NCT01569789

Brief Summary

The autonomic (self-regulating) nervous system is important for the function of many organs in the body. The vagus nerve is part of the autonomic nervous system. The vagus nerve carries incoming information from the nervous system to the brain, providing information about what the body is doing, and it also transmits outgoing information which governs a range of reflex responses. It plays an important role in the immune system. A part of the vagus nerve is reachable for stimulation at specific locations in the ear. The purpose of this study is to better understand how different ways of stimulating the vagus nerve at the ear can affect a chemical marker of inflammation found in human blood that is associated with a variety of inflammatory diseases such as rheumatoid arthritis and lupus. This information may lead to in future studies to see if stimulation of the vagus nerve can improve inflammation in chronic inflammatory diseases.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2012

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 3, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

April 15, 2015

Status Verified

April 1, 2015

Enrollment Period

3 years

First QC Date

March 30, 2012

Last Update Submit

April 14, 2015

Conditions

Cytokine Response to Vagus Nerve Stimulation

Keywords

cytokinesinflammationvagus nerveTNF

Outcome Measures

Primary Outcomes (1)

  • TNF levels in the ex vivo LPS-stimulated whole blood

    30 minutes (or 5 days) post stimulation

Secondary Outcomes (1)

  • IL-1B, IL-6, IL-8 and IL-10 levels will also be determined by using the same assay

    30 minutes (or 5 days) post stimulation

Study Arms (2)

Ear Stimulation

ACTIVE COMPARATOR

Comparing cytokine levels pre and post stimulation of the nerve in the ear

Device: Vagus Nerve Stimulator

Calf Stimulation

PLACEBO COMPARATOR

Comparing cytokine levels pre and post stimulation of the placebo area on the calf

Device: Vagus Nerve Stimulator

Interventions

Vagus Nerve StimulatorDEVICE

Voltage 2, placed on cymba concha

Ear Stimulation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Between 18 and 60 years old
  • Currently healthy with no medical problems
  • Non-smoker

You may not qualify if:

  • History of any of the following: cardiac arrhythmia, coronary artery disease, chronic inflammatory disease, anemia, malignancy, depression, connective tissue disease (arthritis, vasculitis), neurologic disease, diabetes mellitus, renal disease, malignancy, dementia, psychiatric illness including active psychosis, or any other chronic medical condition
  • Use of cholinergic, anti-cholinergic, or beta-blocking medications
  • Family history of inflammatory disease
  • Pregnancy
  • Smoking
  • Ear infection (otitis media or externa)
  • Implanted vagus nerve stimulator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Feinstein Institute for Medical Research

Manhasset, New York, 11030, United States

Location

Related Publications (1)

  • Addorisio ME, Imperato GH, de Vos AF, Forti S, Goldstein RS, Pavlov VA, van der Poll T, Yang H, Diamond B, Tracey KJ, Chavan SS. Investigational treatment of rheumatoid arthritis with a vibrotactile device applied to the external ear. Bioelectron Med. 2019 Apr 17;5:4. doi: 10.1186/s42234-019-0020-4. eCollection 2019.

    PMID: 32232095DERIVED

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kevin J Tracey, MD

    Northwell Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2012

First Posted

April 3, 2012

Study Start

January 1, 2012

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

April 15, 2015

Record last verified: 2015-04

Locations

US(1)