Transcutaneous Vagus Nerve Stimulation for Generalized Anxiety Disorder

Air Force Military Medical University of People's Liberation Army

Status: Enrolling

Conditions: Generalized Anxiety Disorder

Treatments: Device: medication-combined transcutaneous vagus nerve stimulation; Device: medication-combined sham stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06134323

KY20232271-F-1

Details and patient eligibility

About

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.

Enrollment: 82 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Meeting DSM-5 diagnostic criteria for Generalized Anxiety Disorder;
• Having a first episode of Generalized Anxiety Disorder or not having used an anxiolytic, antidepressant, antipsychotic, or anticonvulsant medication in the last 1 month.
• Having a Hamilton Anxiety Scale (HAMA) score of more than 14 and a Hamilton Depression Scale (HAMD-17) score of less than 17.

Exclusion criteria

• Having organic brain lesions (e.g., cerebral hemorrhage, massive cerebral infarction, encephalitis, epilepsy); cardiac QTc interval > 450ms;
• Current or previous diagnosis of other major diseases (e.g., coronary heart disease, pulmonary heart disease, etc.)
• Currently or previously diagnosed with a mental disorder other than anxiety disorder (except for insomnia disorder);
• Those who are participating or have participated in vagus nerve stimulation therapy; those who are participating in transcranial magnetic stimulation or transcranial direct current therapy;
• Pregnant, breastfeeding, or planning to become pregnant during the trial;
• Refusing to sign the informed consent form.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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82 participants in 2 patient groups, including a placebo group

medication-combined transcutaneous vagus nerve stimulation

Experimental group

Description:

Participants will receive anti-anxiety medication and transcutaneous vagus nerve stimulation

Treatment:

Device: medication-combined transcutaneous vagus nerve stimulation

medication-combined sham stimulation group

Placebo Comparator group

Description:

Participants will receive anti-anxiety medication and sham stimulation

Treatment:

Device: medication-combined sham stimulation