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).
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
53
Rechargeable Deep Brain Stimulation System
Allgemeines Krankenhaus AKH
Vienna, Austria
CHU de Rennes-Pontchaillou
Rennes, France
Uniklinik Köln
Cologne, Germany
IRCCS Istituto Ortopedico Galeazzi
Milan, Italy
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
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
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
Mean Change in Antiparkinsonian Medication Use in Mgs (Levodopa or Equivalents) From Baseline to 12, 26 and 52 Weeks Post First Lead Implantation
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Hospital Central de Asturias
Oviedo, Spain
Frenchay Hospital
Bristol, United Kingdom
Southmead Hospital Bristol
Bristol, United Kingdom
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
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
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
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
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