The Effects of taVNS on Inhibitory Control

December 11, 2023 updated by: Keith Kendrick, University of Electronic Science and Technology of China

Transcutaneous Auricular Vagus Nerve Stimulation Improves Inhibitory Control in Emotional Go-Nogo Task

The main aim of the study is to investigate whether the transcutaneous vagus nerve stimulation(tVNS) improves the ability of inhibitory control in an emotional Go-Nogo task.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A randomized, sham-controlled, between-subject design will be employed in this study. A total of 87 healthy subjects will receive either transcutaneous vagus nerve stimulation via tragus or sham stimulation via the earlobe in the left ear. Brain activity and behavioral data for an emotional Go-Nogo task will be recorded and saliva samples will be collected before, during, and after stimulation.

Some personal traits will be assessed using different kinds of questionnaires, such as the State-Trait Anxiety Inventory (STAI), Beck's Depression Inventory(BDI), Autism Spectrum Quotient (ASQ) et al.

Study Type

Interventional

Enrollment (Actual)

90

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.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 611731
        • University of Electronic Science and Technology of China

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

18 years to 25 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy subjects without past or current psychiatric or neurological disorders

Exclusion Criteria:

  • history of head injury;
  • pregnant, menstruating, taking oral contraceptives;
  • medical or psychiatric illness.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tragus stimulation
Vagus nerve stimulation via tragus
Device: Vagus nerve stimulation via tragus
The device will send stimulus intensity of around 0.5mA via tragus in the left ear (based on participants' subjective report), delivered with a pulse width of 0.5 ms at 25 Hz. Stimulation will be active for 30 seconds, followed by a break of 30 seconds.
Sham Comparator: Sham stimulation
Sham stimulation via earlobe
Device: Sham stimulation via earlobe
The device will send stimulus intensity of around 0.5mA via the earlobe in the left ear (based on participants' subjective reports), delivered with a pulse width of 0.5 ms at 25 Hz. Stimulation will be active for 30 seconds, followed by a break of 30 seconds.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The ability of inhibitory control in an emotional Go-Nogo task
Time Frame: After 30 minutes stimulation
Analysis the behavioral and brain data recorded during the task
After 30 minutes stimulation
Oxytocin release
Time Frame: within 5 minutes after taVNS via tragus and earlobe
Investigating the oxytocin release after taVNS via tragus and earlobe based on saliva samples
within 5 minutes after taVNS via tragus and earlobe

Collaborators and Investigators

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

Sponsor

University of Electronic Science and Technology of China

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 (Actual)

May 1, 2022

Primary Completion (Actual)

July 20, 2022

Study Completion (Actual)

August 5, 2022

Study Registration Dates

First Submitted

July 15, 2022

First Submitted That Met QC Criteria

July 18, 2022

First Posted (Actual)

July 21, 2022

Study Record Updates

Last Update Posted (Estimated)

December 13, 2023

Last Update Submitted That Met QC Criteria

December 11, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • UESTC-neuSCAN-90

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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