Vagus Nerve Stimulation in Rheumatoid Arthritis

Stopped early · Phase 1

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT00859859

Run by

Northwell Health

People needed

23

Starts

2006-10-01

Expected to finish

2009-02-01

Last updated by the study team

2011-07-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• The Feinstein Institute for Medical Research — Manhasset, New York, United States

Full record on ClinicalTrials.gov

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