50 Participants Needed

taVNS for Pupillary Response

MS
Overseen ByMario Svirsky, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: NYU Langone Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

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).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment taVNS for Pupillary Response?

Research shows that taVNS can affect pupil size, which is a promising sign of vagal nerve activation. Additionally, taVNS has been used to help with heart rate regulation and gastric issues, suggesting it may have broader effects on the body's systems.12345

Is transcutaneous auricular vagus nerve stimulation (taVNS) safe for humans?

Transcutaneous auricular vagus nerve stimulation (taVNS) is generally considered safe for humans, with only mild and temporary side effects like ear pain, headache, and tingling. A large review of studies found no serious adverse events linked to taVNS, making it a safe option for clinical use.23456

How is the treatment taVNS unique compared to other treatments for pupillary response?

taVNS is unique because it uses low-intensity electrical currents applied to the ear to stimulate the vagus nerve, which is different from other treatments that might not target this nerve or use electrical stimulation. This approach is being explored for its potential effects on pupil size, which is a novel area of research.12345

Research Team

MS

Mario Svirsky, PhD

Principal Investigator

NYU Langone Health

Eligibility Criteria

This trial is for healthy individuals aged 18 to 65 with normal hearing. It's not suitable for those with heart muscle diseases, irregular heartbeats, implanted devices like pacemakers or vagal stimulators, metallic implants in their body, or pregnant women.

Inclusion Criteria

Normal audiometric testing
I am between 18 and 65 years old and healthy.

Exclusion Criteria

Presence of metallic implants
Pregnancy
I have heart conditions like cardiomyopathy or irregular heartbeats.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcutaneous auricular vagal nerve stimulation (taVNS) or sham during a passive task and a go/no-go task to evaluate perceptual learning and pupillary response over three sessions

3 months
3 sessions

Follow-up

Participants are monitored for changes in speed of learning and pupillary response after treatment

4 weeks

Treatment Details

Interventions

  • Sham Stimulation
  • Transcutaneous Auricular Vagal Nerve Stimulation (taVNS)
Trial OverviewThe study is testing the effects of transcutaneous auricular vagal nerve stimulation (taVNS) on how the pupil responds and on learning during a task that requires quick decisions. Participants will be compared across three groups: taVNS, sham (fake) stimulation, and no intervention.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Transcutaneous Auricular Vagal Nerve Stimulation (taVNS)Experimental Treatment1 Intervention
Group II: No Intervention (Control)Active Control1 Intervention
Group III: ShamPlacebo Group1 Intervention

Transcutaneous Auricular Vagal Nerve Stimulation (taVNS) is already approved in European Union, United States for the following indications:

🇪🇺
Approved in European Union as taVNS for:
  • Epilepsy
  • Depression
  • Chronic Pain
  • Anxiety
🇺🇸
Approved in United States as taVNS for:
  • Depression
  • Anxiety

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Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+

Findings from Research

In a study with 66 healthy participants, transcutaneous auricular vagus nerve stimulation (taVNS) did not significantly affect markers of noradrenergic activity, despite expectations that it would enhance this activity.
The results indicated that continuous taVNS stimulation at the tested parameters was ineffective in modulating both phasic and tonic noradrenergic responses, suggesting that this method may not be a viable approach for increasing noradrenergic activity through vagal pathways.
No evidence for a modulating effect of continuous transcutaneous auricular vagus nerve stimulation on markers of noradrenergic activity.D'Agostini, M., Burger, AM., Villca Ponce, G., et al.[2022]
Transcutaneous auricular vagus nerve stimulation (taVNS) can induce significant pupil dilation in healthy subjects, particularly at a stimulation intensity of 2 mA under scotopic lighting conditions.
The study highlights that the effects of taVNS are influenced by specific stimulation parameters and the experimental setup, indicating the need for careful consideration in future research.
The effects of transcutaneous auricular vagal nerve stimulation on pupil size.Capone, F., Motolese, F., Di Zazzo, A., et al.[2021]
Transcutaneous auricular Vagus Nerve Stimulation (taVNS) can be optimized by varying electrode designs, which significantly affects the sensitivity and selectivity of nerve activation in different regions of the ear, as shown through a detailed anatomical model and finite element analysis.
The study found that smaller electrodes increase the electric field strength for a given current, allowing for more targeted stimulation of specific ear regions, which is crucial for enhancing the efficacy of taVNS in clinical applications.
High-resolution computational modeling of the current flow in the outer ear during transcutaneous auricular Vagus Nerve Stimulation (taVNS).Kreisberg, E., Esmaeilpour, Z., Adair, D., et al.[2023]

References

No evidence for a modulating effect of continuous transcutaneous auricular vagus nerve stimulation on markers of noradrenergic activity. [2022]
The effects of transcutaneous auricular vagal nerve stimulation on pupil size. [2021]
High-resolution computational modeling of the current flow in the outer ear during transcutaneous auricular Vagus Nerve Stimulation (taVNS). [2023]
Transcutaneous Auricular Vagus Nerve Stimulation Normalizes Induced Gastric Myoelectrical Dysrhythmias in Controls Assessed by Body-Surface Gastric Mapping. [2023]
Short trains of transcutaneous auricular vagus nerve stimulation (taVNS) have parameter-specific effects on heart rate. [2020]
Safety of transcutaneous auricular vagus nerve stimulation (taVNS): a systematic review and meta-analysis. [2023]