Targeting Brain-Heart Coupling to Improve Emotional Inhibitory Control in Alcohol Use Disorder: Mechanistic Insights and Effects of Transcutaneous Auricular Vagus Nerve Stimulation Combined With Mindfulness Training
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Emotional Inhibitory Control Performance in Emotional Go/NoGo Task
研究概览
简要总结
The goal of this clinical trial is to understand whether combining transcutaneous auricular vagus nerve stimulation (taVNS) with mindfulness training can improve emotional inhibitory control in adults with Alcohol Use Disorder (AUD). The study also aims to explore the brain-heart coupling mechanisms underlying these control deficits.
The main questions it aims to answer are:
Do individuals with AUD have abnormal brain-heart coupling associated with impaired emotional inhibitory control? Can taVNS combined with mindfulness training enhance emotional inhibitory control in individuals with AUD compared to sham stimulation? Researchers will compare a group receiving taVNS plus mindfulness training to a group receiving sham stimulation plus mindfulness training to see whether the active intervention improves behavioral performance and brain-heart coupling.
Participants will:
Complete an emotional Go/NoGo task while EEG and ECG data are recorded Receive 10 days of either real or sham taVNS combined with mindfulness training Complete questionnaires and cognitive assessments before and after the intervention
详细描述
This two-part clinical study investigates the mechanisms and intervention effects related to emotional inhibitory control deficits in individuals with Alcohol Use Disorder (AUD), with a specific focus on brain-heart coupling (also referred to as brain-heart interplay, BHI). The study aims to identify the neurophysiological characteristics underlying inhibitory control impairments in AUD and evaluate whether non-invasive vagus nerve stimulation combined with mindfulness training can enhance emotional regulation and cognitive function.
Study 1: Mechanism Exploration Study 1 adopts a case-control observational design. A total of 28 individuals diagnosed with AUD (based on DSM-5 criteria) and 28 age- and education-matched healthy controls are recruited. Participants complete an emotional Go/NoGo task under EEG-ECG hyperscanning. Emotional inhibitory control performance is assessed through behavioral indices (reaction time, error rate) and further analyzed using the Hierarchical Drift Diffusion Model (HDDM) to quantify latent cognitive processing parameters (e.g., drift rate, boundary separation, non-decision time). Brain-heart coupling is evaluated through resting-state EEG-ECG data using multiscale coupling coefficients and maximal information coefficient (MIC) between heart rate variability (HRV) and cortical oscillations (particularly α, β, and θ bands).
Primary outcomes include:
Drift rate and inhibitory control accuracy under emotional interference Degree of BHI (HRV-EEG coupling strength and directionality) The moderating effect of self-reported emotion regulation ability (measured via DERS)
Study 2: Intervention Evaluation
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Meets DSM-5 diagnostic criteria for Alcohol Use Disorder (AUD).
- •Aged 18-55 years.
- •Currently in the post-acute withdrawal phase (≥2 weeks since last alcohol use).
- •No severe psychiatric comorbidities (e.g., schizophrenia, bipolar disorder).
- •No neurological disorders (e.g., epilepsy, traumatic brain injury).
- •Willing to provide informed consent.
排除标准
- •Dependence on other substances (except nicotine).
- •Severe physical illness requiring immediate treatment.
- •Active infectious diseases (e.g., HIV, hepatitis).
- •Inability to complete study procedures (e.g., cognitive impairment).
- •*(For healthy controls in Study 1, inclusion required AUDIT score ≤8, no psychiatric/neurological history, and matched demographics.)*
研究组 & 干预措施
taVNS + Mindfulness Training
Participants in this group will receive 30-minute daily sessions of transcutaneous auricular vagus nerve stimulation (taVNS) combined with standardized mindfulness training for 10 consecutive days. taVNS is delivered using a wearable device targeting the cymba conchae area of the ear. Stimulation parameters include a frequency of 25 Hz and a pulse width of 200 µs. Mindfulness training involves guided audio practice focused on breath awareness and body scanning.
干预措施: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) (Device)
taVNS + Mindfulness Training
Participants in this group will receive 30-minute daily sessions of transcutaneous auricular vagus nerve stimulation (taVNS) combined with standardized mindfulness training for 10 consecutive days. taVNS is delivered using a wearable device targeting the cymba conchae area of the ear. Stimulation parameters include a frequency of 25 Hz and a pulse width of 200 µs. Mindfulness training involves guided audio practice focused on breath awareness and body scanning.
干预措施: Mindfulness Training (Behavioral)
Sham Stimulation + Mindfulness Training
Participants in this group will receive 30-minute daily sessions of sham stimulation (identical device without active current) combined with the same mindfulness training protocol as the experimental group, administered for 10 consecutive days. The sham stimulation mimics the appearance and procedure of active taVNS but delivers no electrical stimulation.
干预措施: Sham Stimulation (Device)
Sham Stimulation + Mindfulness Training
Participants in this group will receive 30-minute daily sessions of sham stimulation (identical device without active current) combined with the same mindfulness training protocol as the experimental group, administered for 10 consecutive days. The sham stimulation mimics the appearance and procedure of active taVNS but delivers no electrical stimulation.
干预措施: Mindfulness Training (Behavioral)
结局指标
主要结局
Emotional Inhibitory Control Performance in Emotional Go/NoGo Task
时间窗: Assessed at baseline (Day 0) and post-intervention (Day 11)
Emotional inhibitory control performance will be assessed based on participants' accuracy in the emotional Go/NoGo task (i.e., proportion of correctly inhibited responses on NoGo trials). The task uses emotionally valenced facial stimuli and requires participants to withhold responses under emotional interference. Accuracy reflects participants' inhibitory control under affective load, which is the primary behavioral index of intervention efficacy.
次要结局
- Drift Rate Estimated by Hierarchical Drift Diffusion Model (HDDM)(Assessed at baseline (Day 0) and post-intervention (Day 11))
- Brain-Heart Coupling Strength (HRV-EEG Coupling)(Assessed at baseline (Day 0) and post-intervention (Day 11))
- Self-Reported Emotion Regulation Ability (DERS Score)(Assessed at baseline (Day 0) and post-intervention (Day 11))
- Alcohol Craving (Visual Analog Scale)(Assessed at Day 0, Day 3, Day 6, Day 11)