NCT02440152Unknown2 期
The Effectiveness of Deep Brain Stimulation for Opioid Relapse Prevention
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Weekly urine tests
研究概览
简要总结
The nucleus accumbens (NAcc) has a significant role in the process of opiate addiction and the initiation of relapse after detoxification. There is evidence that deep brain stimulation (DBS) of the NAcc exerts a positive effect on individuals with severe heroin addiction via inhibitory action .
The investigators hypothesise that bilateral stimulation of the NAcc will significantly reduce withdrawal symptoms and thus enable the patients to substantially decrease their Levomethadone usage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Proficiency in Mandarin language
- •Long lasting heroin addiction (determined by diagnostic-criteria in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition)
- •Duration longer than 6 months
- •A lack of response to long-term treatment
- •Capacity to provide informed consent (understanding of the study purpose and methods)
- •Substitution methadone treatment at a constant dose within three months prior to inclusion.
排除标准
- •Clinical relevant psychiatric comorbidity (schizophrenic psychoses, bipolar affective diseases with psychotic symptoms)(MINI 6.0)
- •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)
- •Serious and unstable organic diseases (e.g. unstable coronal heart disease)
- •HIV positive
- •Pregnancy and/or lactation
结局指标
主要结局
Weekly urine tests
时间窗: Baseline (preoperative), 3 months, 6 months, 9 months, 12 months, 18 months, 24 months
次要结局
- Change in Hamilton Depression Scale-17(Baseline (preoperative), 3 months, 6 months, 9 months, 12 months, 18 months, 24 months)
- Change in 10-point visual analog scale (VAS) craving score for opioid drugs(Baseline (preoperative), 3 months, 6 months, 9 months, 12 months, 18 months, 24 months)
- Change in SF-36 assessment(Baseline (preoperative), 6 months, 12 month, 24 month)
- Change in Hamilton Anxiety Scale(Baseline (preoperative), 3 months, 6 months, 9 months, 12 months, 18 months, 24 months)
- Neuropsychological measures（Scores of Iowa gambling task and Model task）(Baseline (preoperative), Intraoperative,6 months,12month,24month)
研究者
Bomin Sun
Department of Functional Neurosurgery
Ruijin Hospital
研究点 (2)
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