Deep Brain Stimulation of Nucleus Accumbens for Methamphetamine Addiction
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- change in 10-point visual analog scale of carving
研究概览
简要总结
The main objective of this study is to assess the efficacy of bilateral deep brain stimulation (DBS) of the Nucleus Accumbens(NAc) as a novel treatment in severe methamphetamine addiction. Our hypothesis is that bilateral DBS of the NAc will significantly reduce the craving for methamphetamine.
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
- •DSM-IV-TR diagnosis of Drug addiction disorder;
- •Age 18-65 years old;
- •Proficiency in Mandarin language;
- •Failure to detox more than three times;
- •Capacity to provide informed consent (understanding of the study purpose and methods);
排除标准
- •Multidrug abuse and formation of addiction;
- •Serious and unstable organic diseases (e.g. unstable coronal heart disease);
- •Any history of seizure disorder or hemorrhagic stroke;
- •Past stereotactic neurosurgical intervention;
- •Neurological disease (Abnormal PET-CT, MRI, EEG)
- •Contraindications of MRI-examination, e.g. implanted cardiac pacemaker/ heart defibrillator;
- •Contraindications of stereotactic intervention, e.g. increased bleeding disposition, cerebrovascular diseases (e.g. arteriovenous malfunction, aneurysms, systemic vascular diseases);
- •HIV positive;
- •Pregnancy and/or lactation;
研究组 & 干预措施
Bilateral surgical implantation of DBS system to NAc
干预措施: Bilateral surgical implantation of DBS system to NAc (Procedure)
结局指标
主要结局
change in 10-point visual analog scale of carving
时间窗: Baseline (preoperative),3 months,6 months, 12 months
The score of scale is from 0 to 10. 0 represents no carving for drug, 10 means the greatest degree of carving for drug.
change in Obsessive Compulsive Drug Use Scale
时间窗: Baseline (preoperative),3 months,6 months, 12 months
次要结局
- Change in the Hamilton Anxiety Scale(Baseline（preoperative）,3 months, 6 months, 12months)
- Change in the Hamilton Depression Scale(Baseline（preoperative）,3 months, 6 months, 12 months)
- Change in the Quality of Life Assessment (SF-36)(Baseline（preoperative）,3 months, 6 months, 12 months)
- Chang in Pittsburgh Sleep Quality Index(Baseline（preoperative）,3 months,6 months, 12 months)
- Neuropsychological measures(Scores of cognitive battery)(Baseline（preoperative）,6 months,12 months)
- Side Effect(Baseline（preoperative）,3 months, 6 months, 12months)
- Change in World Health Organization Quality of Life-BREF(WHO-BREF)(Baseline（preoperative）,3 months,6 months, 12 months)
- Change in Fagerstrom Test of Nicotine Dependence(FTND)(Baseline（preoperative）,3 months,6 months, 12 months)
研究者
Bomin Sun
Director of the Department of Functional Neurosurgery
Ruijin Hospital