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Vagus Nerve Stimulation in Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Vagus Nerve Stimulation
Sponsored by
Northwell Health
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • The Feinstein Institute for Medical Research

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 10, 2009
Last Updated
July 19, 2011
Sponsor
Northwell Health
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1. Study Identification

Unique Protocol Identification Number
NCT00859859
Brief Title
Vagus Nerve Stimulation in Rheumatoid Arthritis
Official Title
Vagus Nerve Stimulation in Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Terminated
Why Stopped
The protocol was terminated early (prior to complete enrollment) after interim analysis proved data to be statistically insignificant
Study Start Date
October 2006 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Northwell Health

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Vagus Nerve Stimulation
Intervention Description
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. Basic lab tests (metabolic panel and CBC with differential) and monocyte cytokine synthesis and other inflammatory markers will be analyzed.
Primary Outcome Measure Information:
Title
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
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin J Tracey, MD
Organizational Affiliation
The Feinstein Institute for Medical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Feinstein Institute for Medical Research
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32232095
Citation
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.
Results Reference
derived

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Vagus Nerve Stimulation in Rheumatoid Arthritis

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