NCT04228744Unknown不适用
Deep Brain Stimulation for Refractory Obsessive-Compulsive Disorder: Efficacy and Mechanism of Ventral Internal Capsue and Nucleus Accumbens
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) score
研究概览
简要总结
This study will evaluate the efficacy and explore the mechanism of deep brain stimulation (DBS) in the ventral internal capsule (VIC) and nucleus accumbens (NAc) for refractory obsessive-compulsive disorder (OCD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 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 with duration of at least 5 years;
- •Severity rated as severe to extreme illness;
- •Failed adequate trial of at least three specific serotonin reuptake inhibitor (SSRI) antidepressants;
- •Failed augmentation with antipsychotic;
- •Completed or failed to complete adequate trial of cognitive behavioural therapy for OCD;
- •Stable medication regimen for one month before surgery;
- •Signed informed consent;
排除标准
- •Hoarding as a primary symptom;
- •No other serious psychiatric disorder such as psychotic disorder;
- •Drug or substance use disorder within 6 months except nicotine;
- •Major Neurological/Medical condition;
- •High suicide risk;
- •Pregnancy or lactation;
- •Contraindications to stereotactic surgery;
- •Contraindications to MRI;
研究组 & 干预措施
Bilateral surgical implantation of DBS system
Experimental
All the participants will receive bilateral surgical implantation of DBS system to VIC and NAc. The experimenter will active the DBS system and adjust the parameters for all the participants after surgery.
干预措施: DBS system (Device)
结局指标
主要结局
Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) score
时间窗: Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months
Y-BOCS is used to rate the severity of OCD symptoms by clinicians. Higher score means more severe OCD symptoms.
次要结局
- Change in memory(Baseline (preoperative),6 months or 12 months)
- Changes in PSQI score(Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months)
- Adverse Events(Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months)
- Change in Yale-Brown Obsessive-Compulsive Scale-Self Report (Y-BOCS-SR) Score(Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months)
- Change in Yale-Brown Obsessive-Compulsive Scale-Second Edition (Y-BOCS-II) Score(Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months)
- Change in Obsessive-Compulsive Inventory - Revised (OCI-R) Score(Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months)
- Changes in Hamilton Anxiety Scale Score(Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months)
- Changes in Hamilton Depression Scale-17 Score(Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months)
- Magnetic resonance imaging (MRI) images(Baseline (preoperative))
- Change in impulsivity and compulsivity(Baseline (preoperative),6 months or 12 months)
- Change in Young Manic Rating Scale(YMRS)(Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months)
- Changes in WHOQOL-BREF score(Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months)
- Changes in PSS-10 score(Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months)
- Change in Sheehan Disability Scale(Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months)
- Changes in SF-36 score(Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months)
- Changes in Q-LES-Q-SF score(Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months)
- Changes in PANAS score(Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months)
研究者
Bomin Sun
Director of Functional Neurosurgery Department
Ruijin Hospital
研究点 (1)
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