Neural Alteration Response to Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Depressed Patients

Not Applicable

• Conditions: Depression
• Interventions: Device: Transcutaneous electrical vagus nerve stimulation; Device: Sham vagus nerve stimulation

• Registration Number: NCT03592446
• Lead Sponsor: Xidian University

Brief Summary

Electrical vagus nerve stimulation (VNS) was approved by FDA for treatment of chronic recurrent depression in 2005. Recently, non-invasive, transcutaneous auricular vagus nerve stimulation （taVNS） has already been used for depression treatment. However, the neural mechanism remains unclear, and the relationship between stimulation parameters and neural response were also unknown. The present study aims to investigate the specific brain activation in depression patients after taVNS，compared with healthy controls.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-06
• Study First Submitted: 2018-06-26
• Study First Submitted QC: 2018-07-09
• Last Update Submitted: 2018-07-09
• Study First Posted: 2018-07-19
• Last Update Posted: 2018-07-19
• Study Start: 2018-09-01
• Primary Completion: 2020-07-30
• Study Completion: 2020-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Meets ICD-10 diagnosis standard;
• without taking anti-depressive medication or other psychiatric medications 2 weeks before the experiment;
• Patient has exhibited symptoms for at least 2 months, but no longer than 2 years.

Exclusion Criteria

• With current addiction to drugs;
• With other severe organic diseases, such as severe heart disease, kidney failure etc;
• disagree with the consent form.
• Cannot receive MRI scan.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active-raVNS	Transcutaneous electrical vagus nerve stimulation	Transcutaneous electrical vagus nerve stimulation at ear.
Sham-raVNS	Sham vagus nerve stimulation	Sham vagus nerve stimulation at ear.

Primary Outcome Measures

Name	Time	Method
actual neural activation in brain	2 hours	By using fMRI technology, the BOLD signal of brain is analyzed.

Secondary Outcome Measures

Name	Time	Method
Heart rate variability	2 hours	Frequency domain methods is used to analyze the bands of frequency and then count the number of NN intervals that match each band. The bands are typically high frequency (HF) from 0.15 to 0.4 Hz, low frequency (LF) from 0.04 to 0.15 Hz, and the very low frequency (VLF) from 0.0033 to 0.04 Hz.