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taVNS on Pupillary Response and Perceptual Learning

NCT ID: NCT05386563

Last Updated: 2025-12-17

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

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-18

Study Completion Date

2025-07-09

Brief Summary

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This study has two parts. The study team will evaluate transcutaneous auricular vagal nerve stimulation (taVNS) and two sham settings during a passive task while measuring pupillary response. Second, the study team will assign either taVNS, sham, or no intervention during a go/no-go task and evaluate perceptual learning over three sessions which will also include measuring the pupillary response and electroencephalogram (EEG).

Detailed Description

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Conditions

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Pupillary Response

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Transcutaneous Auricular Vagal Nerve Stimulation (taVNS)

Group Type EXPERIMENTAL

Transcutaneous Auricular Vagal Nerve Stimulation (taVNS)

Intervention Type PROCEDURE

taVNS will be delivered by Digitimer DS7 Constant Current Stimulator (an FDA cleared medical device intended for human nerve and muscle stimulation).

Stimulation is delivered via sticky pad electrodes all placed on the left side of the body (cymba concha, earlobe, and ulnar side of the wrist). Stimulation is delivered by a 3000ms pulse train (100us pulse width and 25Hz stimulation frequency). The current applied will be between 0.01uA to 9uA. The intervention will be delivered over the course of four sessions approximately one week apart.

Sham

Group Type SHAM_COMPARATOR

Sham Stimulation

Intervention Type PROCEDURE

Sham stimulation will be delivered by Digitimer DS7 Constant Current Stimulator (an FDA cleared medical device intended for human nerve and muscle stimulation).

Stimulation is delivered via sticky pad electrodes all placed on the left side of the body (either earlobe or forearm).

No Intervention (Control)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Transcutaneous Auricular Vagal Nerve Stimulation (taVNS)

taVNS will be delivered by Digitimer DS7 Constant Current Stimulator (an FDA cleared medical device intended for human nerve and muscle stimulation).

Stimulation is delivered via sticky pad electrodes all placed on the left side of the body (cymba concha, earlobe, and ulnar side of the wrist). Stimulation is delivered by a 3000ms pulse train (100us pulse width and 25Hz stimulation frequency). The current applied will be between 0.01uA to 9uA. The intervention will be delivered over the course of four sessions approximately one week apart.

Intervention Type PROCEDURE

Sham Stimulation

Sham stimulation will be delivered by Digitimer DS7 Constant Current Stimulator (an FDA cleared medical device intended for human nerve and muscle stimulation).

Stimulation is delivered via sticky pad electrodes all placed on the left side of the body (either earlobe or forearm).

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Healthy individuals 18 to 65
* Normal audiometric testing

Exclusion Criteria

* Co-morbidities including cardiomyopathies, arrhythmias
* Implantable devices including vagal stimulators, pacemakers
* Presence of metallic implants
* Pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mario Svirsky, PhD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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NYU Langone Health - Bellevue Hospital

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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22-00516

Identifier Type: -

Identifier Source: org_study_id