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The autonomic (self-regulating) nervous system is important for the function of many organs in the body. The vagus nerve is part of the autonomic nervous system. The vagus nerve carries incoming information from the nervous system to the brain, providing information about what the body is doing, and it also transmits outgoing information which governs a range of reflex responses. It plays an important role in the immune system. A part of the vagus nerve is reachable for stimulation at specific locations in the ear.
The purpose of this study is to better understand how different ways of stimulating the vagus nerve at the ear can affect a chemical marker of inflammation found in human blood that is associated with a variety of inflammatory diseases such as rheumatoid arthritis and lupus. This information may lead to in future studies to see if stimulation of the vagus nerve can improve inflammation in chronic inflammatory diseases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ear Stimulation | Active Comparator | Comparing cytokine levels pre and post stimulation of the nerve in the ear |
|
| Calf Stimulation | Placebo Comparator | Comparing cytokine levels pre and post stimulation of the placebo area on the calf |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vagus Nerve Stimulator | Device | Voltage 2, placed on cymba concha |
| |
| Measure | Description | Time Frame |
|---|---|---|
| TNF levels in the ex vivo LPS-stimulated whole blood | 30 minutes (or 5 days) post stimulation |
| Measure | Description | Time Frame |
|---|---|---|
| IL-1B, IL-6, IL-8 and IL-10 levels will also be determined by using the same assay | 30 minutes (or 5 days) post stimulation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin J Tracey, MD | Northwell Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Feinstein Institute for Medical Research | Manhasset | New York | 11030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32232095 | Derived | Addorisio ME, Imperato GH, de Vos AF, Forti S, Goldstein RS, Pavlov VA, van der Poll T, Yang H, Diamond B, Tracey KJ, Chavan SS. Investigational treatment of rheumatoid arthritis with a vibrotactile device applied to the external ear. Bioelectron Med. 2019 Apr 17;5:4. doi: 10.1186/s42234-019-0020-4. eCollection 2019. |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Vagus Nerve Stimulator |
| Device |
Voltage 2, place on the placebo area of the calf |
|