NCT04890457

Brain, Behavior and Endocrine Effects of Transcutaneous Vagus Nerve Stimulation

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: University of Electronic Science and Technology of China · Academic / Other
• Sex: All
• Age: 18 Years – 28 Years
• Healthy volunteers: Accepted

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).

Conditions

• Healthy

Interventions

Type	Name	Description
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.
DEVICE	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.

Timeline

• Start date: 2021-03-05
• Primary completion: 2021-06-15
• Completion: 2021-12-30
• First posted: 2021-05-18
• Last updated: 2021-06-30

Locations

1 site across 1 country: China