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Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)Therapy for Social Anxiety Disorder
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)Therapy for Social Anxiety Disorder
RecruitingNA
Sponsor: Second Affiliated Hospital, Zhejiang University, School of Medicine
Conditions: Social Anxiety Disorder, Social Fear
Interventions: taVNS, sham-taVNS
Countries: China
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?
Eligibility overview
Sex: ALL
Age: 18 Years to 70 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility criteria
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.
Locations (2)
- Hangzhou, Zhejiang, China
- Hangzhou, Zhejiang, China