High Intensity Alternating Current Stimulation as a Neuromodulation Therapy for Alcohol Use Disorder: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- The change of alcohol craving
研究概览
简要总结
This study aims to explore the efficacy of high intensity transcranial alternating current stimulation on individuals with alcohol use disorders. Utilizing a one-arm pilot study design, participants will undergo transcranial alternating current stimulation.
详细描述
Alcohol use disorder (AUD) is become a major social and public health problem in China. Craving for alcohol and compulsive drinking behavior are the main symptom of AUD. 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 High-Intensity transcranial Alternating Current Stimulation (HI-tACS) could improve executive-control function thus by adjusting the abnormal synchronization. However, it has not been verified among AUD patients. The investigators assume that tACS could improve AUD 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 HI-tACS treatment. Three-month follow-up assessment will be conducted to test the changing of the craving and alcohol use behavior. This study will provide a practical and theoretical basis for developing a novel treatment for AUD.
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
- 否
入选标准
- •Education level of junior high school or above, capable of completing questionnaires and behavioral tests;
- •Aged 18-60 years;
- •Meet DSM-5 diagnostic criteria for Alcohol Use Disorder;
- •No abnormal findings on physical examination;
- •Agree to participate in follow-up assessments;
- •No contraindications for MRI scanning.
排除标准
- •Have impaired intelligence (Intelligence Quotient<70);
- •Prior tDCS or TMS treatment within the past 3 months;
- •Contraindications for TMS therapy (e.g., intracranial metal implants, history of traumatic brain injury, skull defects, cardiac pacemakers, cardiovascular diseases, or epilepsy);
- •Severe somatic diseases or major organ dysfunction;
- •Psychiatric disorders per DSM-5 criteria (e.g., schizophrenia, schizoaffective disorder, intellectual disability, autism spectrum disorder, dementia, memory impairment, or other cognitive disorders).
研究组 & 干预措施
HI-tACS
A 40-minute 15mA transcranial alternating current stimulus intervention with 77.5 Hz of real stimulus is conducted twice a day (at least 3 hours apart) for a total of 10 days in the intervention group of AUD.
干预措施: HI-tACS (Device)
结局指标
主要结局
The change of alcohol 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
Alcohol craving will be measured by the alcohol craving Visual Analog Scale (VAS). The total score of VAS ranged from 0 to 10, in which higher scores mean a higher level of alcohol craving.
The change of drinking 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 drinking will be answered by patients to quantify their gambling behavior.
次要结局
- The change of drinking urge(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)
- The change of abstinence symptom(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 compulsive drinking behavior(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)
- Side effects of the modulation(Immediately 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 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 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 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 the risky decision-making performance(Baseline, two weeks after the intervention.)
- Change of the inhibitory control performance(Baseline, two weeks after the intervention.)
- Change of the resting state neural activity.(Baseline, two weeks after the intervention.)