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临床试验/NCT06279273
NCT06279273Unknown不适用

The Dynamic Network Mechanism for the Risky Decision-making Deficits Among Methamphetamine Dependence Individuals and Its Trans-cranial Current Stimulation

Shanghai Mental Health Center1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
cue-induced craving

研究概览

简要总结

The risky decision-making deficits is the core feature of the methamphetamine (MA) dependence. Our previous research found that MA dependents have network abnormalities such as decision-making and rewarding. The feedback-related negativity amplitude in the prefrontal central area of MA users becomes smaller and blunted after a loss. Moreover, the neural modulation over the prefrontal cortex showed potent to decrease the craving, and the functional connectivity between frontal cortex and subparietal lobules increases. It suggests that there is a correlation between the decision-making network and the reward network of MA addicts, but there is no real-time observation of the dynamic changes of these brain network activities, so it is difficult to correct the interaction mechanism.

In order to clarify the dynamic brain network mechanism of the risky decision-making deficits among MA dependents, firstly, based on magneto-encephalography source information reconstruction methods, firstly, based on magneto-encephalography source information reconstruction methods, the investigators will observe the sequence and interaction among decision-making network, rewarding network, and emotion network. Besides, the investigators clarify that the trans-cranial current stimulation over prefrontal cortex could improve the speed and intensity of the key network interactions among MA dependents, which could improve risky decision-making and craving. The successful implementation of the study is expected to provide important clues for elucidating the pathological mechanism of risky decision-making deficits in MA dependents and providing a theoretical basis for the treatment of addiction.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Clinical diagnosis of severe MA defined in the Diagnostic and Statistical Manual of Mental Disorders-Fifth edition (DSM-5); Normal hearing and vision, or within normal range after correction;

排除标准

  • •Clinical diagnosis of substance use disorder other than an MA or nicotine use disorder defined in the Diagnostic and Statistical Manual of Mental Disorders-Fifth edition (DSM-5) in the past 5 years; Suffering from diseases that affect cognitive function (such as cerebrovascular diseases) ; Schizophrenia, bipolar disorder, depression or other Axis I disorder of DSM-V criteria; any contraindication for fMRI scanning.

研究组 & 干预措施

real tDCS

Active Comparator

干预措施: Transcranial direct current stimulation (Device)

sham tDCS

Sham Comparator

干预措施: Transcranial direct current stimulation (Device)

结局指标

主要结局

cue-induced craving

时间窗: Two weeks,Four weeks

Craving was assessed by visual analog scales (VAS), with 0 mm being "no craving"and 100 mm representing "most craving ever experienced for methamphetamine ".

Frontal lobe activation level

时间窗: Two weeks

Balloon Analogue Risk Task during fMRI scanning (Philips Ingenia 3.0T MRI).

次要结局

  • Cognitive function(Two weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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