Pupillary Response
Conditions
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).
Interventions
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.
PROCEDURESham 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).
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Time It Takes to Reach 90% of Asymptotic Level Performance | Baseline, Month 3 | Will be measured during performance on a go/no-go task. |
| Change in Overall Mean Peak (Pupillary Response) | 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 | Baseline, Month 3 | Will be measured during performance on a go/no-go task. |
Countries
United States
Outcome results
None listed