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

NCT ID: NCT02910973

Last Updated: 2024-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2023-12-13

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Vagus Nerve Stimulation

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

Group Type: ACTIVE_COMPARATOR

Vagus Nerve Stimulation

Intervention Type: 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 Blood will be withdrawn prior to stimulation and 1 hour following the stimulation.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.

Sham Vagus Nerve Stimulation

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

Group Type: SHAM_COMPARATOR

Sham Vagus Nerve Stimulation

Intervention Type: 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 Blood will be withdrawn prior to stimulation and 1 hour following the stimulation.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.

Interventions

Vagus Nerve Stimulation

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.

Intervention Type: DEVICE

Sham Vagus Nerve Stimulation

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.

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Northwell Health

OTHER

Sponsor Role: lead

Responsible Party

Cynthia Aranow, MD

Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cynthia Aranow, MD

Role: PRINCIPAL_INVESTIGATOR

Northwell Health

Locations

Feinstein Institute

Manhasset, New York, United States

Countries

United States

Other Identifiers

HS16-0530

Identifier Type: -

Identifier Source: org_study_id