Effect of High-Intensity Transcranial Alternating Current Stimulation on Gambling Disorder: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change of the gambling symptoms
研究概览
简要总结
The investigators assume that High-intensity transcranial Alternating Current Stimulation (HI-tACS) could improve gambling disorder patients' executive-control function by modulating abnormal neural activity, particularly gamma-band oscillations, which are closely associated with executive-control deficits. This study intends to validate the effect of HI-tACS treatment, which has been discovered in the previous pilot study. A three-month follow-up assessment will be conducted to test the changes in executive-control function and its underlying mechanism.
详细描述
Gambling disorder has become a major social and public health problem in China. Executive-control dysfunction is the main symptom of behavioral addictions such as gambling disorder. Previous studies have demonstrated that abnormal neural activity is distributed across multiple brain regions and networks throughout the whole brain. Research has shown that abnormal neural activity, particularly in the gamma band, contributes to executive-control deficits. High-intensity transcranial Alternating Current Stimulation (HI-tACS) has been found to improve executive-control function by modulating this abnormal gamma-band activity. However, this has not yet been verified in gambling disorder patients. The investigators assume that HI-tACS could improve gambling disorder patients' executive-control function by modulating abnormal gamma-band neural activity, which is closely associated with executive-control deficits. This study intends to test the effect of HI-tACS treatment, which was discovered in a previous pilot study. A three-month follow-up assessment will be conducted to examine changes in executive-control function and its underlying 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
- 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
- •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.
研究组 & 干预措施
Sham stimulation
A 40-minute transcranial alternating current stimulus intervention of sham stimulus is conducted twice a day (at least 3 hours apart) for a total of 10 days in the intervention group of gambling disorder.
干预措施: Sham stimulation (Device)
Intervention group for gambling disorder
A 40-minute transcranial alternating current stimulus intervention of real stimulus is conducted twice a day (at least 3 hours apart) for a total of 10 days in the intervention group of gambling disorder.
干预措施: HI-tACS (Device)
结局指标
主要结局
Change of the gambling symptoms
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 severity will be measured by the Pathological Gambling Yale-Brown Obsessive Compulsive Scale (PG-YBOCS). The total score of PG-YBOCS ranges from 0 to 40, in which higher scores indicate more severe pathological gambling symptoms.
次要结局
- Side effect of the modulation(Immediately after the intervention)
- Change of the gambling symptom severity(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)
- Change of anxiety symptoms(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)
- Change of the gambling craving(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)
- Change of the self-control ability(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)
- Change of depressive symptoms(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)
- Change of the sleep quality(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)
- Change of the resting state neural activity.(Baseline, immediately after the intervention.)
- Change of the risky decision-making performance(Baseline, immediately after the intervention.)
- Change of the inhibitory control performance(Baseline, immediately after the intervention.)