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Vagus Nerve Stimulation in Rheumatoid Arthritis

NCT00859859 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2011-07-20

No results posted yet for this study

Summary

The purpose of this study is to examine the short-term effects of vagus nerve stimulation (VNS) by auricular stimulation (stimulation of the auricular branch of the vagus nerve which innervates the ear) in rheumatoid arthritis (RA). RA is characterized by a chronic systemic inflammation affecting the joints but also carries an increased risk for extra-articular manifestations as well as other organ manifestations such as cardiovascular disease (CVD), which significantly contributes to morbidity and mortality in this disorder.

Conditions

Interventions

DEVICE

Vagus Nerve Stimulation

1. Vagus nerve stimulation for 5 minutes with an oscillatory device (Brookstone) used in previous experimental animal studies for stimulating the vagus nerve on the neck by carotid massage. The oscillatory part of this pen-like device is approximately 0,5 cm2. 2. Basic lab tests (metabolic panel and CBC with differential) and monocyte cytokine synthesis and other inflammatory markers will be analyzed.

Sponsors & Collaborators

  • Northwell Health

    lead OTHER

Principal Investigators

  • Kevin J Tracey, MD · Northwell Health

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2009-02-28
Completion
2009-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00859859 on ClinicalTrials.gov