Idiopathic Parkinson's Disease
Conditions
Keywords
Deep Brain Stimulation, 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).
Interventions
DEVICEDeep Brain Stimulation
Rechargeable Deep Brain Stimulation System
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Boston Scientific Vercise Deep Brain Stimulation system will be implanted and each patient will serve as its own control.
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in UPDRS II Score From Baseline Meds Off to 12, 26 and 52 Weeks Post First Lead Implantation Stim on/Meds Off. | 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 | 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. | 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 Change in UPDRS III Score From Baseline Meds Off to 12 and 52 Weeks Post First Lead Implantation Stim on/Meds Off. | 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 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 | 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. | 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. |
| 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. | 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. |
Countries
Austria, France, Germany, Italy, Spain, United Kingdom
Participant flow
Recruitment details
Subjects recruited at 6 European centers for the study
Participants by arm
| Arm | Count |
|---|---|
| Deep Brain Stimulation Vercise (TM) Rechargeable Deep Brain Stimulation System
Deep Brain Stimulation: Rechargeable Deep Brain Stimulation System | 40 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | not disclosed | 2 |
| Overall Study | Physician Decision | 5 |
| Overall Study | Protocol Violation | 4 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Deep Brain Stimulation |
|---|---|
| Age, Customized <=60 years | 19 participants |
| Age, Customized 61-70 years | 18 participants |
| Age, Customized >70 years | 3 participants |
| Region of Enrollment Austria | 12 participants |
| Region of Enrollment France | 1 participants |
| Region of Enrollment Germany | 9 participants |
| Region of Enrollment Italy | 1 participants |
| Region of Enrollment Spain | 11 participants |
| Region of Enrollment United Kingdom | 6 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 37 / 40 |
| serious Total, serious adverse events | 10 / 40 |
Outcome results
Primary
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.
Time frame: 26 weeks post first lead implantation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Deep Brain Stimulation | 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). | -23.8 units on a scale | Standard Deviation 10.59 |
Secondary
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
Time frame: 12, 26 and 52 weeks post first lead implantation
Population: 40 completed Baseline, 35 completed Week12, 39 completed Week 26 and 38 completed Week 52
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Deep Brain Stimulation | Mean Change in Antiparkinsonian Medication Use in Mgs (Levodopa or Equivalents) From Baseline to 12, 26 and 52 Weeks Post First Lead Implantation | Change from Baseline to 12 weeks | -683.126 mg | Standard Deviation 537.91 |
| Deep Brain Stimulation | Mean Change in Antiparkinsonian Medication Use in Mgs (Levodopa or Equivalents) From Baseline to 12, 26 and 52 Weeks Post First Lead Implantation | Change from Baseline to 26 Weeks | -740 mg | Standard Deviation 603.6 |
| Deep Brain Stimulation | Mean Change in Antiparkinsonian Medication Use in Mgs (Levodopa or Equivalents) From Baseline to 12, 26 and 52 Weeks Post First Lead Implantation | Change from Baseline to 52 weeks | -816 mg | Standard Deviation 571.4 |
Secondary
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.
Time frame: 12, 26 and 52 weeks post first lead implantation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Deep Brain Stimulation | 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. | Change from Baseline to 12 weeks in ON time | 3.1 hours/day | Standard Deviation 7.3 |
| Deep Brain Stimulation | 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. | Change from Baseline to 26 weeks in ON time | 3 hours/day | Standard Deviation 6.31 |
| Deep Brain Stimulation | 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. | Change from Baseline to 52 weeks in ON time | 3.5 hours/day | Standard Deviation 6.58 |
Secondary
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.
Time frame: 12 and 52 weeks post first lead implantation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Deep Brain Stimulation | Mean Change in UPDRS III Score From Baseline Meds Off to 12 and 52 Weeks Post First Lead Implantation Stim on/Meds Off. | Mean Change from Baseline to Week 12 | -22.3 units on a scale | Standard Deviation 8.05 |
| Deep Brain Stimulation | Mean Change in UPDRS III Score From Baseline Meds Off to 12 and 52 Weeks Post First Lead Implantation Stim on/Meds Off. | Mean Change from Baseline to Week 52 | -23.7 units on a scale | Standard Deviation 8.83 |
Secondary
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.
Time frame: 12, 26 and 52 weeks post first lead implantation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Deep Brain Stimulation | Mean Change in UPDRS II Score From Baseline Meds Off to 12, 26 and 52 Weeks Post First Lead Implantation Stim on/Meds Off. | Change from Baseline to 26 weeks | -11.8 units on a scale | Standard Deviation 5.96 |
| Deep Brain Stimulation | Mean Change in UPDRS II Score From Baseline Meds Off to 12, 26 and 52 Weeks Post First Lead Implantation Stim on/Meds Off. | Change from Baseline to 52 weeks | -10.1 units on a scale | Standard Deviation 8.55 |
| Deep Brain Stimulation | Mean Change in UPDRS II Score From Baseline Meds Off to 12, 26 and 52 Weeks Post First Lead Implantation Stim on/Meds Off. | Change from Baseline to 12 weeks | -10.5 units on a scale | Standard Deviation 7.76 |
Secondary
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).
Time frame: 12, 26 and 52 weeks post first lead implantation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Deep Brain Stimulation | 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 | Percent Change from baseline to 12 weeks | 9 percentage change | Standard Deviation 21 |
| Deep Brain Stimulation | 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 | Percent Change from baseline to 26 weeks | 12 percentage change | Standard Deviation 26.2 |
| Deep Brain Stimulation | 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 | Percent Change from Baseline to 52 weeks | 12.5 percentage change | Standard Deviation 23.4 |
Secondary
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.
Time frame: 12, 26 and 52 weeks post first lead implantation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Deep Brain Stimulation | 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. | Percent Change from Baseline to 12 Weeks | -38 percentage change | Standard Deviation 41.2 |
| Deep Brain Stimulation | 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. | Percent Change from Baseline to 26 Weeks | -29 percentage change | Standard Deviation 39 |
| Deep Brain Stimulation | 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. | Percent Change from Baseline to 52 Weeks | -34.5 percentage change | Standard Deviation 45.6 |
Secondary
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.
Time frame: 52 weeks post first lead implantation
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Deep Brain Stimulation | Percentage of Participants With Improved, No Change or Worsened Global Impression of Change (GIC) as Compared to Baseline, Evaluated by the Neurologist. | Percent Improved at 52 weeks | 97.4 percentage of participants |
| Deep Brain Stimulation | Percentage of Participants With Improved, No Change or Worsened Global Impression of Change (GIC) as Compared to Baseline, Evaluated by the Neurologist. | Percent with no change at 52 weeks | 0 percentage of participants |
| Deep Brain Stimulation | Percentage of Participants With Improved, No Change or Worsened Global Impression of Change (GIC) as Compared to Baseline, Evaluated by the Neurologist. | Percent worsened at 52 weeks | 2.6 percentage of participants |