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Vercise Implantable Stimulator for Treating Parkinson's Disease (VANTAGE)

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ClinicalTrials.gov Identifier: NCT01221948
Recruitment Status : Completed
First Posted : October 18, 2010
Results First Posted : November 13, 2015
Last Update Posted : August 27, 2018
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Tracking Information
First Submitted Date  ICMJE October 8, 2010
First Posted Date  ICMJE October 18, 2010
Results First Submitted Date  ICMJE July 27, 2015
Results First Posted Date  ICMJE November 13, 2015
Last Update Posted Date August 27, 2018
Study Start Date  ICMJE October 2010
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 14, 2015)
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). [ Time Frame: 26 weeks post first lead implantation ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 14, 2010)
Change in the motor score of the Unified Parkinson's Disease Rating Scale (UPDRS) [ Time Frame: 26 weeks post first lead implantation ]
Change History Complete list of historical versions of study NCT01221948 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 16, 2018)
  • Mean Change in UPDRS III Score From Baseline Meds Off to 12 and 52 Weeks Post First Lead Implantation Stim on/Meds Off. [ Time Frame: 12 and 52 weeks post first lead implantation ]
    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.
  • Mean Change in UPDRS II Score From Baseline Meds Off to 12, 26 and 52 Weeks Post First Lead Implantation Stim on/Meds Off. [ Time Frame: 12, 26 and 52 weeks post first lead implantation ]
    Unified Parkinson's Disease Rating Scale Part II (UPDRS II) is a sub-section of the Unified Parkinson's Disease Rating scale designed to evaluate Activities of Daily Living. This section contains 13 items. Each item is scored on a scale from 0 (normal) to 4 (disabled), with the total score for the 13 items ranging from 0 to 52.
  • Mean Change in Antiparkinsonian Medication Use in Mgs (Levodopa or Equivalents) From Baseline to 12, 26 and 52 Weeks Post First Lead Implantation [ Time Frame: 12, 26 and 52 weeks post first lead implantation ]
    All parkinsonian medications will be converted to Levodopa dose equivalents (LED) and baseline dose will be compared with dose taken at 12, 26 and 52 weeks post 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. [ Time Frame: 12, 26 and 52 weeks post first lead implantation ]
    Subjects will complete a 3-day motor diary prior to study visits. At one-hour increments (during waking hours), patients will record "on", "on with troublesome dyskinesia", "off", and "asleep" times for three consecutive days.
  • 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. [ Time Frame: 12, 26 and 52 weeks post first lead implantation ]
    The Parkinson's Disease Questionnaire (PDQ-39) is a 39-item questionnaire designed to measure the specific impact of PD on quality of life. The questions measure the impact on health-related quality of life along 8 dimensions:
    • mobility
    • activities of daily living
    • emotional well-being
    • stigma
    • social support
    • cognitions
    • communication
    • bodily discomfort. Dimension scores range from 0 to 100, with 0 representing perfect health for the measure and 100 representing worst health for the measure.
  • Mean Percent Change in Quality of Life Scale Scores: Modified Schwab and England (SE) Scores From Baseline Meds on to 12, 26 and 52 Weeks Post First Lead Implantation Stim on/Meds on [ Time Frame: 12, 26 and 52 weeks post first lead implantation ]
    The purpose of the Schwab and England (SE) (13) single-item scale is to quantify a PD patients' ability to perform activities of daily living. The single item is based on a percentage rating with scores in 10% increments. Scores range from 0% (completely bed-ridden) to 100% (completely independent).
