taVNS on Pupillary Response and Perceptual Learning

The Effect of Transcutaneous Auricular Vagal Nerve Stimulation (taVNS) on Pupillary Response and Perceptual Learning

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).

Study Overview

• Status: Completed
• Conditions: Pupillary Response
• Intervention / Treatment: Procedure: Transcutaneous Auricular Vagal Nerve Stimulation (taVNS); Procedure: Sham Stimulation

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health - Bellevue Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham	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).
Experimental: Transcutaneous Auricular Vagal Nerve Stimulation (taVNS)	Procedure: 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.
No Intervention: No Intervention (Control)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Mario Svirsky, PhD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2022
• Primary Completion (Actual): November 22, 2022
• Study Completion (Actual): July 9, 2025

Study Registration Dates

• First Submitted: May 18, 2022
• First Submitted That Met QC Criteria: May 18, 2022
• First Posted (Actual): May 23, 2022

Study Record Updates

• Last Update Posted (Estimated): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 22-00516

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No