NCT05468385

Brief Summary

The main aim of the study is to investigate whether the transcutaneous vagus nerve stimulation(tVNS) improves the ability of inhibitory control in an emotional Go-Nogo task.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 15, 2022

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 21, 2022

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2022

Completed
Last Updated

December 13, 2023

Status Verified

December 1, 2023

Enrollment Period

3 months

First QC Date

July 15, 2022

Last Update Submit

December 11, 2023

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • The ability of inhibitory control in an emotional Go-Nogo task

    Analysis the behavioral and brain data recorded during the task

    After 30 minutes stimulation

  • Oxytocin release

    Investigating the oxytocin release after taVNS via tragus and earlobe based on saliva samples

    within 5 minutes after taVNS via tragus and earlobe

Study Arms (2)

Tragus stimulation

EXPERIMENTAL

Vagus nerve stimulation via tragus

Device: Vagus nerve stimulation via tragus

Sham stimulation

SHAM COMPARATOR

Sham stimulation via earlobe

Device: Sham stimulation via earlobe

Interventions

Vagus nerve stimulation via tragusDEVICE

The device will send stimulus intensity of around 0.5mA via tragus in the left ear (based on participants' subjective report), delivered with a pulse width of 0.5 ms at 25 Hz. Stimulation will be active for 30 seconds, followed by a break of 30 seconds.

Tragus stimulation
Sham stimulation via earlobeDEVICE

The device will send stimulus intensity of around 0.5mA via the earlobe in the left ear (based on participants' subjective reports), delivered with a pulse width of 0.5 ms at 25 Hz. Stimulation will be active for 30 seconds, followed by a break of 30 seconds.

Sham stimulation

Eligibility Criteria

Age18 Years - 25 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 15, 2022

First Posted

July 21, 2022

Study Start

May 1, 2022

Primary Completion

July 20, 2022

Study Completion

August 5, 2022

Last Updated

December 13, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)