movement disorder that affects the brain and results in shaking and/or stiffness of certain body parts parkinson's disease
Conditions
Interventions
Routine implantation of Boston Scientific's Vercise* PC Deep Brain Stimulation
System with the directional lead
Sponsors
Boston Scientific Cooperation International
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: IC1. Candidate for Vercise* PC DBS with bilateral implant of BSN DBS Directional Leads in STN, and meets: • Diagnosis of bilateral idiopathic PD with the presence of rigidity and at least one (1) of the following: resting tremor or bradykinesia. • UPDRS III score of >25 in the meds OFF condition • Medication must improve PD symptoms by >=30%, as measured by UPDRS subset III score IC2. Willing and able to comply with all visits, including required travel, and with study related procedures IC3. Meets all requirements of Vercise* PC Local Directions For Use (DFU) IC4. Able to understand the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed
Exclusion criteria
Exclusion criteria: EC1. Any significant psychiatric problems, including unrelated clinically significant depression as determined by the investigator EC2. Any current drug or alcohol abuse as determined by the investigator EC3. Any history of recurrent or unprovoked seizures EC4. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Due to the exploratory nature of the study no formal primary endpoints have been defined. Collected data will be used to guide product development and to build early experience to define the best practice for programming. | — |
Secondary
| Measure | Time frame |
|---|---|
| Exploratory endpoints are: • Amplitude (mA) of stimulation induced side effect threshold during intra-operative testing. • Amplitude (mA) difference between efficacy threshold for control of rigidity and first limiting stimulation induced side effect threshold, i.e. *therapeutic window*, for all evaluated settings at Programming Visits - Day 1, 2 and 3 • UPDRS III Scores for selected settings at Programming Visits - Day 1, 2 and 3 and at Randomization, Crossover, Release, and 1 Year Follow Up Visits • Kinesia ONE scores for selected settings at Programming Visits - Day 1, 2 and 3 and at Randomization, Crossover, Release, and 1 Year Follow Up Visits • PDQ-39 Scores at Randomization, Crossover, Release, and 1 Year Follow Up Visits • Kinesia 360 motor diary scores during Crossover Arms 1 and 2 | — |
Countries
Netherlands
Outcome results
None listed