Brain Electrophysiological Study(EEG/ERP) on Opiate Addicts Treating by Bilateral NAc/ALIC Deep Brain Stimulation
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
- Event related potentials(ERPs)
研究概览
简要总结
Drug addiction is compulsive and spontaneous drug-taking behavior which is characterized by non-medical usage, long and repeated exposure to addictive drugs and gradually increasing drug-taking dosage and frequency,and become a main threat against human being's public health, economic development and social safety.
详细描述
Effective treatments for severe drug addiction are limited. China centers employing compulsory detoxification, reported a 3 year abstinence rate of only 15%. For the methadone maintenance therapy, relapse often occurs promptly after cessation of methadone. A Malaysian reports about taking naltrexone or buprenorphine treating,showed average relapsed time of 2 or 3 months,respectively.
Assessment for psychological craving degree of addiction patients is also a difficult thing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (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
- 是
入选标准
- •Age between 18 and 65 years of age, male or female；
- •Opiate addictive over 3 years；
- •Physical detoxification completed（keep abstinent for at least 7 days，acute abstinent syndrome disappeared，morphine urinalysis and naloxone test showed negative)；
- •No obvious neuropsychiatry and personality disorders；
- •No severe infectious disease；
- •Good compliance and be able to complete follow up；
- •General health is good，no severe liver、kidney、heart and lung disease；
- •Informed consent issued
排除标准
- •Severe cognitive disorders（MMSE scale: illiteracy≤17，primary school≤20，secondary school or above≤24）,bad compliance because of dementia,unable to issue the informed content；
- •History of severe neuropsychiatric disease；
- •severe liver、kidney、heart and lung disease, severe hypertension and severe orthostatic hypotension；
- •Malignant tumor；History of brain trauma；Pregnant female；
- •Patients are taking part in other clinical trials in recent 3 months；
- •Being deem as unfit for the trials by researcher.
研究组 & 干预措施
Non operation
Recording the event related potential of drug addicts when they receive the stimulus of Emotional pictures stimulation system.
干预措施: Emotional pictures stimulation system (Device)
Deep brain stimulation
Recording the event related potential after the deep brain stimulation operation.Recording the local field potential of drug addiction people when we conduct a test of adjacent contact stimulation in the deep brain stimulation operation. Recording the waveform of bilateral NAc/ALIC after puting the microelectrodes into bilateral nucleus accumbens and anterior limb of the internal capsule
干预措施: Emotional pictures stimulation system (Device)
Deep brain stimulation
Recording the event related potential after the deep brain stimulation operation.Recording the local field potential of drug addiction people when we conduct a test of adjacent contact stimulation in the deep brain stimulation operation. Recording the waveform of bilateral NAc/ALIC after puting the microelectrodes into bilateral nucleus accumbens and anterior limb of the internal capsule
干预措施: Deep brain stimulation (Procedure)
Deep brain stimulation
Recording the event related potential after the deep brain stimulation operation.Recording the local field potential of drug addiction people when we conduct a test of adjacent contact stimulation in the deep brain stimulation operation. Recording the waveform of bilateral NAc/ALIC after puting the microelectrodes into bilateral nucleus accumbens and anterior limb of the internal capsule
干预措施: adjacent contact stimulation (Procedure)
Deep brain stimulation
Recording the event related potential after the deep brain stimulation operation.Recording the local field potential of drug addiction people when we conduct a test of adjacent contact stimulation in the deep brain stimulation operation. Recording the waveform of bilateral NAc/ALIC after puting the microelectrodes into bilateral nucleus accumbens and anterior limb of the internal capsule
干预措施: microelectrode (Procedure)
Standard Control
Recording the event related potential of normal people when they receive the stimulus of emotional pictures stimulation system.
干预措施: Emotional pictures stimulation system (Device)
结局指标
主要结局
Event related potentials(ERPs)
时间窗: Day 3
Event related potentials include late positive potential（LPP),P300,mismatch negativity(MMN) and N400.Recording the event related potential when people receive the stimulus of emotional pictures stimulation system.
次要结局
- Self-Rating Depression Scale(SDS)(day 3)
- participants' craving for opioid drugs (VAS)(day 3)
- Yale-Brown Obsessive Compulsive Scale(Y-BOCS)(day 3)
- The Eysenck Personality Questionnaire(EPQ)(day 3)
- The Wechsler Memory Scale(WMS)(day 3)
- local field potential(LFP)(in surgery,3 days after surgery)
- the 13-item obsessive compulsive drug use scale(OCDUS)(day 3)
- Opiate Addiction Severity Inventory(OASI)(day 3)
- The Symptom Checklist-90(SCL-90)(day 3)
研究者
Guodong Gao
Neurosurgery Department
Tang-Du Hospital