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This study investigates the capacity of non-invasive vagus nerve stimulation, applied at the ear, to alter to measures of locus coeruleus output pupil diameter and EEG alpha power. Non-invasive alteration in locus coeruleus output is of interest in regard to basic science and has potential clinical implications in a number of conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Stimulation 0.5 | Experimental | 0.5mA, 30Hz intermittent transdermal vagus nerve stimulation of the auricle vagus. Stimulation 30 second on/30 seconds off for five cycles. |
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| Lobe Control | Placebo Comparator | 0.5mA, 30Hz intermittent transdermal vagus nerve stimulation of the earlobe. Stimulation 30 second on/30 seconds off for five cycles. |
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| Sham Stimulation | Placebo Comparator | 0.5mA, 5Hz intermittent transdermal vagus nerve stimulation of the auricle vagus. Stimulation 30 second on/30 seconds off for five cycles. |
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| Nonstimulation | Placebo Comparator | Placement of electrode without any stimulation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transdermal Vagus Nerve Stimulation (tVNS) | Device | Mild non-invasive transdermal electrical stimulation at the ear (0.0-1.0 mA, 0.0-30.0 Hz). Used in previous studies with no unexpected adverse events. Stimulator not considered a FDA regulated device in previous studies. |
| Measure | Description | Time Frame |
|---|---|---|
| Pupil Diameter | Pupil diameter is measured via camera. | Within single one hour session |
| EEG Alpha power. | Alpha power will be determined from EEG. | Within single one hour session |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Tech University | Russellville | Arkansas | 72801 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Aug 27, 2020 | Feb 28, 2022 | Prot_SAP_ICF_000.pdf |
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