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Safety and Efficacy Vagal Nerve Stimulation in Patients With Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01552941
Recruitment Status : Completed
First Posted : March 13, 2012
Last Update Posted : November 1, 2016
Information provided by (Responsible Party):
SetPoint Medical Corporation

Brief Summary:
This is a 12 week open label pilot study to determine the efficacy and safety of a surgically implanted, electrically active vagal nerve stimulation device in patients with active rheumatoid arthritis.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Device: Cyberonics VNS System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of the Safety and Efficacy of Neurostimulation of the Cholinergic Anti-Inflammatory Pathway Using an Active Implantable Vagal Nerve Stimulation Device in Patients With Rheumatoid Arthritis
Study Start Date : July 2011
Actual Primary Completion Date : March 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Vagal Nerve Stimulation Device: Cyberonics VNS System
Active Implantable Electrical Vagal Nerve Stimulator

Primary Outcome Measures :
  1. Change in DAS from baseline [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Number of patients with ACR 20 response [ Time Frame: 6 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult-onset rheumatoid arthritis of at least six months duration as defined by the 2010 ACR/EULAR classification criteria (Aletaha, 2010)
  • Male or female patients, 18-75 years of age, inclusive
  • Functional status I, II, or III as classified according to the ACR 1991 revised criteria (Hochberg, 1992)
  • Patients must have active disease as defined by at least 4 active tender or swollen joints and CRP above 0.7 mg/dL, despite at least 3 months of treatment with methotrexate at a dose of up to 25 mg orally per week.
  • Patients may have been previously treated with TNF antagonists, but must have failed by reason of inadequate safety, intolerance to side effects, or development of antibodies (i.e., secondary failures), and specifically cannot have failed on the basis of primary lack of efficacy
  • Study amended to add a second cohort of up to 10 patients who have failed both a TNF antagonist and at least one other biological therapy having a non-TNF antagonist mechanism of action

Exclusion Criteria:

  • History of unilateral or bilateral vagotomy
  • History of recurrent vaso-vagal syncope episodes
  • Known obstructive sleep apnea
  • Known history of cardiac rhythm disturbances, atrio-ventricular block of greater than first degree, or cardiac conduction pathway abnormalities other than isolated right bundle branch block or isolated left anterior fascicle block
  • Significant pharyngeal dysfunction or swallowing difficulties
  • Pre-existing clinically significant vocal cord damage or hoarseness
  • Previously implanted electrically active medical devices (e.g., cardiac pacemakers, automatic implantable cardioverter-defibrillators)
  • Asthma or chronic obstructive pulmonary disease not controlled by medications, or any other disease causing clinically significant dyspnea at time of screening
  • Active peptic ulcer disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01552941

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Bosnia and Herzegovina
Sveučilišna klinička bolnica Mostar
Mostar, Bosnia and Herzegovina
Klinicki Centar Univerziteta, Reumatologija
Sarajevo, Bosnia and Herzegovina
Sisters of Mercy Clinical Hospital Centre
Zagreb, Croatia
Academic Medical Center, University of Amsterdam
Amsterdam, Netherlands
Sponsors and Collaborators
SetPoint Medical Corporation
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Principal Investigator: Paul-Peter Tak, M.D., Ph.D. Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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Responsible Party: SetPoint Medical Corporation Identifier: NCT01552941    
Other Study ID Numbers: SPM-005
First Posted: March 13, 2012    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by SetPoint Medical Corporation:
Vagus Nerve
Vagal Nerve Stimulation
Rheumatoid Arthritis
Implantable Medical Device
Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases