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

NCT07772401 | Recruiting DMC

• 1 other identifier: 2025-0620
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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 events may occur during taVNS treatment, and what is the treatment compliance of the subjects?

Conditions

Social Anxiety Disorder; Social Fear

Keywords

vagus nerve stimulation; social anxiety disorder

Outcome Measures

Primary Outcomes (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%.

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

Secondary Outcomes (10)

• HAMA (Hamilton Anxiety Rating Scale.)

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

• Hamilton Depression Rating Scale (HAMD)

  baseline, week2, week4, week8, week12

• Adherence to the intervention

  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 assessed weekly during the 8-week intervention.

• Social Interaction Anxiety Scale (SIAS)

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

Study Arms (2)

taVNS group

EXPERIMENTAL

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

sham-taVNS group

SHAM COMPARATOR

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

Interventions

taVNS DEVICE

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.

taVNS group

sham-taVNS DEVICE

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.

sham-taVNS group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, Zhejiang University, School of Medicine: lead

Study Sites (2)

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 311500, China

NOT YET RECRUITING

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 311500, China

RECRUITING

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Officials

• Han Xu

  The Second Affiliated Hospital Zhejiang University of medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bin Gao

CONTACT

+8618768188021; zjugaobin@163.com

Bin Gao

CONTACT

18768188021; zjugaobin@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: August 19, 2026
• Study Start: May 5, 2026
• Primary Completion: October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 2, 2026

Record last verified: 2026-04

Locations

CN (2)