Vagus Nerve Stimulation in Rheumatoid Arthritis

Northwell Health

Status and phase: Terminated; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Device: Vagus Nerve Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT00859859

GCRC 0137

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Patients with a diagnosis of RA based on the ACR guidelines. Disease activity measured as activity score (DAS-28 CRP) will be used
2. None of the exclusion criteria (see below).

Exclusion criteria

1. Minors (<18 years of age) and mentally incompetent individuals
2. 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
3. Pregnancy
4. Terminal status referred for palliative care only
5. Homeless status
6. IDDM and NIDDM patients will not be enrolled in this study
7. Previous history of ischemic cardiovascular disease including myocardial infarction, unstable angina, and bradytachyarrythmias
8. 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.
9. Smoking
10. Subjects taking concomitant medications potentially affecting autonomic function such as anti-cholinergic medications and beta-blockers.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)