Brain, Behavior and Endocrine Effects of Transcutaneous Vagus Nerve Stimulation
Transcutaneous Vagus Nerve Stimulation Promotes Oxytocin Release and Increases Fixations on Nose
1 other identifier
interventional
54
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable healthy
Started Mar 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 5, 2021
CompletedFirst Submitted
Initial submission to the registry
May 12, 2021
CompletedFirst Posted
Study publicly available on registry
May 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2021
CompletedJune 30, 2021
June 1, 2021
3 months
May 12, 2021
June 28, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Oxytocin release
Investigating the oxytocin release after vagus nerve stimulation via tragus based on saliva samples
After 30 min tragus stimulation
Secondary Outcomes (2)
The relationship between oxytocin concentration and personal traits
through study completion, an average of half an year
Pupil size
After 30 min tragus stimulation
Study Arms (2)
Tragus then earlobe stimulation
EXPERIMENTALEarlobe then tragus stimulation
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- Healthy subjects without past or current psychiatric or neurological disorders
You may not qualify if:
- history of head injury;
- pregnant, menstruating, taking oral contraceptives;
- medical or psychiatric illness.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Electronic Science and Technology of China
Chengdu, Sichuan, 611731, China
Study Officials
- PRINCIPAL INVESTIGATOR
Keith Kendrick, Dr.
University of Electronic Science and Technology of China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 12, 2021
First Posted
May 18, 2021
Study Start
March 5, 2021
Primary Completion
June 15, 2021
Study Completion
December 30, 2021
Last Updated
June 30, 2021
Record last verified: 2021-06