Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)Therapy for Social Anxiety Disorder
Recruiting · NCT07772401 · Interventional (participants receive a specific treatment) · Lead sponsor: Second Affiliated Hospital, Zhejiang University, School of Medicine
View the official record on ClinicalTrials.gov →Interventions studied
sham-taVNStaVNS
What this trial is about
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?
Who can take part
Age range
18 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 Impression-Severity (CGI-S) score of ≥4.
- Age between 18 and 70 years. Voluntary provision of written informed consent. If on psychotropic medications, maintenance of a stable dose for at least six weeks prior to enrollment.
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 substance 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 is running
2 locations listed.
- The Second Affiliated Hospital Zhejiang University School of Medicine - Hangzhou, Zhejiang, China
- The Second Affiliated Hospital Zhejiang University School of Medicine - Hangzhou, Zhejiang, China