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

Xidian University,China

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.

Study Overview

• Status: Unknown
• Conditions: Depression
• Intervention / Treatment: Device: Transcutaneous electrical vagus nerve stimulation; Device: Sham vagus nerve stimulation

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 66 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active-raVNS; Transcutaneous electrical vagus nerve stimulation at ear.	Device: Transcutaneous electrical vagus nerve stimulation; All subjects receive electrical VNS stimulation at cymba conchae.
Sham Comparator: Sham-raVNS; Sham vagus nerve stimulation at ear.	Device: Sham vagus nerve stimulation; All subjects receive electrical stimulation at earlobe.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
actual neural activation in brain	By using fMRI technology, the BOLD signal of brain is analyzed.	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate variability	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.	2 hours

Collaborators and Investigators

• Sponsor: Xidian University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2018
• Primary Completion (Anticipated): July 30, 2020
• Study Completion (Anticipated): July 30, 2020

Study Registration Dates

• First Submitted: June 26, 2018
• First Submitted That Met QC Criteria: July 9, 2018
• First Posted (Actual): July 19, 2018

Study Record Updates

• Last Update Posted (Actual): July 19, 2018
• Last Update Submitted That Met QC Criteria: July 9, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 81471812

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No