Vagus Nerve Stimulation in Rheumatoid Arthritis

• Sponsor: Northwell Health (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00859859
• Collaborator: (none)
• Enrollment: 23
• Location: 1
• Duration (Months): 28.1
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Device: Vagus Nerve Stimulation	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 23 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Vagus Nerve Stimulation in Rheumatoid Arthritis
• Study Start Date: Oct 1, 2006
• Actual Primary Completion Date: Feb 1, 2009
• Actual Study Completion Date: Feb 1, 2009

Outcome Measures

Primary Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Feinstein Institute for Medical Research	Manhasset	New York	United States	11030

Sponsors and Collaborators

• Northwell Health

Investigators

• Principal Investigator: Kevin J Tracey, MD, The Feinstein Institute for Medical Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00859859
• Other Study ID Numbers: GCRC 0137
• First Posted: Mar 11, 2009
• Last Update Posted: Jul 20, 2011
• Last Verified: Jul 1, 2011

• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid

Study Results

No Results Posted as of Jul 20, 2011