  • Percentage of Participants With Improved, No Change or Worsened Global Impression of Change (GIC) as Compared to Baseline, Evaluated by the Neurologist. [ Time Frame: 52 weeks post first lead implantation ]
    Global Impression of Change (GIC) is a comparison to baseline and will be evaluated by rating the global impression of change using a seven-point scale: ("very much improved" to "marked worsening"). This assessment was completed by the neurologist.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2010)
  • Number of participants with adverse events (AEs), including serious adverse events (SAEs), as a measure of Safety [ Time Frame: 52 weeks post first lead implantation ]
  • Change in the motor score of the Unified Parkinson's Disease Rating Scale (UPDRS) [ Time Frame: 12 weeks post first lead implantation ]
  • Change in the mentation, behavior, and mood scores of the UPDRS [ Time Frame: 12 weeks post first lead implantation ]
  • Change in antiparkinsonian medication use [ Time Frame: 12 weeks post first lead implantation ]
  • Change in hand-arm movement test score [ Time Frame: 12 weeks post first lead implantation ]
  • Change in tremor rating scale [ Time Frame: 12 weeks post first lead implantation ]
  • Change in the dyskinesia rating scale score [ Time Frame: 12 weeks post first lead implantation ]
  • Change in the number of waking hours per day with good symptom control and no troublesome dyskinesia [ Time Frame: 12 weeks post first lead implantation ]
  • Change in quality of life scale scores [ Time Frame: 12 weeks post first lead implantation ]
    Short Form Health Survey (SF-36), Parkinson's Disease Questionnaire (PDQ-39) and modified Schwab and England (SE)
  • Change in the Global Impression of Change Scale (GIC) rating score [ Time Frame: 12 weeks post first lead implantation ]
  • Changes in resource utilization [ Time Frame: 12 weeks post first lead implantation ]
  • Change in freezing of gait episodes [ Time Frame: 12 weeks post first lead implantation ]
  • Change in the motor score of the Unified Parkinson's Disease Rating Scale (UPDRS) [ Time Frame: 52 weeks post first lead implantation ]
  • Change in the mentation, behavior, and mood scores of the UPDRS [ Time Frame: 26 weeks post first lead implantation ]
  • Change in the mentation, behavior, and mood scores of the UPDRS [ Time Frame: 52 weeks post first lead implantation ]
  • Change in the activities of daily living score of the UPDRS [ Time Frame: 12 weeks post first lead implantation ]
  • Change in the activities of daily living score of the UPDRS [ Time Frame: 26 weeks post first lead implantation ]
  • Change in the activities of daily living score of the UPDRS [ Time Frame: 52 weeks post first lead implantation ]
  • Change in the therapy complication score of the UPDRS [ Time Frame: 12 weeks post first lead implantation ]
  • Change in the therapy complication score of the UPDRS [ Time Frame: 26 weeks post first lead implantation ]
  • Change in the therapy complication score of the UPDRS [ Time Frame: 52 weeks post first lead implantation ]
  • Change in the overall score of the UPDRS [ Time Frame: 12 weeks post first lead implantation ]
  • Change in the overall score of the UPDRS [ Time Frame: 26 weeks post first lead implantation ]
  • Change in the overall score of the UPDRS [ Time Frame: 52 weeks post first lead implantation ]
  • Change in antiparkinsonian medication use [ Time Frame: 26 weeks post first lead implantation ]
  • Change in antiparkinsonian medication use [ Time Frame: 52 weeks post first lead implantation ]
  • Change in hand-arm movement test score [ Time Frame: 26 weeks post first lead implantation ]
  • Change in hand-arm movement test score [ Time Frame: 52 weeks post first lead implantation ]
  • Change in walking test score [ Time Frame: 12 weeks post first lead implantation ]
  • Change in walking test score [ Time Frame: 26 weeks post first lead implantation ]
  • Change in walking test score [ Time Frame: 52 weeks post first lead implantation ]
  • Change in tremor rating scale [ Time Frame: 26 weeks post first lead implantation ]
  • Change in tremor rating scale [ Time Frame: 52 weeks post first lead implantation ]
  • Change in the dyskinesia rating scale score [ Time Frame: 26 weeks post first lead implantation ]
  • Change in the dyskinesia rating scale score [ Time Frame: 52 weeks post first lead implantation ]
  • Change in the number of waking hours per day with good symptom control and no troublesome dyskinesia [ Time Frame: 26 weeks post first lead implantation ]
  • Change in the number of waking hours per day with good symptom control and no troublesome dyskinesia [ Time Frame: 52 weeks post first lead implantation ]
  • Change in quality of life scale scores [ Time Frame: 26 weeks post first lead implantation ]
    Short Form Health Survey (SF-36), Parkinson's Disease Questionnaire (PDQ-39) and modified Schwab and England (SE)
  • Change in quality of life scale scores [ Time Frame: 52 weeks post first lead implantation ]
    Short Form Health Survey (SF-36), Parkinson's Disease Questionnaire (PDQ-39) and modified Schwab and England (SE)
  • Change in the Global Impression of Change Scale (GIC) rating score [ Time Frame: 26 weeks post first lead implantation ]
  • Change in the Global Impression of Change Scale (GIC) rating score [ Time Frame: 52 weeks post first lead implantation ]
  • Changes in resource utilization [ Time Frame: 26 weeks post first lead implantation ]
  • Changes in resource utilization [ Time Frame: 52 weeks post first lead implantation ]
  • Change in freezing of gait episodes [ Time Frame: 26 weeks post first lead implantation ]
  • Change in freezing of gait episodes [ Time Frame: 52 weeks post first lead implantation ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vercise Implantable Stimulator for Treating Parkinson's Disease
Official Title  ICMJE VANTAGE STUDY Vercise™ Implantable Stimulator for Treating Parkinson's Disease
Brief Summary 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).
