Status:
TERMINATED
Vagus Nerve Stimulation in Rheumatoid Arthritis
Lead Sponsor:
Northwell Health
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ea...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00859859
Start Date
October 1 2006
End Date
February 1 2009
Last Update
July 20 2011
Active Locations (1)
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1
The Feinstein Institute for Medical Research
Manhasset, New York, United States, 11030