Vagus Nerve Stimulation in Rheumatoid Arthritis

Study Overview
=================
Brief 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.

Official Title
-----------------
Vagus Nerve Stimulation in Rheumatoid Arthritis

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Device: Vagus Nerve Stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a diagnosis of RA based on the ACR guidelines. Disease activity measured as activity score (DAS-28 CRP) will be used None of the exclusion criteria (see below). Exclusion Criteria: Minors (<18 years of age) and mentally incompetent individuals One or more of the following conditions: immunosuppressive condition (which includes malignancy, chronic alcoholism, diabetes), severe chronic dementia, psychiatric illness with active psychosis, current intravenous or other serious illicit drug use Pregnancy Terminal status referred for palliative care only Homeless status IDDM and NIDDM patients will not be enrolled in this study Previous history of ischemic cardiovascular disease including myocardial infarction, unstable angina, and bradytachyarrythmias Moderate or severe anemia. Hemoglobin levels will be determined at screening. A cut-off level of < 10 mg/dL in women and < 11 mg/dL in men is selected. Smoking Subjects taking concomitant medications potentially affecting autonomic function such as anti-cholinergic medications and beta-blockers.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Vagus Nerve Stimulation|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. Basic lab tests (metabolic panel and CBC with differential) and monocyte cytokine synthesis and other inflammatory markers will be analyzed.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of short-term and medium-term effects of vagus nerve intervention with endpoints such as autonomic function, cytokine synthesis, inflammatory markers as well as disease activity score and global health measurement in subjects |  | 12 months |