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Completed

NCT Number: NCT01569789

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

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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Key information

Conditions

Cytokine Response to Vagus Nerve Stimulation Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Feinstein Institute for Medical Research

Manhasset, New York, 11030, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vagus nerve stimulator

Device

Voltage 2, placed on cymba concha

Primary outcomes

  1. TNF levels in the ex vivo LPS-stimulated whole blood

    Time frame: 30 minutes (or 5 days) post stimulation

Secondary outcomes

  1. IL-1B, IL-6, IL-8 and IL-10 levels will also be determined by using the same assay

    Time frame: 30 minutes (or 5 days) post stimulation

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Apr 3, 2012
Registry last updated
Apr 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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