Efficacy and Mechanism of Transcutaneous Vagus Nerve Stimulation in the Treatment of Generalized Anxiety Disorder
medication-combined transcutaneous vagus nerve stimulation
+ medication-combined sham stimulation
Generalized Anxiety Disorder
+ Anxiety Disorders
+ Mental Disorders
Treatment Study
Summary
Study start date: December 5, 2023
Actual date on which the first participant was enrolled.The study is designed to explore how effective a treatment combining medication and a technique called transcutaneous vagus nerve stimulation (tVNS) is for people with generalized anxiety disorder. This disorder causes excessive and uncontrollable worry about various aspects of life. The research aims to see not only if this combination helps reduce anxiety symptoms but also to understand how tVNS works in this context. By better understanding these mechanisms, the study hopes to improve treatment options for those struggling with anxiety, offering them more effective ways to manage their condition. Participants in the study are randomly divided into two groups. One group receives the actual tVNS treatment along with their medication, while the other group receives a sham or fake version of the stimulation, also with medication. This approach helps researchers determine the true effectiveness of the real treatment compared to a placebo effect. Over a period of four weeks, participants undergo assessments to measure changes in their anxiety symptoms. Brain function and other laboratory tests are conducted before starting the treatment and after completing it, providing insights into the biological impact of the treatment. The process is carefully monitored to ensure safety and accuracy.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.82 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
The First Affiliated Hospital of Air Force Military Medical University
Xi'an, ChinaOpen The First Affiliated Hospital of Air Force Military Medical University in Google MapsXi'an No.3 Hospital
Xi'an, China