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Safety and Efficacy Vagal Nerve Stimulation in Patients With Rheumatoid Arthritis

NCT01552941 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2016-11-01

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Cyberonics VNS System

Active Implantable Electrical Vagal Nerve Stimulator

Sponsors & Collaborators

  • SetPoint Medical Corporation

    lead INDUSTRY

Principal Investigators

  • Paul-Peter Tak, M.D., Ph.D. · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2014-03-31
Completion
2014-05-31

Countries

  • Bosnia and Herzegovina
  • Croatia
  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01552941 on ClinicalTrials.gov