Vagus Nerve Stimulation in Rheumatoid Arthritis

NCT ID: NCT00859859

Last Updated: 2011-07-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2009-02-28

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.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Northwell Health

OTHER

Sponsor Role: lead

Responsible Party

The Feinstein Institute for Medical Research

Principal Investigators

Kevin J Tracey, MD

Role: PRINCIPAL_INVESTIGATOR

Northwell Health

Locations

The Feinstein Institute for Medical Research

Manhasset, New York, United States

Countries

United States

References

Addorisio ME, Imperato GH, de Vos AF, Forti S, Goldstein RS, Pavlov VA, van der Poll T, Yang H, Diamond B, Tracey KJ, Chavan SS. Investigational treatment of rheumatoid arthritis with a vibrotactile device applied to the external ear. Bioelectron Med. 2019 Apr 17;5:4. doi: 10.1186/s42234-019-0020-4. eCollection 2019.

Reference Type: DERIVED

PMID: 32232095 (View on PubMed)

Other Identifiers

GCRC 0137

Identifier Type: -

Identifier Source: org_study_id