Directional Lead: Investigation of Rotational Current Steering, Ease of Use of Clinical Effects Map, and Therapeutic Outcomes of Deep Brain Stimulatio
- Conditions
- movement disorder that affects the brain and results in shaking and/or stiffness of certain body partsparkinson's disease10028037
- Registration Number
- NL-OMON46916
- Lead Sponsor
- Boston Scientific Cooperation International
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 4
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
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 <12 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Due to the exploratory nature of the study no formal primary endpoints have<br /><br>been defined. Collected data will be used to guide product development and to<br /><br>build early experience to define the best practice for programming.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Exploratory endpoints are:<br /><br>• Amplitude (mA) of stimulation induced side effect threshold during<br /><br>intra-operative testing.<br /><br>• Amplitude (mA) difference between efficacy threshold for control of rigidity<br /><br>and first limiting stimulation induced side effect threshold, i.e. *therapeutic<br /><br>window*, for all evaluated settings at Programming Visits - Day 1, 2 and 3<br /><br>• UPDRS III Scores for selected settings at Programming Visits - Day 1, 2 and 3<br /><br>and at Randomization, Crossover, Release, and 1 Year Follow Up Visits<br /><br>• Kinesia ONE scores for selected settings at Programming Visits - Day 1, 2 and<br /><br>3 and at Randomization, Crossover, Release, and 1 Year Follow Up Visits<br /><br>• PDQ-39 Scores at Randomization, Crossover, Release, and 1 Year Follow Up<br /><br>Visits<br /><br>• Kinesia 360 motor diary scores during Crossover Arms 1 and 2 </p><br>