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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Northwell Health
ClinicalTrials.gov Identifier:
NCT01569789
First received: March 30, 2012
Last updated: April 14, 2015
Last verified: April 2015
  Purpose

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.


Condition Intervention Phase
Cytokine Response to Vagus Nerve Stimulation
Device: Vagus Nerve Stimulator
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Auricular Vagus Nerve Stimulation on the Pro-inflammatory Cytokine Response in Healthy Adults

Further study details as provided by Northwell Health:

Primary Outcome Measures:
  • TNF levels in the ex vivo LPS-stimulated whole blood [ Time Frame: 30 minutes (or 5 days) post stimulation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: January 2012
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ear Stimulation
Comparing cytokine levels pre and post stimulation of the nerve in the ear
Device: Vagus Nerve Stimulator
Voltage 2, placed on cymba concha
Placebo Comparator: Calf Stimulation
Comparing cytokine levels pre and post stimulation of the placebo area on the calf
Device: Vagus Nerve Stimulator
Voltage 2, place on the placebo area of the calf

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01569789

Locations
United States, New York
Feinstein Institute for Medical Research
Manhasset, New York, United States, 11030
Sponsors and Collaborators
Northwell Health
Investigators
Principal Investigator: Kevin J Tracey, MD Northwell Health
  More Information

Responsible Party: Northwell Health
ClinicalTrials.gov Identifier: NCT01569789     History of Changes
Other Study ID Numbers: Vagus-1 
Study First Received: March 30, 2012
Last Updated: April 14, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Northwell Health:
cytokines
inflammation
vagus nerve
TNF

ClinicalTrials.gov processed this record on July 27, 2016