Overview

This trial is active, not recruiting.

Condition idiopathic parkinson's disease
Treatment deep brain stimulation
Phase phase 2
Sponsor Boston Scientific Corporation
Start date October 2010
End date May 2013
Trial size 40 participants
Trial identifier NCT01221948, A5001

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Change in the motor score of the Unified Parkinson's Disease Rating Scale (UPDRS)
time frame: 26 weeks post first lead implantation

Secondary Outcomes

Measure
Number of participants with adverse events (AEs), including serious adverse events (SAEs), as a measure of Safety
time frame: 52 weeks post first lead implantation
Change in the motor score of the Unified Parkinson's Disease Rating Scale (UPDRS)
time frame: 12 weeks post first lead implantation
Change in the mentation, behavior, and mood scores of the UPDRS
time frame: 12 weeks post first lead implantation
Change in antiparkinsonian medication use
time frame: 12 weeks post first lead implantation
Change in hand-arm movement test score
time frame: 12 weeks post first lead implantation
Change in tremor rating scale
time frame: 12 weeks post first lead implantation
Change in the dyskinesia rating scale score
time frame: 12 weeks post first lead implantation
Change in the number of waking hours per day with good symptom control and no troublesome dyskinesia
time frame: 12 weeks post first lead implantation
Change in quality of life scale scores
time frame: 12 weeks post first lead implantation
Change in the Global Impression of Change Scale (GIC) rating score
time frame: 12 weeks post first lead implantation
Changes in resource utilization
time frame: 12 weeks post first lead implantation
Change in freezing of gait episodes
time frame: 12 weeks post first lead implantation
Change in the motor score of the Unified Parkinson's Disease Rating Scale (UPDRS)
time frame: 52 weeks post first lead implantation
Change in the mentation, behavior, and mood scores of the UPDRS
time frame: 26 weeks post first lead implantation
Change in the mentation, behavior, and mood scores of the UPDRS
time frame: 52 weeks post first lead implantation
Change in the activities of daily living score of the UPDRS
time frame: 12 weeks post first lead implantation
Change in the activities of daily living score of the UPDRS
time frame: 26 weeks post first lead implantation
Change in the activities of daily living score of the UPDRS
time frame: 52 weeks post first lead implantation
Change in the therapy complication score of the UPDRS
time frame: 12 weeks post first lead implantation
Change in the therapy complication score of the UPDRS
time frame: 26 weeks post first lead implantation
Change in the therapy complication score of the UPDRS
time frame: 52 weeks post first lead implantation
Change in the overall score of the UPDRS
time frame: 12 weeks post first lead implantation
Change in the overall score of the UPDRS
time frame: 26 weeks post first lead implantation
Change in the overall score of the UPDRS
time frame: 52 weeks post first lead implantation
Change in antiparkinsonian medication use
time frame: 26 weeks post first lead implantation
Change in antiparkinsonian medication use
time frame: 52 weeks post first lead implantation
Change in hand-arm movement test score
time frame: 26 weeks post first lead implantation
Change in hand-arm movement test score
time frame: 52 weeks post first lead implantation
Change in walking test score
time frame: 12 weeks post first lead implantation
Change in walking test score
time frame: 26 weeks post first lead implantation
Change in walking test score
time frame: 52 weeks post first lead implantation
Change in tremor rating scale
time frame: 26 weeks post first lead implantation
Change in tremor rating scale
time frame: 52 weeks post first lead implantation
Change in the dyskinesia rating scale score
time frame: 26 weeks post first lead implantation
Change in the dyskinesia rating scale score
time frame: 52 weeks post first lead implantation
Change in the number of waking hours per day with good symptom control and no troublesome dyskinesia
time frame: 26 weeks post first lead implantation
Change in the number of waking hours per day with good symptom control and no troublesome dyskinesia
time frame: 52 weeks post first lead implantation
Change in quality of life scale scores
time frame: 26 weeks post first lead implantation
Change in quality of life scale scores
time frame: 52 weeks post first lead implantation
Change in the Global Impression of Change Scale (GIC) rating score
time frame: 26 weeks post first lead implantation
Change in the Global Impression of Change Scale (GIC) rating score
time frame: 52 weeks post first lead implantation
Changes in resource utilization
time frame: 26 weeks post first lead implantation
Changes in resource utilization
time frame: 52 weeks post first lead implantation
Change in freezing of gait episodes
time frame: 26 weeks post first lead implantation
Change in freezing of gait episodes
time frame: 52 weeks post first lead implantation

Eligibility Criteria

Male or female participants from 21 years up to 75 years old.

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.

Additional Information

Official title VANTAGE STUDY Vercise™ Implantable Stimulator for Treating Parkinson's Disease
Principal investigator Lars Timmermann, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in April 2013.
Information provided to ClinicalTrials.gov by Boston Scientific Corporation.