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Completed

NCT Number: NCT02910973

Using a Transcutaneous Electrical Auricular Stimulator to Harness the Cholinergic Anti-Inflammatory Pathway

Persistent chronic inflammation is an important underlying event in multiple diseases including rheumatoid arthritis, inflammatory bowel diseases and type 2 diabetes. These disorders are characterized as inflammatory in part because of the important mediating role of pro-inflammatory cytokines in their pathogenesis. This study will investigate whether transcutaneous auricular electrical stimulation of the vagus nerve will affect and decrease the inflammatory cytokine response in healthy individuals.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Feinstein Institute

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

  • Age between 18-60 years,
  • Currently healthy with no medical problems
  • Able and willing to give written informed consent and comply with the requirements of the study protocol.

Exclusion criteria

  • History of any of the following: cardiac arrhythmia, coronary artery disease, autoimmune disease, chronic inflammatory disease, anemia, malignancy, depression, neurologic disease, diabetes mellitus, renal disease, malignancy, dementia, psychiatric illness including active psychosis, or any other chronic medical condition.
  • Family history of inflammatory disease
  • Treatment with an anti-cholinergic medication, including over the counter medications,
  • Implantable electronic devices such as pacemakers, defibrillators, hearing aids, cochlear implants or deep brain stimulators.
  • Current tobacco or nicotine user (to limit potential confounding effects of exposure to nicotine),
  • Chronic inflammatory disorders
  • Investigational drug and/or treatment during the 28 days or seven half-lives of the investigational drug prior to the start of study drug dosing (Day 0), whichever is the greater length of time,
  • Any condition which, in the opinion of the investigator, would jeopardize the subject's safety following exposure to a study intervention,
  • Pregnancy or lactation (Pregnancy status & lactation will be determined via self-report),
  • Implanted vagus nerve stimulator
  • Inability to comply with study procedures
  • Ear infection (otitis media or externa)

Treatment and study plan

vagus nerve stimulation

Device

Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes. Blood will be withdrawn prior to stimulation and 1 hour following the stimulation. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch of the vagus nerve.

Sham vagus nerve stimulation

Device

Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes. Blood will be withdrawn prior to stimulation and 1 hour following the stimulation. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve.

Primary outcomes

  1. Lipopolysaccharide stimulated levels of TNF in whole blood.

    Time frame: 4 hours

    Whole blood will be taken from patients and stimulated by lipopolysaccharide. Levels of TNF produced by the cells in the whole blood after 4 hours of incubation will be measured.

Secondary outcomes

  1. Lipopolysaccharide stimulated levels of cytokines such as IL-1, IL-6, IL-8, IL-10 and HMGB1 in whole blood.

    Time frame: 4 hours

    Whole blood will be taken from patients and stimulated by lipopolysaccharide. Levels of cytokines such as IL-1, IL-6, IL-8, IL-10 and HMGB1 that are produced by the cells in the whole blood after 4 hours of incubation will be measured.

  2. Percentage of subjects with treatment emergent adverse events

    Time frame: 1 hour

    The percentage of participants with treatment emergent adverse events will be assessed using the NCI-CTAEversion4.

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Registry information

Acronym: TEACAP

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Sep 22, 2016
Registry last updated
Feb 22, 2024

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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