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| ID | Type | Description | Link |
|---|---|---|---|
| 23-0265 | Other Identifier | Northwell Health |
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| Name | Class |
|---|---|
| Northwell Health | OTHER |
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This study is designed as a randomized, double-blind, sham-controlled, single-center research study in which healthy adults will be randomized 1:1 into one of two experimental groups, to receive transcutaneous auricular vagus nerve stimulation (taVNS) targeting either the auricular branch of the vagus nerve (ABVN) or tAN, which targets the ABVN and the auriculotemporal nerve (ATN):
Participants will receive 30 minutes of sham stimulation (taVNS or tAN), followed by active stimulation (taVNS or tAN). Blood biomarkers (local and systemic) will be measured before and at several timepoints after stimulation to measure the molecular and cellular effects of the device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) | Experimental |
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| Transcutaneous Auricular Neurostimulation (tAN) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Volta System | Device | The Volta System is a wearable, battery-operated, neurostimulation system designed to deliver tAN or taVNS. The device will be used to deliver two 30-minute sessions of active or sham therapy according to the participant's randomization group (taVNS or tAN). |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarker of hemostasis (tissue anti-thrombin (TAT) complex) in blood shed from fingerstick | Mean TAT levels in shed blood after active stimulation versus sham stimulation within each group | From collection up to 240 minutes, assessed upon receipt of assay results (up to one month) |
| Biomarker of hemostasis (tissue anti-thrombin (TAT) complex) in blood shed from fingerstick | Percent change in TAT levels in shed blood after active stimulation between groups (taVNS vs tAN) | From collection up to 240 minutes, assessed upon receipt of assay results (up to one month) |
| Biomarkers of hemostasis (TAT complex, D-dimer, viscoelasticity, coagulation tests (prothrombin time (PT), partial thromboplastin time (PTT)) in circulating blood | Mean coagulation biomarker levels in circulating blood after active stimulation versus sham stimulation within each group | From collection up to 240 minutes, assessed upon receipt of assay results (up to one month) |
| Biomarkers of hemostasis (TAT complex, D-dimer, viscoelasticity, coagulation tests (prothrombin time (PT), partial thromboplastin time (PTT)) in circulating blood | Percent change in coagulation biomarker levels in circulating blood after active stimulation between groups ( taVNS vs tAN) | From collection up to 240 minutes, assessed upon receipt of assay results (up to one month) |
| Biomarkers of inflammation (tumor necrosis factor (TNF), and interleukin (IL)-1B and IL-6) in circulating whole blood stimulated ex vivo with lipopolysaccharide (LPS) | Mean inflammation biomarker levels in LPS-stimulated whole blood after active stimulation versus sham stimulation within each group | From collection up to 240 minutes, assessed upon receipt of assay results (up to one month) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Feinstein Institutes for Medical Research | Manhasset | New York | 11030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42243989 | Derived | Huston JM, Bravo-Iniguez CE, Papoin J, Ahmad M, Le B, Mirro I, McWade M, Benner C, Covalin A, Czura CJ, Khodaparast N, Blanc L. Effects of transcutaneous auricular vagus nerve stimulation or combined vagal and trigeminal nerve stimulation on platelet function and laboratory hemostasis parameters in healthy human subjects. Bioelectron Med. 2026 Jun 5;12(1):14. doi: 10.1186/s42234-026-00208-w. |
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Participants will be randomized into two 30-minute stimulation sessions. One session will be active and the other sham. Participants are blinded to treatment group as well as the stimulation session.
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| Biomarkers of inflammation (tumor necrosis factor (TNF), and interleukin (IL)-1B and IL-6) in circulating whole blood stimulated ex vivo with lipopolysaccharide (LPS) | Percent change in inflammation biomarker levels in LPS-stimulated whole blood after active stimulation between groups (taVNS vs tAN) | From collection up to 240 minutes, assessed upon receipt of assay results (up to one month) |