跳至主要内容
临床试验/NCT06195995
NCT06195995招募中不适用

Brain Mechanism and Intervention of Executive-control Dysfunction Among Gambling Disorder

Shanghai Mental Health Center1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年1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
20
试验地点
1
主要终点
The change of gambling craving

研究概览

简要总结

The investigators assume that transcranial Alternating Current Stimulation (tACS) could improve gambling disorder patients' executive-control function by adjusting the synchronization patterns and enhancing the functional connectivity of the prefrontal-ventral striatum pathway. This study intends to test the effect of tACS treatment. Three-month follow-up assessment will be conducted to test the changing of the executive-control function and its mechanism.

详细描述

Gambling disorder is become a major social and public health problem in China. Executive-control dysfunction is the main symptom of behavioral addiction like gambling disorder. 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 cognition, and transcranial Alternating Current Stimulation (tACS) could improve executive-control function by adjusting the abnormal synchronization. However, it has not been verified among gambling disorder patients. The investigators assume that tACS could improve gambling disorder patients' executive-control function by adjusting the synchronization patterns and enhancing the functional connectivity of the prefrontal-ventral striatum pathway. This study intends to test the effect of tACS treatment. Three-month follow-up assessment will be conducted to test the changing of the executive-control function and its mechanism. This study will provide a practical and theoretical basis for developing a novel treatment for gambling disorder.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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 and Statistical Manual of mental disorders,DSM) diagnostic criteria for gambling disorder
  • Have gambled 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 (Intelligence Quotient<70)
  • Abuse or dependence of psychoactive substances (except nicotine) in the last 5 years

结局指标

主要结局

The change of gambling craving

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

Gambling craving will be measured by the gambling craving Visual Analog Scale (VAS). The total score of VAS ranged from 0 to 10, in which higher scores mean a higher level of gambling craving.

The change of gambling symptom

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

Gambling symptom will be measured by the Gambling Symptom Assessment Scale (G-SAS). The total score of G-SAS ranged from 0 to 48, in which higher scores mean a higher level of gambling symptom.

The change of gambling behavior

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

Questions including monetary loss, time, frequency and interval of gambling will be answered by patients to quantify their gambling behavior.

The change of pathological gambling

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

Pathological gambling will be measured by the Yale-Brown Obsessive Compulsive Scale adapted for Pathological Gambling (PG-YBOCS). The total score of PG-YBOCS ranged from 0 to 40, in which higher scores mean a higher level of pathological gambling.

次要结局

  • The change of self-control(baseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months 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

Brain Mechanism and Intervention of... | 临床试验