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Social Anxiety DisordertaVNSNCT07772401

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)Therapy for Social Anxiety Disorder

A study testing taVNS in people with Social Anxiety Disorder and Social Fear, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This clinical trial aims to evaluate the efficacy and safety of transcutaneous auricular vagus nerve stimulation (taVNS) in patients with social anxiety disorder (SAD). The study addresses the following key research questions: Does taVNS demonstrate preliminary clinical efficacy in the treatment of SAD? What adverse… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Social Anxiety Disorder, Social Fear
What is being tested?
taVNS
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
2 sitesChina
Study dates
5 Sep 2025to 1 Dec 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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Fulfillment of the DSM-5 diagnostic criteria for Social Anxiety Disorder (SAD). A Liebowitz Social Anxiety Scale (LSAS) score of ≥30 and a Clinical Global Social Phobia Inventory score greater than 30 Age between 18 and 70 years. Voluntary provision of written informed consent.

Who cannot join

  • A lifetime history of bipolar disorder, schizophrenia, or obsessive-compulsive disorder.
  • Any cognitive impairments that could interfere with the study. Significant suicidal ideation or behavior within the past six months. Patients with rapidly deteriorating conditions. Previous taVNS treatment within the past month. Contraindications to auricular vagus nerve stimulation, such as ear infections, inflammation, skin lesions, or hypersensitivity of the ear.
  • Presence of a pacemaker or other implanted medical devices, or severe neurological, renal, cardiovascular, or hepatic diseases.
  • Concurrent engagement in any form of psychotherapy. History of psychotropic medications or alcohol abuse. Inability to comply with psychological assessments. Incapable of providing informed consent. Pregnant or lactating. Other reasons as deemed unsuitable for inclusion by the research team.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

China2 sites, 2 recruiting
  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 311500

    Bin Gao, 18768188021, zjugaobin@163.com

    Not yet recruiting
  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 311500

    Bin Gao Bin Gao, 17799859423, 1096248474@qq.com

    Recruiting

Other trials in China

About this study

Official title: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)for Social Anxiety Disorder: A Randomized Controlled Clinical Trial.

This clinical trial aims to evaluate the efficacy and safety of transcutaneous auricular vagus nerve stimulation (taVNS) in patients with social anxiety disorder (SAD). The study addresses the following key research questions:

  • Does taVNS demonstrate preliminary clinical efficacy in the treatment of SAD?
  • What adverse events may occur during taVNS treatment, and what is the treatment compliance of the subjects?
Read the detailed description

Social Anxiety Disorder (SAD) is a common psychiatric condition characterized by excessive fear of social situations, leading to significant functional impairment and reduced quality of life. Conventional treatments, including pharmacotherapy and cognitive behavioral therapy, have limitations in terms of response rate and adverse effects. Transcutaneous auricular vagus nerve stimulation (taVNS) is a novel, non-invasive neuromodulation approach targeting the auricular branch of the vagus nerve, which has shown potential anxiolytic effects in clinical studies.

This clinical trial is designed to evaluate the efficacy and safety of taVNS in patients with SAD. The trial adopts a randomized, doubled-blind, sham-controlled design. Participants will be allocated to receive either active taVNS or sham stimulation using identical devices. Active taVNS will deliver bilateral electrical stimulation at the concha cymba and concha cavum with a current intensity up to the individual's maximum tolerable level (≤5 mA), whereas sham stimulation will use a weak current intensity of 0.1 mA.

The primary objectives of this pilot study are to determine whether taVNS demonstrates preliminary clinical efficacy in improving social anxiety symptoms and to assess the incidence of adverse events during treatment. The findings will provide critical data to guide future large-scale randomized controlled trials evaluating the therapeutic potential of taVNS in SAD.

Being tested
taVNS, sham-taVNS
Keywords
vagus nerve stimulation, social anxiety disorder
Medical subject headings
Phobia, Social

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • taVNSDevice

    The study will employ the transcutaneous auricular vagus nerve stimulation (taVNS) stimulator for therapeutic intervention. Electrical stimulation was administered at bilateral cymba conchae (kidney auricular point, CO10) and cavum conchae (heart auricular point, CO15). The stimulation parameters were as follows: frequency of 20 Hz, pulse width <1 ms, with current intensity adjusted to the patient's maximum tolerance level while being maintained below 5 mA. The intervention protocol consisted of two 30-minute stimulation sessions per day for 8 consecutive weeks.

