Using a Transcutaneous Electrical Auricular Stimulator to Harness the Cholinergic Anti-Inflammatory Pathway
Completed · Not applicable · Has a placebo group
Conditions studied: Healthy Volunteers
In brief
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.
Key facts
- Study ID
- NCT02910973
- Run by
- Northwell Health
- People needed
- 16
- Starts
- 2016-09-01
- Expected to finish
- 2023-12-13
- Last updated by the study team
- 2024-02-22
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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)
Where it is running
- Feinstein Institute — Manhasset, New York, United States
Full record on ClinicalTrials.gov
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