Detailed Description This is a multi-center, prospective, open label, non-randomized study which will use a within-patient control (each patient serves as his/her own control) 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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Boston Scientific Vercise Deep Brain Stimulation system will be implanted and each patient will serve as its own control.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Idiopathic Parkinson's Disease
Intervention  ICMJE Device: Deep Brain Stimulation
Rechargeable Deep Brain Stimulation System
Study Arms  ICMJE Experimental: Deep Brain Stimulation
Rechargeable Deep Brain Stimulation System
Intervention: Device: Deep Brain Stimulation
Publications * Timmermann L, Jain R, Chen L, Maarouf M, Barbe MT, Allert N, Brücke T, Kaiser I, Beirer S, Sejio F, Suarez E, Lozano B, Haegelen C, Vérin 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 14, 2015)
53
Original Estimated Enrollment  ICMJE
 (submitted: October 14, 2010)
40
Actual Study Completion Date  ICMJE June 1, 2018
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  1. Diagnosis of bilateral idiopathic PD with the presence of at least 2 of the following: resting tremor, rigidity, or bradykinesia.
  2. Duration of bilateral idiopathic PD of more than five years.
  3. Stable medications
  4. UPDRS subset III score of ≥30 without medication.
  5. Lack of dementia or depression.
  6. Must improve with antiparkinsonian medication, but have some motor complications that are not well controlled by medications.
  7. Must be an appropriate candidate for the surgical procedures required for bilateral STN DBS.
  8. Is willing and able to comply with all visits and study related procedures
  9. Patient understands the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.

Key Exclusion Criteria:

  1. Any intracranial abnormality or medical condition that would contraindicate DBS surgery.
  2. Any finding in neuropsychological screening assessments that would contraindicate DBS surgery, including dementia.
  3. Any significant psychiatric problems, including unrelated clinically significant depression.
  4. Any current drug or alcohol abuse.
  5. Any history of recurrent or unprovoked seizures.
  6. Frequent falls while receiving good medication therapy without dyskinesias (on-state).
  7. Any prior movement disorder treatments that involved intracranial surgery or device implantation.
  8. Any other active implanted device.
  9. Any previous brain surgery that would interfere with the placement of the leads or the functioning of the device.
  10. A history of neurostimulation intolerance in any area of the body.
  11. A condition requiring or likely to require the use of magnetic resonance imaging (MRI) or diathermy.
  12. Currently on any anticoagulant medications that can not be discontinued during perioperative period.
  13. Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints, including any terminal illness with survival <12 months.
  14. Participation in another drug, device, or biologics trial concurrently or within the preceding 30 days. Any other trial participation should be approved by the Principal Investigators.
  15. A female that is breastfeeding or of child bearing potential with a positive urine pregnancy test or not using adequate contraception.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   France,   Germany,   Italy,   Spain,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01221948
Other Study ID Numbers  ICMJE A5001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boston Scientific Corporation
Study Sponsor  ICMJE Boston Scientific Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lars Timmermann, M.D. Uniklinik Köln, Germany
Principal Investigator: François Alesch, M.D. Allgemeines Krankenhaus AKH, Vienna, Austria
PRS Account Boston Scientific Corporation
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP