NCT05386563

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

May 18, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 23, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2022

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2025

Completed
Last Updated

December 17, 2025

Status Verified

December 1, 2025

Enrollment Period

6 months

First QC Date

May 18, 2022

Last Update Submit

December 9, 2025

Conditions

Pupillary Response

Outcome Measures

Primary Outcomes (3)

  • Change in Time It Takes to Reach 90% of Asymptotic Level Performance

    Will be measured during performance on a go/no-go task.

    Baseline, Month 3

  • Change in Overall Mean Peak (Pupillary Response)

    Pupillary responses will be measured noninvasively using a video camera during a go/no-go task.

    Baseline, Month 3

  • Change in Speed of Learning to Perform a Behavioral Task

    Will be measured during performance on a go/no-go task.

    Baseline, Month 3

Study Arms (3)

Transcutaneous Auricular Vagal Nerve Stimulation (taVNS)

EXPERIMENTAL
Procedure: Transcutaneous Auricular Vagal Nerve Stimulation (taVNS)

Sham

SHAM COMPARATOR
Procedure: Sham Stimulation

No Intervention (Control)

NO INTERVENTION

Interventions

Transcutaneous Auricular Vagal Nerve Stimulation (taVNS)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.

Transcutaneous Auricular Vagal Nerve Stimulation (taVNS)
Sham StimulationPROCEDURE

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).

Sham

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy individuals 18 to 65
  • Normal audiometric testing

You may not qualify if:

  • Co-morbidities including cardiomyopathies, arrhythmias
  • Implantable devices including vagal stimulators, pacemakers
  • Presence of metallic implants
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Health - Bellevue Hospital

New York, New York, 10016, United States

Location

Study Officials

  • Mario Svirsky, PhD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2022

First Posted

May 23, 2022

Study Start

May 18, 2022

Primary Completion

November 22, 2022

Study Completion

July 9, 2025

Last Updated

December 17, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Access Criteria
Researchers who provide a methodologically sound proposal will have access to the data upon reasonable request. Requests should be directed to mario.svirsky@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US(1)