NCT07369908

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2025

Completed
10 days until next milestone

Study Start

First participant enrolled

October 9, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 27, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2026

Completed
Last Updated

January 27, 2026

Status Verified

September 1, 2025

Enrollment Period

5 months

First QC Date

September 29, 2025

Last Update Submit

January 18, 2026

Conditions

Keywords

taVNSanxietyemotional regulationhigh-trait anxiety

Outcome Measures

Primary Outcomes (3)

  • Brain activity patterns in response to negative pictures during emotional regulation

    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.

    60 minutes

  • Resting-state functional conetivity changes

    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.

    15 minutes

  • Behavioral indices in the task

    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)

    60 minutes

Secondary Outcomes (3)

  • 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).

Study Arms (4)

Experiment and high trait anxiety group

EXPERIMENTAL

male and female subjects with high trait anxiety and experimental treatment

Device: taVNS on tragus of subjects with high trait anxiety

Sham control and high trait anxiety group

SHAM COMPARATOR

male and female subjects with high trait anxiety and sham treatment

Device: taVNS on earlobe of subjects with high trait anxiety

Experiment and no high trait anxiety group

EXPERIMENTAL

male and female subjects with no high trait anxiety and experimental treatment

Device: taVNS on tragus of subjects with no high trait anxiety

Sham control and no high trait anxiety group

SHAM COMPARATOR

male and female subjects with no high trait anxiety and sham treatment

Device: taVNS on earlobe of subjects with no high trait anxiety

Interventions

15 minutes taVNS on tragus

Experiment and high trait anxiety group

15 minutes taVNS on earlobe

Sham control and high trait anxiety group

15 minutes taVNS on tragus

Experiment and no high trait anxiety group

15 minutes taVNS on earlobe

Sham control and no high trait anxiety group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Electronic Science and Technology of China (UESTC)

Chengdu, Sichuan, 611731, China

RECRUITING

MeSH Terms

Conditions

Anxiety DisordersEmotional Regulation

Condition Hierarchy (Ancestors)

Mental DisordersSelf-ControlSocial BehaviorBehavior

Study Officials

  • Shuxia Yao, Dr

    University of Electronic Science and Technology of China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Keith M Kendrick, Dr

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 29, 2025

First Posted

January 27, 2026

Study Start

October 9, 2025

Primary Completion

March 16, 2026

Study Completion

April 16, 2026

Last Updated

January 27, 2026

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations