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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01221948
First received: October 8, 2010
Last updated: November 23, 2015
Last verified: July 2015
  Purpose
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).

Condition Intervention Phase
Idiopathic Parkinson's Disease
Device: Deep Brain Stimulation
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: VANTAGE STUDY Vercise™ Implantable Stimulator for Treating Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    All parkinsonian medications will be converted to Levodopa dose equivalents (LED)

  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 53
Study Start Date: October 2010
Estimated Study Completion Date: December 2018
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Deep Brain Stimulation
Rechargeable Deep Brain Stimulation System
Device: Deep Brain Stimulation
Rechargeable Deep Brain Stimulation System

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).
  Eligibility

Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01221948

Locations
Austria
Wilhelminenspital and AKH
Vienna, Austria
France
CHU de Rennes-Pontchaillou
Rennes, France
Germany
University hospital, Department of Stereotaxy and functional neurosurgery
Cologne, Germany
Italy
Instituto Galeazzi IRCCS
Milano, Italy
Spain
Hospital Central de Asturias
Oviedo, Spain
United Kingdom
Frenchay Hospital
Bristol, United Kingdom
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Lars Timmermann, M.D. Uniklinik Köln, Germany
Principal Investigator: François Alesch, M.D. Allgemeines Krankenhaus AKH, Vienna, Austria
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01221948     History of Changes
Other Study ID Numbers: A5001 
Study First Received: October 8, 2010
Results First Received: July 27, 2015
Last Updated: November 23, 2015
Health Authority: Austria: Agency for Health and Food Safety
Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Italy: Ministry of Health
Spain: Spanish Agency of Medicines

Keywords provided by Boston Scientific Corporation:
Deep Brain Stimulation
Parkinson's Disease

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on July 26, 2016