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临床试验/NCT06145698
NCT06145698招募中不适用

The Exploration of Novel Cross-frequency Protocol of Transcranial Alternating Current Stimulation in the Treatment of Methamphetamine Use Disorder: A Randomized Sham-controlled Study

Shanghai Mental Health Center1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2023年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
32
试验地点
1
主要终点
Change of Craving assessed by Visual Analog Scale

研究概览

简要总结

The purpose of this research is to evaluate the efficacy of multiple sessions of theta-gamma cross-frequency transcranial alternating current stimulation in patients with methamphetamine (MA) use disorders.

详细描述

Previous evidence suggests that different aspects of cognitive function are associated with activities of distinct EEG frequency bands. Gamma oscillatory has been found in clinical studies to reflect the processing of rewards in patients with drug dependence, whereas medial prefrontal theta oscillatory characterizes prefrontal response inhibition capacity to downstream reward arousal. Interestingly, impaired response inhibition or impaired evaluation of rewards in patients with drug dependence have been found to correlate with the arousal of psychological craving and the emergence of relapse. Here we aim to find causal evidence supporting these previous correlational findings by applying cross-frequency transcranial alternating current stimulation (tACS) in the specific frequency bands (theta-gamma) previously shown to be addiction-relevant. In a randomized control clinical trial design, we stimulate subjects with either theta-gamma or sham tACS. Electroencephalography will be collected before and after each treatment session. Besides, the scale and behavior task data will also collected before and after the treatment.

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 59 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • In accordance with the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) for methamphetamine (MA) use disorders
  • Normal vision and hearing
  • Dextromanual
  • Use MA not less than 1 year, and the last of MA use no less than 3 months

排除标准

  • Have a disease that affects cognitive function such as a history of head injury, cerebrovascular disease, epilepsy, etc
  • Have cognitive-promoting drugs in the last 6 months
  • Other substance abuse or dependence in recent five years (except nicotine)
  • Meet the DSM-5 criteria for other mental disorders
  • Physical disease

结局指标

主要结局

Change of Craving assessed by Visual Analog Scale

时间窗: baseline,0-2 days after treatment,1 months after treatment, 3 months after treatment

evaluate all participants' craving for for methamphetamine assessed by Visual Analog Scales (VAS). Score of VAS range from 0 to 10, and higher values represent high level of craving.

次要结局

  • Sleep Quality Assessment(baseline,0-2 days after treatment,1 months after treatment, 3 months after treatment)
  • Brain oscillations(baseline,within 30 minutes before and after each session of treatment)
  • Spatial working memory(baseline,0-2 days after treatment, 3 months after treatment)
  • Depression status assessed by Beck Depression Inventory (BDI)(baseline,0-2 days after treatment,1 months after treatment, 3 months after treatment)
  • Anxiety status assessed by Beck Anxiety Inventory (BAI)(baseline,0-2 days after treatment,1 months after treatment, 3 months after treatment)
  • Reward learning(baseline,0-2 days after treatment, 3 months after treatment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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