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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
82
Two electrodes will be applied 2 cm below the left carotid sinus for active stimulation
Two electrodes will be applied 2 cm below the left carotid sinus for sham stimulation
The First Affiliated Hospital of Air Force Military Medical University
Xi'an, Shaanxi, China
RECRUITINGXi'an No.3 Hospital
Xi'an, Shaanxi, China
RECRUITINGChanges in the Hamilton Anxiety Scale at Baseline and Week 2 of Treatment
The Hamilton Anxiety Scale is a physician evaluation scale commonly used in clinical practice to assess the level of anxiety in patients. Changes in its scores accurately reflect changes in anxiety symptoms. In this study, changes in scores at baseline and the second week of treatment will be used as the primary outcome measure.
Time frame: Baseline and Week 2 of the treatment
Changes in the Hamilton Anxiety Scale at Baseline and Week 4 of Treatment
The Hamilton Anxiety Scale is a physician evaluation scale commonly used in clinical practice to assess the level of anxiety in patients. Changes in its scores accurately reflect changes in anxiety symptoms.Higher scores mean that the patient's anxiety is more severe.
Time frame: Baseline and Week 4 of the treatment
Changes in the Hamilton Depression Scale at Baseline and Week 2 of Treatment
The Hamilton Depression Scale is a physician evaluation scale commonly used in clinical practice to assess the level of depression in patients. Changes in its scores accurately reflect changes in depressive symptoms.Higher scores mean that the patient is more severely depressed.
Time frame: Baseline and Week 2 of the treatment
Changes in the Hamilton Depression Scale at Baseline and Week 4 of Treatment
The Hamilton Depression Scale is a physician evaluation scale commonly used in clinical practice to assess the level of depression in patients. Changes in its scores accurately reflect changes in depressive symptoms.Higher scores mean that the patient is more severely depressed.
Time frame: Baseline and Week 4 of the treatment
Changes in the Generalized Anxiety Scale at Baseline and Week 2 of Treatment
The Generalized Anxiety Scale is a self-assessment scale commonly used in clinical practice to evaluate generalized anxiety symptoms. It has only 7 items and is easy to use.Higher scores mean that the patient's anxiety is more severe.
Time frame: Baseline and Week 2 of the treatment
Changes in the Generalized Anxiety Scale at Baseline and Week 4 of Treatment
The Generalized Anxiety Scale is a self-assessment scale commonly used in clinical practice to evaluate generalized anxiety symptoms. It has only 7 items and is easy to use.Higher scores mean that the patient's anxiety is more severe.
Time frame: Baseline and Week 4 of the treatment
Changes in brain function indicators from baseline to end of treatment
Functional near-infrared spectroscopy and event-related potentials will be used in this study to examine brain function in patients.Event-related potential (ERP) is a special brain evoked potential that is generated by intentionally giving a stimulus a special psychological meaning, using multiple or multiple stimuli. Functional near-infrared spectroscopy (fNIRS) can utilize the good scattering of 600-900nm near-infrared light by the main components of blood to obtain changes in oxyhemoglobin and deoxyhemoglobin during brain activity.
Time frame: Baseline and Week 4 of the treatment
Incidence of adverse events in each group
During the study period, any treatment-related adverse events will be recorded and used to evaluate the safety of the intervention.Common side effects include changes in pronunciation, hoarseness, neck pain, cough, vomiting, etc
Time frame: Baseline and Week 4 of the treatment
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