Intra-operative evaluation of efficacy and safety of a new lead for steering Deep Brain Stimulation.
Recruiting
- Conditions
- Parkinson's disease, Deep Brain StimulationZiekte van Parkinson, Diepe Hersenstimulatie
- Registration Number
- NL-OMON20700
- Lead Sponsor
- Sapiens Steering Brain Stimulation B.V.H.C.F. Martens, PhDDirector of Clinical ScienceHigh Tech Campus 485656 AE EindhovenThe NetherlandsTel: +31 40 800 2104
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
1. Diagnosis of idiopathic Parkinson's disease;
2. Clinical indication for STN DBS with MER;
Exclusion Criteria
1. Parkinson's disease graded according to Hoehn and Yahr stage 5;
2. Score on MATTIS dementia rating scale <120;
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Description of and threshold for effects obtained by stimulation through Sapiens lead in standard mode;<br /><br>2. Analysis of safety of stimulation with the Sapiens lead compared to control data.
- Secondary Outcome Measures
Name Time Method 1. Description of and threshold for effects obtained by stimulation through Sapiens lead in different modes;<br /><br>2. Determination and comparison of therapeutic window, obtained by stimulation through Sapiens lead in different modes.