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Recruiting NCT07369908

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

No phase Interventional Healthy Male and Female Volunteers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: taVNS on tragus of subjects with high trait anxiety, taVNS on earlobe of subjects with high trait anxiety, taVNS on tragus of subjects with no high trait anxiety, taVNS on earlobe of subjects with no high trait anxiety.
Who it may be relevant to
Registry conditions: Healthy Male and Female Volunteers. Basic parameters: 18 years — 30 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Detailed description

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.

Interventions

  • Device taVNS on tragus of subjects with high trait anxiety
    15 minutes taVNS on tragus
  • Device taVNS on earlobe of subjects with high trait anxiety
    15 minutes taVNS on earlobe
  • Device taVNS on tragus of subjects with no high trait anxiety
    15 minutes taVNS on tragus
  • Device taVNS on earlobe of subjects with no high trait anxiety
    15 minutes taVNS on earlobe

Primary outcome measures

  • Brain activity patterns in response to negative pictures during emotional regulation [Time frame: 60 minutes]
  • Resting-state functional conetivity changes [Time frame: 15 minutes]
  • Behavioral indices in the task [Time frame: 60 minutes]
Secondary outcome measures (3)
  • Skin conductance responses (SCR) in the emotional regulation task during fMRI scanning [Time frame: 60 minutes]
  • HRV in resting-state fMRI and emotional regulation task [Time frame: 75 minutes during scanning]
  • 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).]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Basic science

Study locations

China · 1 center
  • University of Electronic Science and Technology of China (UESTC) — Chengdu

Identifiers

NCT: NCT07369908 · UESTC-neuSCAN-97

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