The Effects of taVNS on Inhibitory Control

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: Healthy
• Intervention / Treatment: Device: Vagus nerve stimulation via tragus; Device: Sham stimulation via earlobe

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	Analysis the behavioral and brain data recorded during the task	After 30 minutes stimulation
Oxytocin release	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

• Sponsor: University of Electronic Science and Technology of China

Study record dates

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