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

July 9, 2018 updated by: Xidian University

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 2 hours
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
Time Frame: 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.
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xidian University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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