taVNS Therapy for Social Anxiety Disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, sham-controlled pilot study evaluating transcutaneous auricular vagus nerve stimulation (taVNS) for social anxiety disorder. Participants receive either active taVNS or sham stimulation using identical devices, with stimulation intensity tailored to tolerance (up to 5 mA) or a sham 0.1 mA. The trial aims to assess preliminary efficacy on social anxiety symptoms and to monitor safety and treatment adherence. Outcomes will inform future larger trials in this area.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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.

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. 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.

Where it's running

• The Second Affiliated Hospital Zhejiang University School of Medicine
  Hangzhou, Zhejiang, China Recruiting
• The Second Affiliated Hospital Zhejiang University School of Medicine
  Hangzhou, Zhejiang, China Not yet recruiting

Study contacts

• Principal investigator: Han Xu — The Second Affiliated Hospital Zhejiang University of medicine
• Study coordinator: Bin Gao
• Email: zjugaobin@163.com
• Phone: +8618768188021

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.