Phase 2
Completed N=53
Vercise Implantable Stimulator for Treating Parkinson's Disease
Source: ClinicalTrials.gov NCT01221948 ↗Enrolled (actual)
53
Serious AEs
25.0%
Results posted
Nov 2015
Primary outcomePrimary: 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
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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). |
-23.8 | — |
| SECONDARY Mean Change in UPDRS III Score From Baseline Meds Off to 12 and 52 Weeks Post First Lead Implantation Stim on/Meds Off. |
-22.3; -23.7 | — |
| 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. |
-10.5; -11.8; -10.1 | — |
| SECONDARY Mean Change in Antiparkinsonian Medication Use in Mgs (Levodopa or Equivalents) From Baseline to 12, 26 and 52 Weeks Post First Lead Implantation |
-683.126; -740; -816 | — |
| 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. |
3.1; 3; 3.5 | — |
| 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. |
-38; -29; -34.5 | — |
| 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 |
9; 12; 12.5 | — |
| SECONDARY Percentage of Participants With Improved, No Change or Worsened Global Impression of Change (GIC) as Compared to Baseline, Evaluated by the Neurologist. |
97.4; 0; 2.6 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01221948). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.