Brain, Behavior and Endocrine Effects of Transcutaneous Vagus Nerve Stimulation

NCT ID: NCT04890457

Last Updated: 2021-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-05

Study Completion Date

2021-12-30

Brief Summary

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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

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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

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Tragus then earlobe stimulation

Group Type EXPERIMENTAL

Vagus nerve stimulation via tragus

Intervention Type DEVICE

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.

Sham stimulation via earlobe

Intervention Type DEVICE

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.

Earlobe then tragus stimulation

Group Type EXPERIMENTAL

Vagus nerve stimulation via tragus

Intervention Type DEVICE

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.

Sham stimulation via earlobe

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

28 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Electronic Science and Technology of China

OTHER

Sponsor Role lead

Responsible Party

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Keith Kendrick

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Keith Kendrick, Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Electronic Science and Technology of China

Locations

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University of Electronic Science and Technology of China

Chengdu, Sichuan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Keith Kendrick, Dr.

Role: CONTACT

86-28-61830811

Benjamin Becker, Dr.

Role: CONTACT

86-28-61830988

Facility Contacts

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Siyu Zhu, M.S.

Role: primary

86-13398406275

Qin Li, Dr.

Role: backup

86-28-61830811

Other Identifiers

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UESTC-neuSCAN-81

Identifier Type: -

Identifier Source: org_study_id

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