Brain, Behavior and Endocrine Effects of Transcutaneous Vagus Nerve Stimulation

University of Electronic Science and Technology of China

Status: Unknown

Conditions: Healthy

Treatments: Device: Sham stimulation via earlobe; Device: Vagus nerve stimulation via tragus

Study type: Interventional

Funder types: Other

Identifiers

NCT04890457

UESTC-neuSCAN-81

Details and patient eligibility

About

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

Full 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).

Enrollment: 54 estimated patients

Sex: All

Ages: 18 to 28 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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54 participants in 2 patient groups

Tragus then earlobe stimulation

Experimental group

Treatment:

Device: Sham stimulation via earlobe

Device: Vagus nerve stimulation via tragus

Earlobe then tragus stimulation

Experimental group

Treatment:

Device: Sham stimulation via earlobe

Device: Vagus nerve stimulation via tragus