Deep Brain Stimulation of the Nucleus Accumbens and the Ventral Anterior Internal Capsule as a Novel Treatment in Severe Alcohol Addiction
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Reduction of Alcohol
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) and the ventral anterior internal capsule (VC) as a novel treatment in severe alcohol addiction. The included patients have been treated so far with drugs that inhibits alcohol, or psychological behavior training.
Our hypothesis is that bilateral NAc-VC DBS will significantly reduce the craving for alcohol and thus enable the patients to decrease their alcohol intake substantially.
详细描述
The nucleus accumbens (NAc) is considered associating with addiction. The ventral anterior internal capsule(VC) is proved a effective target to obsessive compulsive disorder(OCD). Like other addiction behaviors most alcohol addicts contain obsessive compulsive symptom. We explored an operation method, that is, in the Leksell stereotactic positioning system take VC as the point of entry, take NAc as the point of target, then make sure that the distance between entry and target points are included in the four contacts of electrode of DBS. When stimulator is ON the investigators can adjust parameters so that the coverage of electrode contains both Vc and NAc. The investigators suppose that bilateral NAc-VC DBS will significantly reduce the craving for alcohol and thus enable the patients to decrease their alcohol intake substantially.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Long lasting alcohol addiction (fulfilled diagnostic-criteria according to DSM-IV,ICD-10)
- •At least one detoxication-treatment without a long-term period of abstinence has already taken place
- •Long-term inpatient treatment to support abstinence have occurred
- •Free patient's decision / Informed Consent (existing comprehensive ability in meaning, methodology and execution of the study and ability of acceptance)
- •If prior medication, stable dosage of psychopharmacological drugs over the last three months, which shall, after checking be retained during the study
排除标准
- •Hospitalization for psychotic symptoms
- •Clinical relevant psychiatric comorbidity (such as schizophrenic psychoses, bipolar affective diseases, severe personality disorder, and so on. And diagnosed by criteria according to DSM-IV,ICD-10)
- •Contraindications of a MRI-examination, e.g. implanted cardiac pacemaker/ heart defibrillator
- •Current and in the last six months existent paranoid-hallucinated symptomatology
- •Foreign aggressiveness in the last six months
- •Verbal IQ < 85 (evaluated with the Wechsler Adult Intelligence Scale- Chinese Revised (WAIS-CR)
- •Stereotactic respectively neurosurgical intervention in the past
- •Other neurological diseases
- •Contraindications of a stereotactic operation, e.g. increased bleeding-disposition, cerebrovascular diseases (e.g. arteriovenous malfunction, aneurysms, systemic vascular diseases)
- •Serious and instable organic diseases (e.g. instable coronal heart disease)
- •tested positively for HIV
- •pregnancy and/or lactation
结局指标
主要结局
Reduction of Alcohol
时间窗: 7 months
Reduction of the dosage of alcohol(all kinds of liquor were converted into pure alcohol) comparing baseline and the particular ward rounds during and at the end of the crossover-design.
次要结局
- Craving(7 months)
研究者
Guodong Gao
Neurosurgery Department
Tang-Du Hospital