NCT06134323

Transcutaneous Vagus Nerve Stimulation for Generalized Anxiety Disorder

Efficacy and Mechanism of Transcutaneous Vagus Nerve Stimulation in the Treatment of Generalized Anxiety Disorder

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, parallel-controlled study of patients with generalized anxiety disorder, who will be randomly assigned to either drug-combined transcutaneous vagus nerve stimulation (tVNS) group or drug-combined sham-stimulation group for a period of 4 weeks of treatment.Scale assessments will be performed at baseline, week 1, week 2, week 3, and week 4 of treatment, and brain function monitoring as well as laboratory tests will be performed at baseline and at the end of treatment, respectively.The aim of this study is to investigate the efficacy of medication combined with tVNS and the possible mechanisms of tVNS in the treatment of anxiety.

Conditions

• Generalized Anxiety Disorder

Interventions

Type	Name	Description
DEVICE	medication-combined transcutaneous vagus nerve stimulation	Two electrodes will be applied 2 cm below the left carotid sinus for active stimulation
DEVICE	medication-combined sham stimulation	Two electrodes will be applied 2 cm below the left carotid sinus for sham stimulation

Timeline

• Start date: 2023-12-05
• Primary completion: 2025-08-30
• Completion: 2025-09-30
• First posted: 2023-11-18
• Last updated: 2023-12-20

Locations

2 sites across 1 country: China