Clinical trial NCT01221948: Vercise Implantable Stimulator for Treating Parkinson's Disease
Official title: VANTAGE STUDY Vercise™ Implantable Stimulator for Treating Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Idiopathic Parkinson's Disease
Keywords: Deep Brain Stimulation
Parkinson's Disease
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2010-10-18
Enrollment: 53
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Boston Scientific Vercise Deep Brain Stimulation system will be implanted and each patient will serve as its own control.
Primary purpose: TREATMENT

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).

Eligibility 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.

Primary outcomes:
measure: 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).
timeFrame: 26 weeks post first lead implantation
Secondary outcomes:
measure: Mean Change in UPDRS III Score From Baseline Meds Off to 12 and 52 Weeks Post First Lead Implantation Stim on/Meds Off.
timeFrame: 12 and 52 weeks post first lead implantation
measure: Mean Change in UPDRS II Score From Baseline Meds Off to 12, 26 and 52 Weeks Post First Lead Implantation Stim on/Meds Off.
timeFrame: 12, 26 and 52 weeks post first lead implantation
measure: Mean Change in Antiparkinsonian Medication Use in Mgs (Levodopa or Equivalents) From Baseline to 12, 26 and 52 Weeks Post First Lead Implantation
timeFrame: 12, 26 and 52 weeks post first lead implantation
measure: 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.
timeFrame: 12, 26 and 52 weeks post first lead implantation
measure: 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.
timeFrame: 12, 26 and 52 weeks post first lead implantation
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
timeFrame: 12, 26 and 52 weeks post first lead implantation
measure: Percentage of Participants With Improved, No Change or Worsened Global Impression of Change (GIC) as Compared to Baseline, Evaluated by the Neurologist.
timeFrame: 52 weeks post first lead implantation
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Allgemeines Krankenhaus AKH
city: Rennes
country: France
facility: CHU de Rennes-Pontchaillou
city: Cologne
country: Germany
facility: Uniklinik Köln
city: Milano
country: Italy
facility: IRCCS Istituto Ortopedico Galeazzi
city: Oviedo
country: Spain
facility: Hospital Central de Asturias
city: Bristol
country: United Kingdom
facility: Frenchay Hospital
city: Bristol
country: United Kingdom
facility: Southmead Hospital Bristol
Study officials:
affiliation: Universitätsklinikum Köln
name: Lars Timmermann, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Allgemeines Krankenhaus AKH, Vienna, Austria
name: François Alesch, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.