The Modulatory Effects of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) on Anxiety Responses and Emotional Regulation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Brain activity patterns in response to negative pictures during emotional regulation
研究概览
简要总结
The main aim of this study is to investigate whether transcutaneous auricular vagus nerve stimulation (taVNS) can reduce anxiety and have an effect on emotional regulations
详细描述
Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive method for modulating vagal nerve function and has shown potential efficacy in alleviating anxiety symptoms and improving emotional regulation. But the neural mechanisms of how taVNS affects anxiety and emotional regulation remain unclear. Therefore, we focus on this question by combining behavioral meausres, skin conductance response, heart rate variability and fMRI in this study. A participant-blinded, sham-controlled, between-subject design is employed in this study. In a randomised order, a total of 140 healthy males and females with or without high trait anxiety are recruited and receive the stimulation of taVNS on their tragus (experimental group) or earlobe (sham control group). After the participants arrive at the laboratory, they first complete a roughly 30-minute personality trait questionnaire and prepare for the experiment. Then, they undergo a 7-minute resting-state fMRI scan, followed by a 15-minute taVNS session. Next, they complete a 7-minute resting-state scan and a 60-minute task-based scan (a modified emotional regulation task). During the entire procedure, saliva samples will be collected three times for subsequent physiological hormone analyses, and participants' skin conductance and electrocardiogram data will also be recorded. During the modified emotional regulation task, subjects are instructed to regulate their emotional responses to negative pictures (high vs. low intensity) using reinterpretation/distance strategies or to only look these pictures. We also record subjects' rating scores on their anxiety levels during these conditions ("reinterpretation" vs. "distance" vs. "look") and successful usage of emotional regulation strategies. Questionnaire scores including State-Trait Anxiety Inventory, Beck Depression Inventory II, Beck Anxiety Inventory, Autism Spectrum Quotient, Toronto Alexithymia Scale, Social Responsiveness Scale, Emotion Regulation Questionnaire, Cognitive Emotion Regulation Questionnaire, Multidimensional Assessment of Interoceptive Awareness, Positive and Negative Affect Schedule will also be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 30 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects without past or current psychiatric or neurological disorders.
排除标准
- •History of head injury.
- •Medical or psychiatric illness.
- •Subjects take a certain drug for a long period of time.
- •Subjects have metal implants in their bodies.
研究组 & 干预措施
Experiment and high trait anxiety group
male and female subjects with high trait anxiety and experimental treatment
干预措施: taVNS on tragus of subjects with high trait anxiety (Device)
Sham control and high trait anxiety group
male and female subjects with high trait anxiety and sham treatment
干预措施: taVNS on earlobe of subjects with high trait anxiety (Device)
Experiment and no high trait anxiety group
male and female subjects with no high trait anxiety and experimental treatment
干预措施: taVNS on tragus of subjects with no high trait anxiety (Device)
Sham control and no high trait anxiety group
male and female subjects with no high trait anxiety and sham treatment
干预措施: taVNS on earlobe of subjects with no high trait anxiety (Device)
结局指标
主要结局
Brain activity patterns in response to negative pictures during emotional regulation
时间窗: 60 minutes
Subjects will receive task-based fMRI scanning (i.e., the modified emotional regulation task) after taVNS and two resting-state fMRI scanning sessions. We will examine these brain response patterns in the modified emotional regulation task via both the conventional univariate analysis and the machine learning-based multivariate pattern analysis.
Resting-state functional conetivity changes
时间窗: 15 minutes
Subjects will receive resting-state fMRI scanning twice before and after taVNS. We will examine resting-state functional conetivity changes induced by taVNS via examining functional conetivity differences between pre- and post-taVNS sessions.
Behavioral indices in the task
时间窗: 60 minutes
Anxiety and success ratings after each regulation trial are recorded in the task. Subjects are instructed to rate their anxiety and success levels using a 9-point Likert scale within 4 seconds (1 = not at all, 9 = very anxious or successful)
次要结局
- Skin conductance responses (SCR) in the emotional regulation task during fMRI scanning(60 minutes)
- HRV in resting-state fMRI and emotional regulation task(75 minutes during scanning)
- Saliva samples analysis(Three time points: pre-taVNS (baseline, 0 minute), immediate post-taVNS (60 minutes post-taVNS), and the end of experiment (70 minutes post-scanning).)
研究者
Shuxia Yao
Associate Professor
University of Electronic Science and Technology of China
