Back to resultsVercise Implantable Stimulator for Treating Parkinson's Disease (VANTAGE)
Primary Purpose
Idiopathic Parkinson's Disease
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Deep Brain Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Parkinson's Disease focused on measuring Deep Brain Stimulation, Parkinson's Disease
Eligibility Criteria
Key Inclusion Criteria:
- Diagnosis of bilateral idiopathic PD with the presence of at least 2 of the following: resting tremor, rigidity, or bradykinesia.
- Duration of bilateral idiopathic PD of more than five years.
- Stable medications
- UPDRS subset III score of ≥30 without medication.
- Lack of dementia or depression.
- Must improve with antiparkinsonian medication, but have some motor complications that are not well controlled by medications.
- Must be an appropriate candidate for the surgical procedures required for bilateral STN DBS.
- Is willing and able to comply with all visits and study related procedures
- 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:
- Any intracranial abnormality or medical condition that would contraindicate DBS surgery.
- Any finding in neuropsychological screening assessments that would contraindicate DBS surgery, including dementia.
- Any significant psychiatric problems, including unrelated clinically significant depression.
- Any current drug or alcohol abuse.
- Any history of recurrent or unprovoked seizures.
- Frequent falls while receiving good medication therapy without dyskinesias (on-state).
- Any prior movement disorder treatments that involved intracranial surgery or device implantation.
- Any other active implanted device.
- Any previous brain surgery that would interfere with the placement of the leads or the functioning of the device.
- A history of neurostimulation intolerance in any area of the body.
- A condition requiring or likely to require the use of magnetic resonance imaging (MRI) or diathermy.
- Currently on any anticoagulant medications that can not be discontinued during perioperative period.
- 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.
- 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.
- A female that is breastfeeding or of child bearing potential with a positive urine pregnancy test or not using adequate contraception.
Sites / Locations
- Allgemeines Krankenhaus AKH
- CHU de Rennes-Pontchaillou
- Uniklinik Köln
- IRCCS Istituto Ortopedico Galeazzi
- Hospital Central de Asturias
- Frenchay Hospital
- Southmead Hospital Bristol
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Deep Brain Stimulation
Arm Description
Rechargeable Deep Brain Stimulation System
Outcomes
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).
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.
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.
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
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.
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.
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
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.
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.
Full Information
NCT ID
NCT01221948
First Posted
October 8, 2010
Last Updated
November 17, 2020
Sponsor
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT01221948
Brief Title
Vercise Implantable Stimulator for Treating Parkinson's Disease
Acronym
VANTAGE
Official Title
VANTAGE STUDY Vercise™ Implantable Stimulator for Treating Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
June 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Parkinson's Disease
Keywords
Deep Brain Stimulation, Parkinson's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Deep Brain Stimulation
Arm Type
Experimental
Arm Description
Rechargeable Deep Brain Stimulation System
Intervention Type
Device
Intervention Name(s)
Deep Brain Stimulation
Intervention Description
Rechargeable Deep Brain Stimulation System
Primary Outcome Measure Information:
Title
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).
Description
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.
Time Frame
26 weeks post first lead implantation
Secondary Outcome Measure Information:
Title
Mean Change in UPDRS III Score From Baseline Meds Off to 12 and 52 Weeks Post First Lead Implantation Stim on/Meds Off.
Description
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.
Time Frame
12 and 52 weeks post first lead implantation
Title
Mean Change in UPDRS II Score From Baseline Meds Off to 12, 26 and 52 Weeks Post First Lead Implantation Stim on/Meds Off.
Description
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.
Time Frame
12, 26 and 52 weeks post first lead implantation
Title
Mean Change in Antiparkinsonian Medication Use in Mgs (Levodopa or Equivalents) From Baseline to 12, 26 and 52 Weeks Post First Lead Implantation
Description
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
Time Frame
12, 26 and 52 weeks post first lead implantation
Title
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.
Description
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.
Time Frame
12, 26 and 52 weeks post first lead implantation
Title
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.
Description
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.
Time Frame
12, 26 and 52 weeks post first lead implantation
Title
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
Description
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).
Time Frame
12, 26 and 52 weeks post first lead implantation
Title
Percentage of Participants With Improved, No Change or Worsened Global Impression of Change (GIC) as Compared to Baseline, Evaluated by the Neurologist.
Description
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.
Time Frame
52 weeks post first lead implantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Diagnosis of bilateral idiopathic PD with the presence of at least 2 of the following: resting tremor, rigidity, or bradykinesia.
Duration of bilateral idiopathic PD of more than five years.
Stable medications
UPDRS subset III score of ≥30 without medication.
Lack of dementia or depression.
Must improve with antiparkinsonian medication, but have some motor complications that are not well controlled by medications.
Must be an appropriate candidate for the surgical procedures required for bilateral STN DBS.
Is willing and able to comply with all visits and study related procedures
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:
Any intracranial abnormality or medical condition that would contraindicate DBS surgery.
Any finding in neuropsychological screening assessments that would contraindicate DBS surgery, including dementia.
Any significant psychiatric problems, including unrelated clinically significant depression.
Any current drug or alcohol abuse.
Any history of recurrent or unprovoked seizures.
Frequent falls while receiving good medication therapy without dyskinesias (on-state).
Any prior movement disorder treatments that involved intracranial surgery or device implantation.
Any other active implanted device.
Any previous brain surgery that would interfere with the placement of the leads or the functioning of the device.
A history of neurostimulation intolerance in any area of the body.
A condition requiring or likely to require the use of magnetic resonance imaging (MRI) or diathermy.
Currently on any anticoagulant medications that can not be discontinued during perioperative period.
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.
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.
A female that is breastfeeding or of child bearing potential with a positive urine pregnancy test or not using adequate contraception.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Timmermann, M.D.
Organizational Affiliation
Uniklinik Köln, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
François Alesch, M.D.
Organizational Affiliation
Allgemeines Krankenhaus AKH, Vienna, Austria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allgemeines Krankenhaus AKH
City
Vienna
Country
Austria
Facility Name
CHU de Rennes-Pontchaillou
City
Rennes
Country
France
Facility Name
Uniklinik Köln
City
Cologne
Country
Germany
Facility Name
IRCCS Istituto Ortopedico Galeazzi
City
Milano
Country
Italy
Facility Name
Hospital Central de Asturias
City
Oviedo
Country
Spain
Facility Name
Frenchay Hospital
City
Bristol
Country
United Kingdom
Facility Name
Southmead Hospital Bristol
City
Bristol
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
26027940
Citation
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.
Results Reference
derived
Learn more about this trial
Vercise Implantable Stimulator for Treating Parkinson's Disease
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