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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcutaneous Auricular Vagal Nerve Stimulation (taVNS) | Experimental |
| |
| Sham | Sham Comparator |
| |
| No Intervention (Control) | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Time It Takes to Reach 90% of Asymptotic Level Performance | Will be measured during performance on a go/no-go task. | 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. | Baseline, Month 3 |
| Change in Speed of Learning to Perform a Behavioral Task | Will be measured during performance on a go/no-go task. | Baseline, Month 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mario Svirsky, PhD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health - Bellevue Hospital | New York | New York | 10016 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Researchers who provide a methodologically sound proposal will have access to the data upon reasonable request. Requests should be directed to mario.svirsky@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
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| 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). |
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