  • sham-taVNSDevice

    The study will employ the sham transcutaneous auricular vagus nerve stimulation (sham-taVNS) for this intervention. Electrical stimulation will be administered at bilateral cymba conchae (kidney auricular point, CO10) and cavum conchae (heart auricular point, CO15). The stimulation parameters were as follows: frequency of 20 Hz, pulse width <1 ms, and current intensity of 0.1 mA. The intervention protocol consisted of two 30-minute stimulation sessions per day for 8 consecutive weeks.

Study groups in NCT07772401
Study groupRoleWhat they receive
taVNS groupExperimentalArm Description: Participants in this group will receive transcutaneous auricular vagus nerve stimulation (taVNS) using the TVNS-100 stimulator, with stimulation intensity adjusted to the maximum tolerable level (≤5 mA) for 8 weeks. Assigned Interventions: Device: taVNS The study will employ the taVNS for therapeutic intervention. Electrical stimulation will be administered at bilateral cymba conchae (kidney auricular point, CO10) and cavum conchae (heart auricular point, CO15). The stimulation parameters will be: frequency of 20 Hz, pulse width <1 ms, with current intensity adjusted to the patient's maximum tolerance level while being maintained below 5 mA. The intervention protocol consists of two 30-minute stimulation sessions per day for 8 consecutive weeks.
Receives: Device: taVNS
sham-taVNS groupSham comparatorArm Description: Participants in this group will receive sham stimulation using the same device, delivering a weak current (0.1 mA) intended to mimic taVNS without therapeutic effect, for 8 weeks. Assigned Interventions: Device: sham transcutaneous auricular vagus nerve stimulation (sham-taVNS) The study will employ the sham taVNS for this intervention. Electrical stimulation will be administered at bilateral cymba conchae (kidney auricular point, CO10) and cavum conchae (heart auricular point, CO15). The stimulation parameters will be: frequency of 20 Hz, pulse width <1 ms, and current intensity of 0.1 mA. The intervention protocol consists of two 30-minute stimulation sessions per day for 8 consecutive weeks.
Receives: Device: sham-taVNS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. LSAS (Liebowitz Social Anxiety Scale)

    The outcome measure is the percentage reduction rate of the Liebowitz Social Anxiety Scale (LSAS) total score (unit: %, measurement tool: Liebowitz Social Anxiety Scale, a 24-item self-report questionnaire). The LSAS is a 24-item scale with a minimum total score of 0 and a maximum total score of 144; higher scores indicate more severe social anxiety symptoms (i.e., a worse outcome). The primary outcome was the change in LSAS total score, with core efficacy evaluated based on the difference in total scores between baseline and the 8-week intervention period. The LSAS score reduction rate (%) was calculated as [(Pre-treatment total score - Post-treatment total score) / Pre-treatment total score] × 100%.

    Measured: Assessments will be conducted at baseline, weeks 2, 4, and 8 of the intervention, and at week 12 during follow-up.

Secondary outcomes (10)
  1. HAMA (Hamilton Anxiety Rating Scale.)

    The outcome measure is the total score of the Hamilton Anxiety Rating Scale (HAMA) (measurement tool: Hamilton Anxiety Rating Scale, a 14-item clinician-rated scale; unit: total score). The HAMA is a 14-item scale with a minimum total score of 0 and a maximum total score of 56; higher scores indicate more severe anxiety symptoms (i.e., a worse outcome).

    Measured: Baseline and weeks 2, 4, 8 of intervention, plus 12-week follow-up.

  2. Hamilton Depression Rating Scale (HAMD)

    The outcome measure is the total score of the Hamilton Depression Rating Scale (HAMD) (measurement tool: Hamilton Depression Rating Scale, a 17-item clinician-rated scale; unit: total score). The HAMD is a 17-item scale with a minimum total score of 0 and a maximum total score of 52; higher scores indicate more severe depressive symptoms (i.e., a worse outcome).

