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

NCT01569789 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2015-04-15

No results posted yet for this study

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.

Conditions

  • Cytokine Response to Vagus Nerve Stimulation

Interventions

DEVICE

Vagus Nerve Stimulator

Voltage 2, placed on cymba concha

DEVICE

Vagus Nerve Stimulator

Voltage 2, place on the placebo area of the calf

Sponsors & Collaborators

  • Northwell Health

    lead OTHER

Principal Investigators

  • Kevin J Tracey, MD · Northwell Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01569789 on ClinicalTrials.gov