Randomized trial comparing steered stimulation DBS with ring-shaped DBS for advanced Parkinson’s disease
Recruiting
- Conditions
- Parkinson's Disease<br />Deep Brain Stimulation<br />Subthalamic Nucleus (STN)<br />Steering<br /><br />Ziekte van Parkinson<br />Diepe Hersenstimulatie<br />Nucleus Subthalamicus<br />
- Registration Number
- NL-OMON22973
- Lead Sponsor
- Academic Medical Center Amsterdam (AMC)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 102
Inclusion Criteria
Age ≥ 18 years
bilaterally implanted with the Boston Scientific® Vercise™ system in the STN for idiopathic Parkinson’s Disease at least 6 months previous to study enrollment
Exclusion Criteria
no adequate stimulation response in ring-mode on one of the steerable levels (second and third contact point on each lead)
Legally incompetent adults
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method We will evaluate the difference of motor symptoms in patients with steered and ring-mode DBS in standardized OFF-drug phase measured with the Movement Disorders Society Unified Parkinson Disease Rating Scale motor evaluation (MDS-UPDRS-ME).
- Secondary Outcome Measures
Name Time Method Secondary outcome consists of symptom scales, used stimulation settings, medication use, stimulation-induced side-effects, activities of daily living scales and a quality of life questionnaire. At the end of the trial, patients will be asked to choose between the two used programs to evaluate which one was perceived as the best. A sub-analysis will be performed to evaluate whether good DBS responders and suboptimal DBS responders score differently on primary and secondary endpoints.