Transcutaneous Vagus Nerve Stimulation for Generalized Anxiety Disorder
NCT06134323 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82
Last updated 2023-12-20
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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