Effects of Auricular Vagus Nerve Stimulation on the Pro-inflammatory Cytokine Response in Healthy Adults

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Effects of Auricular Vagus Nerve Stimulation on the Pro-inflammatory Cytokine Response in Healthy Adults

Conditions
-----------------
Cytokine Response to Vagus Nerve Stimulation

Intervention / Treatment
-----------------
* Device: Vagus Nerve Stimulator
* Device: Vagus Nerve Stimulator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between 18 and 60 years old Currently healthy with no medical problems Non-smoker Exclusion Criteria: History of any of the following: cardiac arrhythmia, coronary artery disease, chronic inflammatory disease, anemia, malignancy, depression, connective tissue disease (arthritis, vasculitis), neurologic disease, diabetes mellitus, renal disease, malignancy, dementia, psychiatric illness including active psychosis, or any other chronic medical condition Use of cholinergic, anti-cholinergic, or beta-blocking medications Family history of inflammatory disease Pregnancy Smoking Ear infection (otitis media or externa) Implanted vagus nerve stimulator

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ear Stimulation<br>Comparing cytokine levels pre and post stimulation of the nerve in the ear | Device: Vagus Nerve Stimulator<br>* Voltage 2, placed on cymba concha<br>|
| Placebo Comparator: Calf Stimulation<br>Comparing cytokine levels pre and post stimulation of the placebo area on the calf | Device: Vagus Nerve Stimulator<br>* Voltage 2, place on the placebo area of the calf<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TNF levels in the ex vivo LPS-stimulated whole blood |  | 30 minutes (or 5 days) post stimulation | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cytokines, inflammation, vagus nerve, TNF