Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07369908

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

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Electronic Science and Technology of China (UESTC)

Chengdu, Sichuan, 611731, China

Location status: Recruiting

Location contact

Keith M Kendrick, Dr

CONTACT

[email protected]

86-28-61830811

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy subjects without past or current psychiatric or neurological disorders.

Exclusion criteria

  • 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.

Treatment and study plan

taVNS on tragus of subjects with high trait anxiety

Device

15 minutes taVNS on tragus

taVNS on earlobe of subjects with high trait anxiety

Device

15 minutes taVNS on earlobe

taVNS on tragus of subjects with no high trait anxiety

Device

15 minutes taVNS on tragus

taVNS on earlobe of subjects with no high trait anxiety

Device

15 minutes taVNS on earlobe

Primary outcomes

  1. Brain activity patterns in response to negative pictures during emotional regulation

    Time frame: 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.

  2. Resting-state functional conetivity changes

    Time frame: 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.

  3. Behavioral indices in the task

    Time frame: 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)

Secondary outcomes

  1. Skin conductance responses (SCR) in the emotional regulation task during fMRI scanning

    Time frame: 60 minutes

    Skin Conductance Response (SCR) data in response to negative pictures while using different regulation strategies are recorded in the emotional regulation task.

  2. HRV in resting-state fMRI and emotional regulation task

    Time frame: 75 minutes during scanning

    Heart beat variability (HRV) data are recorded in resting-state fMRI and emotional regulation task.

  3. Saliva samples analysis

    Time frame: Three time points: pre-taVNS (baseline, 0 minute), immediate post-taVNS (60 minutes post-taVNS), and the end of experiment (70 minutes post-scanning).

    Saliva samples will be collected three times for subsequent physiological hormone analysis.

Study contacts

Contact information is provided by the study sponsor or research team.

Keith M Kendrick, Dr

CONTACT

[email protected]

86-28-61830811

Sponsors and collaborators

Lead sponsor

University of Electronic Science and Technology of China

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 27, 2026
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.