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

NCT02910973 | Completed

• 1 other identifier: HS16-0530
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Inflammation, Vagus Nerve Stimulation

Outcome Measures

Primary Outcomes (1)

• Lipopolysaccharide stimulated levels of TNF in whole blood.

  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.

  4 hours

Secondary Outcomes (2)

• Lipopolysaccharide stimulated levels of cytokines such as IL-1, IL-6, IL-8, IL-10 and HMGB1 in whole blood.

  4 hours

• Percentage of subjects with treatment emergent adverse events

  1 hour

Study Arms (2)

Vagus Nerve Stimulation

ACTIVE COMPARATOR

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

Device: Vagus Nerve Stimulation

Sham Vagus Nerve Stimulation

SHAM COMPARATOR

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

Device: Sham Vagus Nerve Stimulation

Interventions

Vagus Nerve Stimulation DEVICE

Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes. Blood will be withdrawn prior to stimulation and 1 hour following the stimulation. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch of the vagus nerve.

Vagus Nerve Stimulation

Sham Vagus Nerve Stimulation DEVICE

Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes. Blood will be withdrawn prior to stimulation and 1 hour following the stimulation. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve.

Sham Vagus Nerve Stimulation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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)

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Feinstein Institute

Manhasset, New York, 11030, United States

Location

MeSH Terms

Conditions

Inflammation

Interventions

Vagus Nerve Stimulation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics

Study Officials

• Cynthia Aranow, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: September 20, 2016
• First Posted: September 22, 2016
• Study Start: September 1, 2016
• Primary Completion: December 13, 2023
• Study Completion: December 13, 2023
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)