Transcutaneous Vagus Nerve Stimulation for Generalized Anxiety Disorder

NCT06134323 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2023-12-20

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Xijing Hospital

    lead OTHER

Principal Investigators

  • Yihuan Yihuan · The First Affiliated Hospital of the Air Force Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-05
Primary Completion
2025-08-30
Completion
2025-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06134323 on ClinicalTrials.gov