Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
18 participants
INTERVENTIONAL
2012-01-31
2018-10-31
Brief Summary
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Detailed Description
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Patients who complete study SPM-005 will be enrolled in this study at the time of the last visit of the preceding study. The assessments at the last visit of the preceding study will also be used as baseline measures for the current study. If the patient has previously discontinued SPM-005 and greater than 30 days have elapsed since the final visit in SPM-005, baseline measures for the current study will be repeated, and an interim medical history will be taken to assess whether any new medical conditions were diagnosed in the time between studies.
Follow-up visits will occur at 3, 6, 12, 18, 24, 36 and 48 months. A final follow-up visit will occur for all remaining patients at study closure when the final enrolled subject has completed 48 months on study.
The study will continue until the last patient entered has completed 48 months in this study.
An Interim Visit or a phone contact must be performed a maximum of 2 months after any change in device settings. Interim visits may also be performed at any time at the investigator's discretion; either between scheduled visits, or after the patient has completed the Month 48 Visit, if the study is still ongoing.
The primary efficacy objective is to determine the long term efficacy of vagal nerve stimulation as assessed by the DAS28 score.
The secondary efficacy objectives are to determine the long term efficacy of vagal nerve stimulation as assessed by:
* the ACR 20, 50 and 70 response rate,
* the EULAR response rate, and
* changes in the Euro-QoL score.
The safety objectives are to determine the long term safely of vagal nerve stimulation as assessed by the subject incidence rates of:
* Adverse events
* Serious adverse events
* Device deficiencies
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cyberonics VNS System
Continued stimulation w/Cyberonics VNS
Cyberonics VNS System
Stimulation with an active implantable electrical vagal nerve stimulation device
Interventions
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Cyberonics VNS System
Stimulation with an active implantable electrical vagal nerve stimulation device
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Significant psychiatric illness or substance abuse
18 Years
75 Years
ALL
No
Sponsors
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SetPoint Medical Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Ralph Zitnik, M.D.
Role: STUDY_DIRECTOR
SetPoint Medical
Locations
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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
Countries
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Other Identifiers
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SPM-006
Identifier Type: -
Identifier Source: org_study_id