The Effects of taVNS on Inhibitory Control

NCT ID: NCT05468385

Last Updated: 2023-12-13

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

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2022-08-05

Brief Summary

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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.

Detailed Description

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A randomized, sham-controlled, between-subject design will be employed in this study. A total of 87 healthy subjects will receive either transcutaneous vagus nerve stimulation via tragus or sham stimulation via the earlobe in the left ear. Brain activity and behavioral data for an emotional Go-Nogo task will be recorded and saliva samples will be collected before, during, and after stimulation.

Some personal traits will be assessed using different kinds of questionnaires, such as the State-Trait Anxiety Inventory (STAI), Beck's Depression Inventory(BDI), Autism Spectrum Quotient (ASQ) et al.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Tragus stimulation

Vagus nerve stimulation via tragus

Group Type EXPERIMENTAL

Vagus nerve stimulation via tragus

Intervention Type DEVICE

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.

Sham stimulation

Sham stimulation via earlobe

Group Type SHAM_COMPARATOR

Sham stimulation via earlobe

Intervention Type DEVICE

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.

Interventions

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Vagus nerve stimulation via tragus

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.

Intervention Type DEVICE

Sham stimulation via earlobe

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.

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

25 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

Locations

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University of Electronic Science and Technology of China

Chengdu, Sichuan, China

Site Status

Countries

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China

Other Identifiers

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UESTC-neuSCAN-90

Identifier Type: -

Identifier Source: org_study_id