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Clinical Trials/NCT05386563
NCT05386563CompletedNot Applicable

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

NYU Langone Health1 site in 1 country12 target enrollmentStarted: May 18, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
12
Locations
1
Primary Endpoint
Change in Time It Takes to Reach 90% of Asymptotic Level Performance

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

No Intervention (Control)

No Intervention

Transcutaneous Auricular Vagal Nerve Stimulation (taVNS)

Experimental

Intervention: Transcutaneous Auricular Vagal Nerve Stimulation (taVNS) (Procedure)

Sham

Sham Comparator

Intervention: Sham Stimulation (Procedure)

Outcomes

Primary Outcomes

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 Speed of Learning to Perform a Behavioral Task

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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