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

Northwell Health

Status: Completed

Conditions: Healthy Volunteers

Treatments: Device: Sham Vagus Nerve Stimulation; Device: Vagus Nerve Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02910973

HS16-0530

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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16 participants in 2 patient groups

Vagus Nerve Stimulation

Active Comparator group

Description:

Device: Vagus nerve stimulation Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes.

Treatment:

Device: Vagus Nerve Stimulation

Sham Vagus Nerve Stimulation

Sham Comparator group

Description:

Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes.

Treatment:

Device: Sham Vagus Nerve Stimulation