Accelerated High-Definition Transcranial Alternating Current Stimulation (HD-tACS) for Alcohol Use Disorder: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Change of Craving
研究概览
简要总结
This study aims to systematically explore the effectiveness of accelerated HD-tACS in treating AUD, particularly its efficacy in reducing alcohol craving and preventing relapse in AUD patients.
详细描述
This study conducted a multi-center randomized clinical controlled trial among individuals with alcohol use disorders, aiming to verify the effectiveness of accelerated HD-tACS in targeting the dorsolateral prefrontal cortex for the treatment of AUD. In particular, it aimed to assess the efficacy of accelerated HD-tACS in reducing alcohol craving and reducing relapse. Eligible patients were randomly divided into the accelerated HD-tACS group and the sham stimulation group in a 1:1 ratio. Clinical and electroencephalogram data were collected at baseline and after the intervention. Additionally, a follow-up assessment of alcohol consumption was conducted for all participants after the intervention ended.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range: 18-55 years old, gender not restricted;
- •Meets the DSM-5 diagnostic criteria for alcohol use disorder (moderate to severe);
- •AUDIT score ≥ 16;
- •Baseline score after alcohol cue-induced stimulation is ≥ 3;
- •Completed detoxification treatment before enrollment (moderate to severe), with detoxification duration of ≥ 7 days and ≤ 90 days;
- •Has a primary school education or above, and can understand and complete the research assessment;
- •Voluntarily participated in the study and signed the informed consent form.
排除标准
- •Currently, there are other substance use disorders (except nicotine);
- •Currently, there are schizophrenia, bipolar disorder or other severe psychotic disorders;
- •Has a history of epilepsy or family history of epilepsy;
- •Has a history of brain trauma, brain surgery or intracranial metal implants;
- •Has received electroconvulsive therapy (ECT), transcranial electrical/magnetic/ultrasound stimulation within the past 6 months;
- •Pregnant or lactating women;
- •Other situations that the researchers consider unsuitable for participation in this study.
研究组 & 干预措施
HD-tACS group
Using the transcranial electrical stimulation device, with the ring-shaped focusing technology, the current is locked in the target area through a 4*1 electrode configuration, causing the peak to appear below the central electrode.
干预措施: HD-tACS (Device)
Sham HD-tACS group
Using the transcranial electrical stimulation device, with the ring-shaped focusing technology, the current is locked in the target area through a 4*1 electrode configuration, causing the peak to appear below the central electrode.
干预措施: Sham HD-tACS (Device)
结局指标
主要结局
Change of Craving
时间窗: baseline; The 2nd, 4th, 6th, 8th and 10th days during the intervention period; 4 weeks after treatment; 12 weeks after treatment
Visual Analog Scale, range 0-100 point, the higher the score, the more one wants drugs.
次要结局
- impulsivity(baseline; 1 day after the treatment was completed)
- Negative reinforcement learning task(baseline; 1 day after treatment was completed)
- Changes in Reward Learning(baseline; 1 day after treatment was completed)
- Compulsory drinking(baseline; 1 day after treatment was completed)
- Depressive state(baseline; 1 day after treatment was completed)
- Anxiety state(baseline; 1 day after treatment was completed;)
- Sleeping conditions(baseline; 1 day after the treatment was completed)
- EEG(baseline; 1 day after treatment was completed)
- use of alcohol(4 weeks after treatment; 12 weeks after treatment)