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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01221948
Recruitment Status : Completed
First Posted : October 18, 2010
Results First Posted : November 13, 2015
Last Update Posted : November 19, 2020
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Idiopathic Parkinson's Disease
Intervention Device: Deep Brain Stimulation
Enrollment 53
Recruitment Details Subjects recruited at 6 European centers for the study
Pre-assignment Details  
Arm/Group Title Deep Brain Stimulation
Hide Arm/Group Description All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
Period Title: Overall Study
Started 53
Completed 39
Not Completed 14
Reason Not Completed
Physician Decision             5
Withdrawal by Subject             2
not disclosed             2
Death             1
Protocol Violation             4
Arm/Group Title Deep Brain Stimulation
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Vercise (TM) Rechargeable Deep Brain Stimulation System

Deep Brain Stimulation: Rechargeable Deep Brain Stimulation System

Overall Number of Baseline Participants 40
Hide Baseline Analysis Population Description
40 enrolled subjects who met study eligibility were implanted with the Vercise DBS system.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 40 participants
<=60 years 19
61-70 years 18
>70 years 3
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Female
13
  32.5%
Male
27
  67.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 40 participants
France 1
Spain 11
Austria 12
Germany 9
United Kingdom 6
Italy 1
1.Primary Outcome
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).
Hide 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
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Deep Brain Stimulation
Hide Arm/Group Description:
All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
Overall Number of Participants Analyzed 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
-23.8  (10.59)
2.Secondary Outcome
Title Mean Change in UPDRS III Score From Baseline Meds Off to 12 and 52 Weeks Post First Lead Implantation Stim on/Meds Off.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Deep Brain Stimulation
Hide Arm/Group Description:
All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
Overall Number of Participants Analyzed 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
Mean Change from Baseline to Week 12 -22.3  (8.05)
Mean Change from Baseline to Week 52 -23.7  (8.83)
3.Secondary Outcome
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.
Hide 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
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Deep Brain Stimulation
Hide Arm/Group Description:
All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
Overall Number of Participants Analyzed 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change from Baseline to 12 weeks -10.5  (7.76)
Change from Baseline to 26 weeks -11.8  (5.96)
Change from Baseline to 52 weeks -10.1  (8.55)
4.Secondary Outcome
Title Mean Change in Antiparkinsonian Medication Use in Mgs (Levodopa or Equivalents) From Baseline to 12, 26 and 52 Weeks Post First Lead Implantation
Hide 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
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Hide Analysis Population Description
40 completed Baseline, 35 completed Week12, 39 completed Week 26 and 38 completed Week 52
Arm/Group Title Deep Brain Stimulation
Hide Arm/Group Description:
All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
Overall Number of Participants Analyzed 40
Mean (Standard Deviation)
Unit of Measure: mg
Change from Baseline to 12 weeks -683.126  (537.91)
Change from Baseline to 26 Weeks -740  (603.6)
Change from Baseline to 52 weeks -816  (571.4)
5.Secondary Outcome
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.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Deep Brain Stimulation
Hide Arm/Group Description:
All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
Overall Number of Participants Analyzed 40
Mean (Standard Deviation)
Unit of Measure: hours/day
Change from Baseline to 12 weeks in ON time 3.1  (7.3)
Change from Baseline to 26 weeks in ON time 3  (6.31)
Change from Baseline to 52 weeks in ON time 3.5  (6.58)
6.Secondary Outcome
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.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Deep Brain Stimulation
Hide Arm/Group Description:
All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
Overall Number of Participants Analyzed 40
Mean (Standard Deviation)
Unit of Measure: percentage change
Percent Change from Baseline to 12 Weeks -38  (41.2)
Percent Change from Baseline to 26 Weeks -29  (39)
Percent Change from Baseline to 52 Weeks -34.5  (45.6)
7.Secondary Outcome
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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Deep Brain Stimulation
Hide Arm/Group Description:
All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
Overall Number of Participants Analyzed 40
Mean (Standard Deviation)
Unit of Measure: percentage change
Percent Change from baseline to 12 weeks 9  (21)
Percent Change from baseline to 26 weeks 12  (26.2)
