Healthy Male and Female VolunteersNCT07369908
The Effects of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) on Anxiety Responses and Emotional Regulation
A study testing taVNS on tragus of subjects with high trait anxiety, taVNS on earlobe of subjects with high trait anxiety and taVNS on tragus of subjects with no high trait anxiety in people with Healthy Male and Female Volunteers, run by University of Electronic Science and Technology of China at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Male and Female Volunteers
- What is being tested?
- taVNS on tragus of subjects with high trait anxiety, taVNS on earlobe of subjects with high trait anxiety and taVNS on tragus of subjects with no high trait anxiety
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2025to 16 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects without past or current psychiatric or neurological disorders.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
University of Electronic Science and Technology of China (UESTC)
Chengdu, Sichuan, 611731
Keith M Kendrick, Dr, 86-28-61830811, k.kendrick.uestc@gmail.com
About this study
Official title: The Modulatory 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
Read the 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.
- Conditions
- Healthy Male and Female Volunteers
- Being tested
- 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
- Keywords
- taVNS, anxiety, emotional regulation, high-trait anxiety
- Medical subject headings
- Anxiety Disorders, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
taVNS on tragus of subjects with high trait anxietyDevice
15 minutes taVNS on tragus
taVNS on earlobe of subjects with high trait anxietyDevice
15 minutes taVNS on earlobe
taVNS on tragus of subjects with no high trait anxietyDevice
15 minutes taVNS on tragus
taVNS on earlobe of subjects with no high trait anxietyDevice
15 minutes taVNS on earlobe
| Study group | Role | What they receive |
|---|---|---|
| Experiment and high trait anxiety group | Experimental | male and female subjects with high trait anxiety and experimental treatment Receives: 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 Receives: 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 Receives: 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 Receives: Device: taVNS on earlobe of subjects with no high trait anxiety |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
Measured: 60 minutes
Secondary outcomes (3)
Skin conductance responses (SCR) in the emotional regulation task during fMRI scanning
Skin Conductance Response (SCR) data in response to negative pictures while using different regulation strategies are recorded in the emotional regulation task.
Measured: 60 minutes
HRV in resting-state fMRI and emotional regulation task
Heart beat variability (HRV) data are recorded in resting-state fMRI and emotional regulation task.
Measured: 75 minutes during scanning
Saliva samples analysis
Saliva samples will be collected three times for subsequent physiological hormone analysis.
Measured: Three time points: pre-taVNS (baseline, 0 minute), immediate post-taVNS (60 minutes post-taVNS), and the end of experiment (70 minutes post-scanning).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start9 Oct 2025
- Primary completion16 Mar 2026 (estimated)
- Study completion16 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male and Female VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Electronic Science and Technology of China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shuxia Yao, University of Electronic Science and Technology of China
- Investigators
- Shuxia Yao, Dr, Principal investigator, University of Electronic Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07369908
- Sponsor's protocol ID
- UESTC-neuSCAN-97
- Status last verified
- Sep 2025
- First submitted
- 29 Sep 2025
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Modulatory Effects of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) on Anxiety Responses and Emotional Regulation
- ClinicalTrials.gov ID
- NCT07369908
- Acronym / sponsor ID
- UESTC-neuSCAN-97
- Conditions
- Healthy Male and Female Volunteers
- Keywords
- taVNS, anxiety, emotional regulation, high-trait anxiety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University of Electronic Science and Technology of ChinaUniversity, hospital or other
- Study start
- 9 Oct 2025 (actual)
- Primary completion
- 16 Mar 2026 (estimated)
- Study completion
- 16 Apr 2026 (estimated)
- First posted
- 27 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experiment and high trait anxiety group | Experimental | Device: taVNS on tragus of subjects with high trait anxietymale and female subjects with high trait anxiety and experimental treatment |
| Sham control and high trait anxiety group | Sham comparator | Device: taVNS on earlobe of subjects with high trait anxietymale and female subjects with high trait anxiety and sham treatment |
| Experiment and no high trait anxiety group | Experimental | Device: taVNS on tragus of subjects with no high trait anxietymale and female subjects with no high trait anxiety and experimental treatment |
| Sham control and no high trait anxiety group | Sham comparator | Device: taVNS on earlobe of subjects with no high trait anxietymale and female subjects with no high trait anxiety and sham treatment |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy subjects without past or current psychiatric or neurological disorders.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| taVNS on tragus of subjects with high trait anxiety15 minutes taVNS on tragus | Device | Experiment and high trait anxiety group |
| taVNS on earlobe of subjects with high trait anxiety15 minutes taVNS on earlobe | Device | Sham control and high trait anxiety group |
| taVNS on tragus of subjects with no high trait anxiety15 minutes taVNS on tragus | Device | Experiment and no high trait anxiety group |
| taVNS on earlobe of subjects with no high trait anxiety15 minutes taVNS on earlobe | Device | Sham control and no high trait anxiety group |
Primary outcome
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.
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.
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)
3 secondary outcomes
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shuxia Yao, Dr principal investigator
University of Electronic Science and Technology of China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing taVNS on tragus of subjects with high trait anxiety, taVNS on earlobe of subjects with high trait anxiety and taVNS on tragus of subjects with no high trait anxiety in people with Healthy Male and Female Volunteers, run by University of Electronic Science and Technology of China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Keith M Kendrick, Dr (86-28-61830811, k.kendrick.uestc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain activity patterns in response to negative pictures during emotional regulation (time frame: 60 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.