Clinical trial NCT01569789: Effects of Auricular Vagus Nerve Stimulation on the Pro-inflammatory Cytokine Response in Healthy Adults
Official title: Effects of Auricular Vagus Nerve Stimulation on the Pro-inflammatory Cytokine Response in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cytokine Response to Vagus Nerve Stimulation
Keywords: cytokines
inflammation
vagus nerve
TNF
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2012-04-03
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: TNF levels in the ex vivo LPS-stimulated whole blood
timeFrame: 30 minutes (or 5 days) post stimulation
Secondary outcomes:
measure: IL-1B, IL-6, IL-8 and IL-10 levels will also be determined by using the same assay
timeFrame: 30 minutes (or 5 days) post stimulation
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: Feinstein Institute for Medical Research
state: New York
Study officials:
affiliation: Northwell Health
name: Kevin J Tracey, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.