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

Phase 1

Completed

• Conditions: Cytokine Response to Vagus Nerve Stimulation
• Interventions: Device: Vagus Nerve Stimulator

• Registration Number: NCT01569789
• Lead Sponsor: Northwell Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-03-30
• Study First Submitted QC: 2012-03-30
• Study First Posted: 2012-04-03
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-14
• Last Update Posted: 2015-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ear Stimulation	Vagus Nerve Stimulator	Comparing cytokine levels pre and post stimulation of the nerve in the ear
Calf Stimulation	Vagus Nerve Stimulator	Comparing cytokine levels pre and post stimulation of the placebo area on the calf

Primary Outcome Measures

Name	Time	Method
TNF levels in the ex vivo LPS-stimulated whole blood	30 minutes (or 5 days) post stimulation

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Feinstein Institute for Medical Research; 🇺🇸 Manhasset, New York, United States