An interventional study of taVNS and sham-taVNS in Social Anxiety Disorder and Social Fear, sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. Recruiting at 2 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine · Not applicable, Interventional, and Treatment
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:
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.
367 studies on the registry are indexed under Phobia, Social; 58 are open to participants now.
This study's planned enrollment of 50 is below the median of 76 across 338 interventional studies indexed under Phobia, Social.
Browse Phobia, Social studies →Second Affiliated Hospital, Zhejiang University, School of Medicine is the lead sponsor of 99 studies on the registry; 67 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 2, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Fulfillment of the 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 .
Exclusion Criteria:
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. to auricular vagus nerve stimulation, such as ear infections, inflammation, skin lesions, or 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 . Pregnant or lactating. Other reasons as deemed unsuitable for inclusion by the research team.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Arm 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.
Device: taVNS
Arm 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.
Device: sham-taVNS
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.
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.
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%.
Time frame: Assessments will be conducted at baseline, weeks 2, 4, and 8 of the intervention, and at week 12 during follow-up.
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).
Time frame: Baseline and weeks 2, 4, 8 of intervention, plus 12-week follow-up.
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).
Time frame: baseline, week2, week4, week8, week12
Adherence to the intervention
Intervention completion times or rates will be used for the evaluation.
Time frame: Assessment wii be conducted at baseline, and at weeks 2, 4, and 8 of the intervention.
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.
Time frame: Adherence will be assessed weekly during the 8-week intervention.
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).
Time frame: Baseline and weeks 2, 4, 8 of intervention, plus 12-week follow-up.
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).
Time frame: Baseline and weeks 2, 4, 8 of intervention, plus 12-week follow-up.
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).
Time frame: Baseline and weeks 2, 4, 8 of intervention, plus 12-week follow-up.
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).
Time frame: Baseline and weeks 2, 4, 8 of intervention, plus 12-week follow-up.
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).
Time frame: Baseline and weeks 8 of intervention.
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); ).
Time frame: Baseline and weeks 8 of intervention.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Sep 2025 to primary completion in Aug 2026, 11 months.
Of 142 non-industry interventional studies with no phase under Phobia, Social, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 44. This study's 11 months is below that.
Counting every sponsor, half of 148 studies reached it within 28 months; a quarter within 14 and three quarters within 43.
Start moved once since we started tracking on Sep 25, 2026: May 2026 → Sep 2025, on Oct 19, 2026.
Primary completion moved twice since we started tracking on Sep 25, 2026: Sep 2026 → Aug 2026, last on Oct 19, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Second Affiliated Hospital, Zhejiang University, School of Medicine