Transcranial Ultrasound Stimulation as a Neuromodulation Therapy for Craving and Relapse Behaviors in Alcohol Use Disorder.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- The change of drinking symptom
研究概览
简要总结
This study aims to evaluate the efficacy of transcranial ultrasound stimulation in reducing cravings and preventing relapse in individuals with alcohol use disorders. Utilizing a double-blind design, participants will be randomly assigned to receive either active accelerated transcranial ultrasound stimulation or a sham treatment.
详细描述
As a major global public health issue, the core therapeutic goal of alcohol use disorder (AUD) is to reduce alcohol craving and prevent relapse. In recent years, transcranial ultrasound stimulation (TUS) has emerged as a reliable non-invasive neuromodulation technique. Studies have shown that abnormalities in neural activity and structure in the ventromedial prefrontal cortex (vmPFC) of AUD are closely associated with alcohol craving and dysregulation of the reward system. However, existing research on non-invasive neuromodulation techniques for AUD has primarily focused on other brain regions, with limited exploration of interventions targeting the vmPFC. This study aims to evaluate the efficacy of a TUS intervention targeting the vmPFC through a randomized controlled trial, assessing its potential to reduce alcohol craving and prevent relapse, thereby providing a theoretical foundation for clinical translation.
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
- Triple (Participant, Care Provider, Investigator)
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
Intervention group
The active group will receive active transcranial ultrasound stimulation.
干预措施: Active TUS-vmPFC (Device)
Control group
The sham group will receive shame transcranial ultrasound stimulation.
干预措施: Shame TUS-vmPFC (Device)
结局指标
主要结局
The change of drinking 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
Drinking symptom will be measured by Obsessive Compulsive Drinking Scale (OCDS), a 14-item scale assessing obsessive and compulsive drinking behaviors. Each item is scored from 0 to 4 points. The total score of OCDS ranged from 0 to 56.
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 was assessed using the Visual Analog Scale (VAS; 0-10 points, higher scores indicating greater craving) during dual-condition olfactory exposure. Participants completed sequential 1.5-minute sniffing trials with alcohol cues and neutral stimuli (water), with the final craving score calculated as the alcohol-induced VAS score minus the neutral-state baseline.
The change of relapse behaviors with alcohol
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 consumption and related behaviors were assessed using the Alcohol Use Disorders Identification Test (AUDIT,10 item). Each item is scored from 0 to 4 points, with higher scores indicating greater alcohol consumption.
次要结局
- The change of sleep(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 depression(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 anxiety(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 self-control(baseline, immediately after the intervention.)