Brain, Behavior and Endocrine Effects of Transcutaneous Vagus Nerve Stimulation

Sponsor
University of Electronic Science and Technology of China (Other)
Overall Status
Recruiting
CT.gov ID
NCT04890457
Collaborator
(none)
54
1
2
9.9
5.5

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Device: Vagus nerve stimulation via tragus
  • Device: Sham stimulation via earlobe
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
54 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Transcutaneous Vagus Nerve Stimulation Promotes Oxytocin Release and Increases Fixations on Nose
Actual Study Start Date :
Mar 5, 2021
Actual Primary Completion Date :
Jun 15, 2021
Anticipated Study Completion Date :
Dec 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tragus then earlobe stimulation

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.

Experimental: Earlobe then tragus stimulation

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.

Outcome Measures

Primary Outcome Measures

  1. Oxytocin release [After 30 min tragus stimulation]

    Investigating the oxytocin release after vagus nerve stimulation via tragus based on saliva samples

Secondary Outcome Measures

  1. 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

  2. Pupil size [After 30 min tragus stimulation]

    Investigating whether vagus nerve stimulation via tragus will increase pupil diameter

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 28 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Electronic Science and Technology of China Chengdu Sichuan China 611731

Sponsors and Collaborators

  • University of Electronic Science and Technology of China

Investigators

  • Principal Investigator: Keith Kendrick, Dr., University of Electronic Science and Technology of China

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Keith Kendrick, Professor, University of Electronic Science and Technology of China
ClinicalTrials.gov Identifier:
NCT04890457
Other Study ID Numbers:
  • UESTC-neuSCAN-81
First Posted:
May 18, 2021
Last Update Posted:
Jun 30, 2021
Last Verified:
Jun 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Keith Kendrick, Professor, University of Electronic Science and Technology of China

Study Results

No Results Posted as of Jun 30, 2021