Pupillary ResponseNCT05386563
taVNS on Pupillary Response and Perceptual Learning
A study testing Transcutaneous Auricular Vagal Nerve Stimulation (taVNS) in people with Pupillary Response, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pupillary Response
- What is being tested?
- Transcutaneous Auricular Vagal Nerve Stimulation (taVNS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2022to 9 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy individuals 18 to 65
- Normal audiometric testing
Who cannot join
- Co-morbidities including cardiomyopathies, arrhythmias
- Implantable devices including vagal stimulators, pacemakers
- Presence of metallic implants
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
NYU Langone Health - Bellevue Hospital
New York, New York, 10016
About this study
Official title: 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).
- Conditions
- Pupillary Response
- Being tested
- Transcutaneous Auricular Vagal Nerve Stimulation (taVNS), Sham Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Auricular Vagal Nerve Stimulation (taVNS)Procedure or surgery
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 StimulationProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous Auricular Vagal Nerve Stimulation (taVNS) | Experimental | Not described Receives: Procedure: Transcutaneous Auricular Vagal Nerve Stimulation (taVNS) |
| Sham | Sham comparator | Not described Receives: Procedure: Sham Stimulation |
| No Intervention (Control) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Time It Takes to Reach 90% of Asymptotic Level Performance
Will be measured during performance on a go/no-go task.
Measured: 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.
Measured: Baseline, Month 3
Change in Speed of Learning to Perform a Behavioral Task
Will be measured during performance on a go/no-go task.
Measured: Baseline, Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start18 May 2022
- Primary completion22 Nov 2022
- Study completion9 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pupillary ResponseStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mario Svirsky, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05386563
- Sponsor's protocol ID
- 22-00516
- Status last verified
- Dec 2025
- First submitted
- 18 May 2022
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Transcutaneous Auricular Vagal Nerve Stimulation (taVNS) on Pupillary Response and Perceptual Learning
- ClinicalTrials.gov ID
- NCT05386563
- Acronym / sponsor ID
- 22-00516
- Conditions
- Pupillary Response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 18 May 2022 (actual)
- Primary completion
- 22 Nov 2022 (actual)
- Study completion
- 9 Jul 2025 (actual)
- First posted
- 23 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy individuals 18 to 65
- Normal audiometric testing
Key exclusion criteria (4 listed)
- Co-morbidities including cardiomyopathies, arrhythmias
- Implantable devices including vagal stimulators, pacemakers
- Presence of metallic implants
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Transcutaneous Auricular Vagal Nerve Stimulation (taVNS) |
| Sham StimulationSham 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). | Procedure or surgery | Sham |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mario Svirsky, PhD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Auricular Vagal Nerve Stimulation (taVNS) in people with Pupillary Response, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Time It Takes to Reach 90% of Asymptotic Level Performance (time frame: Baseline, Month 3). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025; AzTrials last refreshed its copy on 31 Oct 2026.