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: April 19, 2013
Last verified: April 2013
  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: Allocation: Non-Randomized
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:
  • Change in the motor score of the Unified Parkinson's Disease Rating Scale (UPDRS) [ Time Frame: 26 weeks post first lead implantation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Change in the motor score of the Unified Parkinson's Disease Rating Scale (UPDRS) [ Time Frame: 12 weeks post first lead implantation ] [ Designated as safety issue: No ]
  • Change in the mentation, behavior, and mood scores of the UPDRS [ Time Frame: 12 weeks post first lead implantation ] [ Designated as safety issue: No ]
  • Change in antiparkinsonian medication use [ Time Frame: 12 weeks post first lead implantation ] [ Designated as safety issue: No ]
  • Change in hand-arm movement test score [ Time Frame: 12 weeks post first lead implantation ] [ Designated as safety issue: No ]
  • Change in tremor rating scale [ Time Frame: 12 weeks post first lead implantation ] [ Designated as safety issue: No ]
  • Change in the dyskinesia rating scale score [ Time Frame: 12 weeks post first lead implantation ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change in quality of life scale scores [ Time Frame: 12 weeks post first lead implantation ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Changes in resource utilization [ Time Frame: 12 weeks post first lead implantation ] [ Designated as safety issue: No ]
  • Change in freezing of gait episodes [ Time Frame: 12 weeks post first lead implantation ] [ Designated as safety issue: No ]
  • Change in the motor score of the Unified Parkinson's Disease Rating Scale (UPDRS) [ Time Frame: 52 weeks post first lead implantation ] [ Designated as safety issue: No ]
  • Change in the mentation, behavior, and mood scores of the UPDRS [ Time Frame: 26 weeks post first lead implantation ] [ Designated as safety issue: No ]
  • Change in the mentation, behavior, and mood scores of the UPDRS [ Time Frame: 52 weeks post first lead implantation ] [ Designated as safety issue: No ]
  • Change in the activities of daily living score of the UPDRS [ Time Frame: 12 weeks post first lead implantation ] [ Designated as safety issue: No ]
  • Change in the activities of daily living score of the UPDRS [ Time Frame: 26 weeks post first lead implantation ] [ Designated as safety issue: No ]
  • Change in the activities of daily living score of the UPDRS [ Time Frame: 52 weeks post first lead implantation ] [ Designated as safety issue: No ]
  • Change in the therapy complication score of the UPDRS [ Time Frame: 12 weeks post first lead implantation ] [ Designated as safety issue: No ]
  • Change in the therapy complication score of the UPDRS [ Time Frame: 26 weeks post first lead implantation ] [ Designated as safety issue: No ]
  • Change in the therapy complication score of the UPDRS [ Time Frame: 52 weeks post first lead implantation ] [ Designated as safety issue: No ]
  • Change in the overall score of the UPDRS [ Time Frame: 12 weeks post first lead implantation ] [ Designated as safety issue: No ]
  • Change in the overall score of the UPDRS [ Time Frame: 26 weeks post first lead implantation ] [ Designated as safety issue: No ]
  • Change in the overall score of the UPDRS [ Time Frame: 52 weeks post first lead implantation ] [ Designated as safety issue: No ]
  • Change in antiparkinsonian medication use [ Time Frame: 26 weeks post first lead implantation ] [ Designated as safety issue: No ]
  • Change in antiparkinsonian medication use [ Time Frame: 52 weeks post first lead implantation ] [ Designated as safety issue: No ]
  • Change in hand-arm movement test score [ Time Frame: 26 weeks post first lead implantation ] [ Designated as safety issue: No ]
  • Change in hand-arm movement test score [ Time Frame: 52 weeks post first lead implantation ] [ Designated as safety issue: No ]
  • Change in walking test score [ Time Frame: 12 weeks post first lead implantation ] [ Designated as safety issue: No ]
  • Change in walking test score [ Time Frame: 26 weeks post first lead implantation ] [ Designated as safety issue: No ]
  • Change in walking test score [ Time Frame: 52 weeks post first lead implantation ] [ Designated as safety issue: No ]
  • Change in tremor rating scale [ Time Frame: 26 weeks post first lead implantation ] [ Designated as safety issue: No ]
  • Change in tremor rating scale [ Time Frame: 52 weeks post first lead implantation ] [ Designated as safety issue: No ]
  • Change in the dyskinesia rating scale score [ Time Frame: 26 weeks post first lead implantation ] [ Designated as safety issue: No ]
  • Change in the dyskinesia rating scale score [ Time Frame: 52 weeks post first lead implantation ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change in quality of life scale scores [ Time Frame: 26 weeks post first lead implantation ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Change in the Global Impression of Change Scale (GIC) rating score [ Time Frame: 52 weeks post first lead implantation ] [ Designated as safety issue: No ]
  • Changes in resource utilization [ Time Frame: 26 weeks post first lead implantation ] [ Designated as safety issue: No ]
  • Changes in resource utilization [ Time Frame: 52 weeks post first lead implantation ] [ Designated as safety issue: No ]
  • Change in freezing of gait episodes [ Time Frame: 26 weeks post first lead implantation ] [ Designated as safety issue: No ]
  • Change in freezing of gait episodes [ Time Frame: 52 weeks post first lead implantation ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: October 2010
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Deep Brain Stimulation
    Rechargeable Deep Brain Stimulation System
  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
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

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01221948     History of Changes
Other Study ID Numbers: A5001
Study First Received: October 8, 2010
Last Updated: April 19, 2013
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
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders

ClinicalTrials.gov processed this record on October 23, 2014