Percent Change from Baseline to 52 weeks 12.5  (23.4)
8.Secondary Outcome
Title Percentage of Participants With Improved, No Change or Worsened Global Impression of Change (GIC) as Compared to Baseline, Evaluated by the Neurologist.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Deep Brain Stimulation
Hide Arm/Group Description:
All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: percentage of participants
Percent Improved at 52 weeks 97.4
Percent with no change at 52 weeks 0
Percent worsened at 52 weeks 2.6
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Deep Brain Stimulation
Hide Arm/Group Description All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
All-Cause Mortality
Deep Brain Stimulation
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Deep Brain Stimulation
Affected / at Risk (%) # Events
Total   10/40 (25.00%)    
Infections and infestations   
Influenza   2/40 (5.00%)  2
Cystitis  1/40 (2.50%)  1
Helicobacter gastritis  1/40 (2.50%)  1
Implant site infection  1/40 (2.50%)  1
Localised infection  1/40 (2.50%)  1
Pneumonia  1/40 (2.50%)  1
Staphylococcal infection  1/40 (2.50%)  1
Injury, poisoning and procedural complications   
Device migration  1/40 (2.50%)  1
Fall  1/40 (2.50%)  1
Joint sprain  1/40 (2.50%)  1
Skin laceration  1/40 (2.50%)  1
Musculoskeletal and connective tissue disorders   
Back pain  1/40 (2.50%)  2
Nervous system disorders   
Akinesia  1/40 (2.50%)  1
Parkinson's disease  1/40 (2.50%)  1
Syncope  1/40 (2.50%)  1
Respiratory, thoracic and mediastinal disorders   
Respiratory depression  1/40 (2.50%)  1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Deep Brain Stimulation
Affected / at Risk (%) # Events
Total   37/40 (92.50%)    
Cardiac disorders   
Pericardial effusion  1/40 (2.50%)  1
Eye disorders   
Diplopia  1/40 (2.50%)  1
Macular degeneration  1/40 (2.50%)  1
Gastrointestinal disorders   
Dyspepsia  2/40 (5.00%)  2
General disorders   
Gait disturbance  2/40 (5.00%)  2
Adverse drug reaction  1/40 (2.50%)  1
Axillary pain  1/40 (2.50%)  1
Cyst  1/40 (2.50%)  1
Drug withdrawal syndrome  1/40 (2.50%)  1
Implant site haematoma  1/40 (2.50%)  1
Oedema peripheral  1/40 (2.50%)  1
Pyrexia  1/40 (2.50%)  1
Infections and infestations   
Bronchitis  1/40 (2.50%)  1
Ear infection  1/40 (2.50%)  2
Incision site infection  1/40 (2.50%)  1
Postoperative wound infection  1/40 (2.50%)  1
Injury, poisoning and procedural complications   
Fall   9/40 (22.50%)  10
Hand fracture  3/40 (7.50%)  3
Head injury  2/40 (5.00%)  2
Joint sprain  1/40 (2.50%)  1
Skeletal injury  2/40 (5.00%)  2
Alcohol poisoning  1/40 (2.50%)  1
Contusion  1/40 (2.50%)  1
Fibula fracture  1/40 (2.50%)  1
Rib fracture  1/40 (2.50%)  1
Thermal burn  1/40 (2.50%)  1
Investigations   
Laboratory test abnormal  1/40 (2.50%)  1
Weight increased  1/40 (2.50%)  1
Metabolism and nutrition disorders   
Diabetes mellitus  1/40 (2.50%)  1
Fluid retention  1/40 (2.50%)  1
Folate deficiency  1/40 (2.50%)  1
Musculoskeletal and connective tissue disorders   
Back pain  2/40 (5.00%)  2
Arthralgia  1/40 (2.50%)  1
Bursitis  1/40 (2.50%)  1
Intervertebral disc protrusion  1/40 (2.50%)  1
Monarthritis  1/40 (2.50%)  1
Neck pain  1/40 (2.50%)  1
Osteoarthritis  1/40 (2.50%)  1
Pain in extremity  1/40 (2.50%)  1
Spinal osteoarthritis  1/40 (2.50%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Seborrhoeic keratosis  1/40 (2.50%)  1
Nervous system disorders   
Restless legs syndrome  3/40 (7.50%)  3
Dystonia  2/40 (5.00%)  3
Paraesthesia  2/40 (5.00%)  2
Parkinson's disease  1/40 (2.50%)  1
Speech disorder  2/40 (5.00%)  2
Syncope  1/40 (2.50%)  1
Tremor  2/40 (5.00%)  2
Cerebral microangiopathy  1/40 (2.50%)  1
Dysarthria  1/40 (2.50%)  1
Hypoaesthesia  1/40 (2.50%)  1
Memory impairment  1/40 (2.50%)  1
Movement disorder  1/40 (2.50%)  1
Nerve root lesion  1/40 (2.50%)  1
Sciatica  1/40 (2.50%)  1
Psychiatric disorders   
Depression  6/40 (15.00%)  6
Apathy  3/40 (7.50%)  3
Anger  1/40 (2.50%)  1
Anxiety  1/40 (2.50%)  1
Confusional state  1/40 (2.50%)  1
Depressed mood  1/40 (2.50%)  1
Hallucination, auditory  1/40 (2.50%)  1
Impulse-control disorder  1/40 (2.50%)  1
Insomnia  1/40 (2.50%)  1
Panic attack  1/40 (2.50%)  1
Rapid eye movements sleep abnormal  1/40 (2.50%)  1
Renal and urinary disorders   
Urinary incontinence  1/40 (2.50%)  1
Reproductive system and breast disorders   
Urinary tract infection  2/40 (5.00%)  2
Respiratory, thoracic and mediastinal disorders   
Cough  1/40 (2.50%)  1
Pleural effusion  1/40 (2.50%)  1
Productive cough  1/40 (2.50%)  1
Skin and subcutaneous tissue disorders   
Ingrowing nail  1/40 (2.50%)  1
Vascular disorders   
Hypertension  1/40 (2.50%)  1
Hypotension  1/40 (2.50%)  1
Thrombophlebitis  1/40 (2.50%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Nic Van Dyck, Director International Clinical Operations
Organization: Bostons Scientific Neuromodulation
Phone: +31 43 3568328
EMail: vandyckn@bsci.com
Layout table for additonal information
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01221948    
Other Study ID Numbers: A5001
First Submitted: October 8, 2010
First Posted: October 18, 2010
Results First Submitted: July 27, 2015
Results First Posted: November 13, 2015
Last Update Posted: November 19, 2020