Vercise Implantable Stimulator for Treating Parkinson's Disease
VANTAGE
VANTAGE STUDY Vercise™ Implantable Stimulator for Treating Parkinson's Disease
Sponsor study identifier
interventional
53
6 countries
7
Study Start
October 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2013
Actual (reported)Study Completion
June 1, 2018
Actual (reported)The purpose of this study is to document patient outcomes, including effectiveness, safety, and health economic data, for the Boston Scientific implantable deep brain stimulation (DBS) Vercise™ system for bilateral stimulation of the subthalamic nucleus (STN) in the treatment of moderate to severe idiopathic Parkinson's Disease (PD).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 1, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2010
Date type not reportedThis date has not been verified as actual or estimated.
October 8, 2010
Actual (reported)October 18, 2010
Actual (reported)May 2013
Actual (reported)November 13, 2015
Actual (reported)June 1, 2018
Actual (reported)Mean Change in UPDRS III Score From Baseline in the Meds Off Condition (no Medications) to 26 Weeks Post First Lead Implantation in the Stim on/Meds Off Condition (Stimulation on and no Medications).
Unified Parkinson's Disease Rating Scale Part III (UPDRS III) is the motor sub-section of the Unified Parkinson's Disease Rating scale designed to evaluate overall motor disability, including the classic symptoms of Parkinson's Disease. This section has 14 items. Each item is scored on a scale from 0 (normal) to 4 (severe, marked, or unable), with the total possible score for the 14 items, including separate questions regarding symptoms present axially and in appendages, ranging from 0 to 108 with lower scores representing better results.
26 weeks post first lead implantation
Mean Change in UPDRS III Score From Baseline Meds Off to 12 and 52 Weeks Post First Lead Implantation Stim on/Meds Off.
12 and 52 weeks post first lead implantation
Mean Change in UPDRS II Score From Baseline Meds Off to 12, 26 and 52 Weeks Post First Lead Implantation Stim on/Meds Off.
12, 26 and 52 weeks post first lead implantation
Mean Change in Antiparkinsonian Medication Use in Mgs (Levodopa or Equivalents) From Baseline to 12, 26 and 52 Weeks Post First Lead Implantation
12, 26 and 52 weeks post first lead implantation
Mean Change in the Number of Waking Hours Per Day With Good Symptom Control and no Troublesome Dyskinesia From Baseline to 12, 26 and 52 Weeks Post First Lead Implantation.
12, 26 and 52 weeks post first lead implantation
Mean Percent Change in Quality of Life Scale Scores: Parkinson's Disease Questionnaire (PDQ-39) From Baseline Meds on to 12, 26 and 52 Weeks Post First Lead Implantation Stim on/Meds on.
12, 26 and 52 weeks post first lead implantation
Rechargeable Deep Brain Stimulation System
Rechargeable Deep Brain Stimulation System
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Allgemeines Krankenhaus AKH
Vienna, Austria
CHU de Rennes-Pontchaillou
Rennes, France
Uniklinik Köln
Cologne, Germany
IRCCS Istituto Ortopedico Galeazzi
Milan, Italy
Hospital Central de Asturias
Oviedo, Spain
Frenchay Hospital
Bristol, United Kingdom
Southmead Hospital Bristol
Bristol, United Kingdom
Timmermann L, Jain R, Chen L, Maarouf M, Barbe MT, Allert N, Brucke T, Kaiser I, Beirer S, Sejio F, Suarez E, Lozano B, Haegelen C, Verin M, Porta M, Servello D, Gill S, Whone A, Van Dyck N, Alesch F. Multiple-source current steering in subthalamic nucleus deep brain stimulation for Parkinson's disease (the VANTAGE study): a non-randomised, prospective, multicentre, open-label study. Lancet Neurol. 2015 Jul;14(7):693-701. doi: 10.1016/S1474-4422(15)00087-3. Epub 2015 May 28.
Lars Timmermann, M.D.
Universitätsklinikum Köln
François Alesch, M.D.
Allgemeines Krankenhaus AKH, Vienna, Austria
53 participants (actual enrollment reported by the registry).
First Submitted
October 8, 2010
First Posted
October 18, 2010
Study Start
October 2010
Date type not reportedEffect of Deep Brain Stimulation on Gait of Patients With Parkinson's Disease Depending on Electrode Location in Subthalamic Area
Effect of Deep Brain Stimulation on Gastrointestinal (GI) Motility
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This date has not been verified as actual or estimated.
Primary Completion
May 2013
Actual (reported)Study Completion
June 1, 2018
Actual (reported)Last Updated
February 5, 2025
Results First Posted
November 13, 2015
Record last verified: 2025-02
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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