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Brain, Behavior and Endocrine Effects of Transcutaneous Vagus Nerve Stimulation

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04890457
Enrollment
54
Registered
2021-05-18
Start date
2021-03-05
Completion date
2021-12-30
Last updated
2021-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Transcutaneous vagus nerve stimulation, Oxytocin release, Eye-tracking

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).

Interventions

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.

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.

Sponsors

University of Electronic Science and Technology of China
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 28 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Oxytocin releaseAfter 30 min tragus stimulationInvestigating the oxytocin release after vagus nerve stimulation via tragus based on saliva samples

Secondary

MeasureTime frameDescription
The relationship between oxytocin concentration and personal traitsthrough study completion, an average of half an yearAnalyzing the correlation between saliva oxytocin concentration and scores on different personal traits
Pupil sizeAfter 30 min tragus stimulationInvestigating whether vagus nerve stimulation via tragus will increase pupil diameter

Countries

China

Contacts

Primary ContactKeith Kendrick, Dr.
k.kendrick.uestc@gmail.com86-28-61830811
Backup ContactBenjamin Becker, Dr.
ben_becker@gmx.de86-28-61830988

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026