Brain, Behavior and Endocrine Effects of Transcutaneous Vagus Nerve Stimulation

Not Applicable

• Conditions: Healthy
• Interventions: Device: Vagus nerve stimulation via tragus; Device: Sham stimulation via earlobe

• Registration Number: NCT04890457
• Lead Sponsor: University of Electronic Science and Technology of China

Brief Summary

The main aim of the study is to investigate whether the transcutaneous vagus nerve stimulation(tVNS) promotes oxytocin release and the potential biomarkers of tVNS based on eye-tracking data

Detailed Description

A randomized, single-blinded, sham-controlled, within-subject, crossover design will be employed in this study. In a randomized order, a total of 54 healthy subjects will receive transcutaneous vagus nerve stimulation via tragus and sham stimulation vis earlobe in the left ear (interval between these two stimulations will be 1 week). Eye-tracking and behavioral data will be collected before and after 30 minutes of stimulation, saliva samples will be collected before and after 30 minutes of stimulation, and the end of the experiment.

Some personal traits will be assessed using different kinds of questionnaires, such as the Autism Spectrum Quotient(ASQ), Social Responsiveness Scale(SRS), State-Trait Anxiety Inventory (STAI), Beck's Depression Inventory(BDI), and Toronto Alexithymia Scale (TAS-20).

Study Timeline

• Study Start: 2021-03-05
• Study First Submitted: 2021-05-12
• Study First Submitted QC: 2021-05-16
• Study First Posted: 2021-05-18
• Status Verified: 2021-06
• Primary Completion: 2021-06-15
• Last Update Submitted: 2021-06-28
• Last Update Posted: 2021-06-30
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 54

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Earlobe then tragus stimulation	Vagus nerve stimulation via tragus	-
Tragus then earlobe stimulation	Vagus nerve stimulation via tragus	-
Earlobe then tragus stimulation	Sham stimulation via earlobe	-
Tragus then earlobe stimulation	Sham stimulation via earlobe	-

Primary Outcome Measures

Name	Time	Method
Oxytocin release	After 30 min tragus stimulation	Investigating the oxytocin release after vagus nerve stimulation via tragus based on saliva samples

Secondary Outcome Measures

Name	Time	Method
The relationship between oxytocin concentration and personal traits	through study completion, an average of half an year	Analyzing the correlation between saliva oxytocin concentration and scores on different personal traits
Pupil size	After 30 min tragus stimulation	Investigating whether vagus nerve stimulation via tragus will increase pupil diameter

Trial Locations

Locations (1)

University of Electronic Science and Technology of China; 🇨🇳 Chengdu, Sichuan, China