跳至主要内容
临床试验/NCT05312359
NCT05312359尚未招募不适用

Brain Mechanism and Intervention of Executive-control Dysfunction Caused by Impaired Prefrontal-ventral Striatum Synchronization Among Substance Dependents

Shanghai Mental Health Center1 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
210
试验地点
1
主要终点
The change of theta(θ) phase synchronicity

研究概览

简要总结

The investigators assume that tACS could improve amphetamine and alcohol dependent patients' executive-control function by adjusting the synchronization patterns and enhancing the functional connectivity of the prefrontal-ventral striatum pathway. A random controlled trial will be used to test the effect of θ-tACS treatment. Three months follow-up assessment will be conducted to test the changing of executive-control function and its mechanism.

详细描述

Substance abuse has become a major social and public health problem in China, especially for amphetamine abuse and alcohol abuse. Executive-control dysfunction is the main symptom for substance dependents. Previous studies have demonstrated the relationship between cognitive dysfunction and prefrontal-ventral striatum pathway. Studies have shown that abnormal phase synchronization and phase-amplitude coupling (PAC) induced the impairment of cognitive, and tACS could improve executive-control function by adjusting the abnormal synchronization. But it has not been verified among MA or alcohol patients. The investigators assume that tACS could improve MA and alcohol dependent patients' executive-control function by adjusting the synchronization patterns and enhancing the functional connectivity of the prefrontal-ventral striatum pathway. A random controlled trial will be used to test the effect of θ-tACS treatment. Three months follow-up assessment will be conducted to test the changing of executive-control function and its mechanism. This study will provide a practical and theoretical basis for developing a novel treatment for substance dependents.

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
Double (Participant, 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

入选标准

  • Aged 18-60, male or female, with 9 or more years of education, and able to complete questionnaire evaluation and behavioral tests
  • Meet DSM-5 diagnostic criteria for amphetamine-type substance addiction or alcohol addiction
  • Have used amphetamine or alcohol for at least one year (at least once a week)
  • Normal vision and hearing, or within the normal range after correction
  • Agree to cooperate in the follow-up evaluation
  • No metal implantation in the head, no history of nerve problems or head injury, and no skin sensitivity

排除标准

  • Have severe cognitive impairment, such as a history of head trauma, cerebrovascular disease, epilepsy, etc.
  • Have used drugs promoting cognitive function in the last 6 months
  • Have impaired intelligence (IQ<70)
  • Abuse or dependence of other psychoactive substances (except nicotine) in the last 5 years

结局指标

主要结局

The change of theta(θ) phase synchronicity

时间窗: baseline, immediately after the intervention, one month after the intervention, three months after the intervention

The change of θ phase synchronicity in the prefrontal - ventral striatum pathway in amphetamine addicts and alcohol addicts will be measured by EEG.

The change of theta-gamma phase amplitude coupling(θ-γ PAC)

时间窗: baseline, immediately after the intervention, one month after the intervention, three months after the intervention

The change of θ-γ PAC in the prefrontal - ventral striatum pathway in amphetamine addicts and alcohol addicts will be measured by EEG.

The change of inhibitory control ability

时间窗: baseline, immediately after the intervention, one month after the intervention, three months after the intervention

The change of inhibitory control ability will be reflected by participants' performance in the Go/No Go task.

次要结局

  • The change of working memory(baseline, immediately after the intervention, one month after the intervention, three months after the intervention)
  • DA metabolic rate(baseline)
  • The change of decision-making ability(baseline, immediately after the intervention, one month after the intervention, three months after the intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验