Clinical trial NCT02910973: Using a Transcutaneous Electrical Auricular Stimulator to Harness the Cholinergic Anti-Inflammatory Pathway
Official title: Using a Transcutaneous Electrical Auricular Stimulator to Harness the Cholinergic Anti-Inflammatory Pathway
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: Inflammation, Vagus Nerve Stimulation
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2016-09-22
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Lipopolysaccharide stimulated levels of TNF in whole blood.
timeFrame: 4 hours
Secondary outcomes:
measure: Lipopolysaccharide stimulated levels of cytokines such as IL-1, IL-6, IL-8, IL-10 and HMGB1 in whole blood.
timeFrame: 4 hours
measure: Percentage of subjects with treatment emergent adverse events
timeFrame: 1 hour
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: Feinstein Institute
state: New York
Study officials:
affiliation: Northwell Health
name: Cynthia Aranow, MD
role: PRINCIPAL_INVESTIGATOR
References: