Generalized Anxiety Disorder
Conditions
Interventions
Active taVNS Group:1.Stimulation Site: Cavum conchae and triangular fossa of the auricle , the core distribution area of the auricular branch of the vagus nerve (ABVN) .
2.Core Stimulation Parameters:
pulse width 0.2 ms. Stimulation intensity was set to the maximum tingling sensation tolerable by the subject, without sharp pain.
3.Intervention Duration and Frequency: Stimulation was applied alterna
Sham taVNS Group :1.Stimulation Site: Tragus of the auricle, an area without distribution of the auricular branch of the vagus nerve.
2.Stimulation Parameters and Intervention Protocol: The device app
Sponsors
The Fourth People's Hospital of Chengdu
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 65 years, regardless of gender; m 2. Meeting the diagnostic criteria for generalized anxiety disorder as specified in the *Diagnostic and Statistical Manual of Mental Disorders (5th Edition)* (DSM-5); 3. Having a baseline total score of >=14 on the Hamilton Anxiety Rating Scale (HAMA-14), indicating moderate to severe anxiety symptoms; 4. For participants receiving medication: maintaining a stable dosage of anxiolytic/antidepressant medications within 4 weeks prior to enrollment, and committing not to adjust the medication regimen during the study period; 5. For medication-free participants: having not used any anxiolytic, antidepressant, sedative or hypnotic drugs within 4 weeks prior to enrollment; 6. Right-handed, having no contraindications for fNIRS examination, and being able to cooperate in completing cranial fNIRS and HRV examinations; 7. Fully understanding the study procedures, voluntarily signing a written informed consent form, and committing to cooperating in completing the entire follow-up process.
Exclusion criteria
Exclusion criteria: 1. Meeting the diagnostic criteria for other major mental disorders as specified in DSM-5, including schizophrenia spectrum disorders, bipolar disorder, major depressive disorder, obsessive-compulsive disorder, post-traumatic stress disorder, and substance use disorder; 2. Having a clear suicide risk with a score of >=3 on the suicide item of the Montgomery-Åsberg Depression Rating Scale (MADRS); 3. A previous history of vagus nerve stimulation (VNS/taVNS) treatment, or having received other neuromodulation therapies such as rTMS, electroconvulsive therapy, or deep brain stimulation within 3 months prior to enrollment; 4. Severe physical diseases including severe cardiac, hepatic, renal, or pulmonary insufficiency, uncontrolled hypertension/diabetes mellitus, malignant tumors, autoimmune diseases, organic lesions of the central nervous system, and severe infections; 5. Ear diseases such as auricular deformity, external otitis media, otitis media, and damaged skin/rash on the ear that prevents the wearing of stimulation electrodes; 6. Damaged skin, rash, or allergy to electrode patches at the HRV electrode attachment sites; 7. Participation in other clinical trials, or any other conditions judged by the investigator as unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Anxiety Scale-14; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time-domain indices of heart rate variability;Frequency domain indices of heart rate variability;Pittsburgh sleep quality index;Zung self-Rating Anxiety Scale;Zung Self-Rating Depression Scale;Beck Scale for Suicide Ideation;HbO2;Hb; | — |
Countries
China
Contacts
Public ContactYue Yu
The Fourth People's Hospital of Chengdu
Outcome results
None listed