Brain, Behavior and Endocrine Effects of Transcutaneous Vagus Nerve Stimulation

Healthy Clinical Trial

Official title:

Transcutaneous Vagus Nerve Stimulation Promotes Oxytocin Release and Increases Fixations on Nose

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04890457
• Other study ID #: UESTC-neuSCAN-81
• Status: Recruiting
• Phase: N/A
• Start date: March 5, 2021
• Est. completion date: December 30, 2021

Study information

• Verified date: June 2021
• Source: University of Electronic Science and Technology of China
• Contact: Keith Kendrick, Dr.
• Phone: 86-28-61830811
• Email: k.kendrick.uestc[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: December 30, 2021
• Est. primary completion date: June 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 28 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• Vagus nerve stimulation via tragus
The device will send stimulus intensity around 0.5mA via tragus in the left ear (based on participants' subjective report), delivered with a pulse width of 0.25 ms at 25 Hz. Stimulation will be active for 30 seconds, followed by a break of 30 seconds.
• Sham stimulation via earlobe
The device will send stimulus intensity around 0.5mA via earlobe in the left ear (based on participants' subjective report), delivered with a pulse width of 0.25 ms at 25 Hz. Stimulation will be active for 30 seconds, followed by a break of 30 seconds.

Locations

Country	Name	City	State
China	University of Electronic Science and Technology of China	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
University of Electronic Science and Technology of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxytocin release	Investigating the oxytocin release after vagus nerve stimulation via tragus based on saliva samples	After 30 min tragus stimulation
Secondary	The relationship between oxytocin concentration and personal traits	Analyzing the correlation between saliva oxytocin concentration and scores on different personal traits	through study completion, an average of half an year
Secondary	Pupil size	Investigating whether vagus nerve stimulation via tragus will increase pupil diameter	After 30 min tragus stimulation