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

Sponsor

Northwell Health (Other)

Overall Status

Suspended

CT.gov ID

NCT02910973

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Device: Vagus Nerve Stimulation Device: Sham Vagus Nerve Stimulation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

56 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Single (Participant)

Primary Purpose:

Other

Official Title:

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

Study Start Date :

Sep 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Vagus Nerve Stimulation 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 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 Blood will be withdrawn prior to stimulation and 1 hour following the stimulation.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 Comparator: Sham Vagus Nerve Stimulation Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes.	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.

Arm

Intervention/Treatment

Active Comparator: Vagus Nerve Stimulation

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

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 Comparator: Sham Vagus Nerve Stimulation

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

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.

Outcome Measures

Primary Outcome Measures

Lipopolysaccharide stimulated levels of TNF in whole blood. [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 Outcome Measures

Lipopolysaccharide stimulated levels of cytokines such as IL-1, IL-6, IL-8, IL-10 and HMGB1 in whole blood. [4 hours]
Whole blood will be taken from patients and stimulated by lipopolysaccharide. Levels of cytokines such as IL-1, IL-6, IL-8, IL-10 and HMGB1 that are produced by the cells in the whole blood after 4 hours of incubation will be measured.
Percentage of subjects with treatment emergent adverse events [1 hour]
The percentage of participants with treatment emergent adverse events will be assessed using the NCI-CTAEversion4.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Feinstein Institute	Manhasset	New York	United States	11030

Sponsors and Collaborators

Northwell Health

Investigators

Principal Investigator: Cynthia Aranow, MD, Northwell Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cynthia Aranow, MD, Investigator, Northwell Health

ClinicalTrials.gov Identifier:

NCT02910973

Other Study ID Numbers:

HS16-0530

First Posted:

Sep 22, 2016

Last Update Posted:

Sep 14, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Cynthia Aranow, MD, Investigator, Northwell Health

Inflammation, Vagus Nerve Stimulation

Study Results

No Results Posted as of Sep 14, 2021