms.
- •Present substance abuse, or instable remission of substance abuses (i.e. no substance abuse during the last 12 months).
- •Any disorder affecting cognitive functioning, other than motor tics and Gilles de la Tourette's Syndrome
- •Mental retardation. A minimum threshold of cognitive skills is needed for adequate reporting on questionnaires and evaluation, and for technical handling of the instruments in a later faze.
结局指标
主要结局
Millimeter difference in position between planned and actual target
时间窗: 4 weeks after surgery
次要结局
未报告次要终点
研究者
研究点 (2)
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