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Completed

NCT Number: NCT05386563

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).

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Key information

Conditions

Pupillary Response

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health - Bellevue Hospital

New York, 10016, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Sham stimulation

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).

Primary outcomes

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

    Time frame: Baseline, Month 3

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

  2. Change in Overall Mean Peak (Pupillary Response)

    Time frame: Baseline, Month 3

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

  3. Change in Speed of Learning to Perform a Behavioral Task

    Time frame: Baseline, Month 3

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

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2025
First posted
May 23, 2022
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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