Parkinson Disease
Conditions
Brief summary
The objective of this study is to evaluate the performance of novel DBS programming methods compared to traditional programming methods.
Interventions
DEVICEVercise Deep Brain Stimulation System
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Implanted bilaterally in STN or GPi with a Vercise™ DBS system for Parkinson's disease, including directional leads, for at least four months and programming optimized according to standard of care with no changes to electrode configuration of primary settings for at least four weeks. * Able to understand the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed. * Be at least 18 years of age. * Device must have been implanted on label or must be on label by the time the subject gets enrolled. Key
Exclusion criteria
* Any significant psychiatric problems, including unrelated clinically significant depression as determined by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in time to program between the two arms at Programming Visit | at least four months post implant |
Countries
Germany
Outcome results
None listed