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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2015-01-31

Brief Summary

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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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Detailed Description

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Conditions

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Cytokine Response to Vagus Nerve Stimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Ear Stimulation

Comparing cytokine levels pre and post stimulation of the nerve in the ear

Group Type ACTIVE_COMPARATOR

Vagus Nerve Stimulator

Intervention Type DEVICE

Voltage 2, placed on cymba concha

Calf Stimulation

Comparing cytokine levels pre and post stimulation of the placebo area on the calf

Group Type PLACEBO_COMPARATOR

Vagus Nerve Stimulator

Intervention Type DEVICE

Voltage 2, place on the placebo area of the calf

Interventions

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Vagus Nerve Stimulator

Voltage 2, placed on cymba concha

Intervention Type DEVICE

Vagus Nerve Stimulator

Voltage 2, place on the placebo area of the calf

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes