Using a Transcutaneous Electrical Auricular Stimulator to Harness the Cholinergic Anti-Inflammatory Pathway
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Northwell Health
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Lipopolysaccharide stimulated levels of TNF in whole blood.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
Arms & Interventions
Vagus Nerve Stimulation
Device: Vagus nerve stimulation Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes.
Intervention: Vagus Nerve Stimulation (Device)
Sham Vagus Nerve Stimulation
Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes.
Intervention: Sham Vagus Nerve Stimulation (Device)
Outcomes
Primary Outcomes
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
- Percentage of subjects with treatment emergent adverse events(1 hour)
- Lipopolysaccharide stimulated levels of cytokines such as IL-1, IL-6, IL-8, IL-10 and HMGB1 in whole blood.(4 hours)
Investigators
Cynthia Aranow, MD
Investigator
Northwell Health