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



Status:Recruiting
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 60
Updated:3/16/2019
Start Date:September 2016
End Date:December 2019
Contact:Sanita Kandasami
Email:SKandasami@Northwell.edu
Phone:516 562-2401

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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.


Inclusion Criteria:

1. Age between 18-60 years,

2. Currently healthy with no medical problems

3. Able and willing to give written informed consent and comply with the requirements of
the study protocol.

Exclusion Criteria:

1. 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.

2. Family history of inflammatory disease

3. Treatment with an anti-cholinergic medication, including over the counter medications,

4. Implantable electronic devices such as pacemakers, defibrillators, hearing aids,
cochlear implants or deep brain stimulators.

5. Current tobacco or nicotine user (to limit potential confounding effects of exposure
to nicotine),

6. Chronic inflammatory disorders

7. 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,

8. Any condition which, in the opinion of the investigator, would jeopardize the
subject's safety following exposure to a study intervention,

9. Pregnancy or lactation (Pregnancy status & lactation will be determined via
self-report),

10. Implanted vagus nerve stimulator

11. Inability to comply with study procedures

12. Ear infection (otitis media or externa)
We found this trial at
1
site
Manhasset, New York 11030
Principal Investigator: Cynthia Aranow, M.D.
Phone: 516-562-2401
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mi
from
Manhasset, NY
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