    Measured: baseline, week2, week4, week8, week12

  3. Adherence to the intervention

    Intervention completion times or rates will be used for the evaluation.

    Measured: Assessment wii be conducted at baseline, and at weeks 2, 4, and 8 of the intervention.

  4. Rate of adherence to the intervention

    Adherence will be defined as the percentage of prescribed stimulation sessions completed by each participant during the 8-week intervention period. A rate of 100% indicates that all scheduled sessions were completed as instructed.

    Measured: Adherence will be assessed weekly during the 8-week intervention.

  5. Social Interaction Anxiety Scale (SIAS)

    The outcome measure is the total score of the Social Interaction Anxiety Scale (SIAS) (measurement tool: Social Interaction Anxiety Scale, a 20-item self-rated scale; unit: total score). The SIAS is a 20-item scale with a minimum total score of 0 and a maximum total score of 80; higher scores indicate more severe social interaction anxiety symptoms (i.e., a worse outcome).

    Measured: Baseline and weeks 2, 4, 8 of intervention, plus 12-week follow-up.

  6. SAS (Social Adaptation Self-evaluation Scale)

    The outcome measure is the total score of the Social Adaptation Self-evaluation Scale (SAS) (measurement tool: Social Adaptation Self-evaluation Scale, a 21-item self-rated scale; unit: total score). The SAS is a 21-item scale with a minimum total score of 0 and a maximum total score of 63; higher scores indicate poorer social adaptation status (i.e., a worse outcome).

    Measured: Baseline and weeks 2, 4, 8 of intervention, plus 12-week follow-up.

  7. BFNE (Brief Fear of Negative Evaluation Scale)

    The outcome measure is the total score of the Brief Fear of Negative Evaluation Scale (BFNE) (measurement tool: Brief Fear of Negative Evaluation Scale, a 12-item self-rated scale; unit: total score). The BFNE is a 12-item scale with a minimum total score of 12 and a maximum total score of 60; higher scores indicate more severe fear of negative evaluation (i.e., a worse outcome).

    Measured: Baseline and weeks 2, 4, 8 of intervention, plus 12-week follow-up.

  8. Pittsburgh Sleep Quality Index (PSQI)

    The outcome measure is the total score of the Pittsburgh Sleep Quality Index (PSQI) (measurement tool: Pittsburgh Sleep Quality Index, a 19-item self-rated scale; unit: total score). The PSQI is a 19-item scale with a minimum total score of 0 and a maximum total score of 21; higher scores indicate poorer overall sleep quality (i.e., a worse outcome).

    Measured: Baseline and weeks 2, 4, 8 of intervention, plus 12-week follow-up.

  9. HRV (Heart Rate Variability)

    The outcome measure is the heart rate variability (HRV) (measurement tool: standardized electrocardiographic monitoring system; unit: millisecond). HRV reflects the autonomic nervous system regulatory function; lower HRV values indicate poorer cardiac autonomic regulation and higher physiological stress levels (i.e., a worse outcome).

    Measured: Baseline and weeks 8 of intervention.

  10. blood IL-6, IL-10, CRP, cortisol

    The outcome measure is the serum level of Interleukin-6 (IL-6), Interleukin-10 (IL-10), cortisol, C-reactive Protein (CRP)(measurement tool: enzyme-linked immunosorbent assay (ELISA); ).

    Measured: Baseline and weeks 8 of intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2026
  2. Study start5 Sep 2025
  3. Primary completion31 Aug 2026
  4. Study completion1 Dec 2026 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07772401
Sponsor's protocol ID
2025-0620
Acronym
taVNS
Status last verified
Apr 2026
First submitted
22 Jul 2025
Last updated
19 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing taVNS in people with Social Anxiety Disorder and Social Fear, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 2 sites 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 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 Bin Gao (+8618768188021, zjugaobin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

LSAS (Liebowitz Social Anxiety Scale) (time frame: Assessments will be conducted at baseline, weeks 2, 4, and 8 of the intervention, and at week 12 during follow-up.). 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 19 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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