跳至主要内容
临床试验/NCT07369908
NCT07369908招募中不适用

The Modulatory Effects of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) on Anxiety Responses and Emotional Regulation

University of Electronic Science and Technology of China1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2025年10月9日最近更新:
干预措施

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

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

Experimental

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

Sham Comparator

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

Experimental

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

Sham Comparator

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

发起方
University of Electronic Science and Technology of China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Shuxia Yao

Associate Professor

University of Electronic Science and Technology of China

研究点 (1)

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