Status:
COMPLETED
Validation of HaGuide Software Module Accuracy in Mapping STN Boundaries in Parkinson's Disease Patients Who Underwent DBS Procedure
Lead Sponsor:
Alpha Omega Engineering Ltd.
Collaborating Sponsors:
University of Colorado, Denver
Hadassah Medical Organization
Conditions:
Parkinson Disease
Deep Brain Stimulation
Eligibility:
All Genders
Brief Summary
HaGuide version 1.0 (Neuro-Omega Ltd.) is a software module add-on to the FDA cleared Neuro-Omega System (K123796). It was designed to facilitate the use of Neuro-Omega's system by automatically mappi...
Eligibility Criteria
Inclusion
- Patient was diagnosed with Parkinson's disease;
- Patient underwent implantation of DBS electrode in the STN for the treatment of Parkinson's disease, using the Neuro-Omega device for navigation;
- Procedure's MER digital recorded data is available;
Exclusion
- DBS performed for any other movement disorder other than Parkinson's Disease including Parkinsonism;
- The recording has a high intensity of noise that will not allow re-analysis using the HaGuide software, in such cases the HaGuide software indicates that the signal is not valid for analysis;
- Missing data for primary end-point on the respective patient medical chart;
- The collected data that is used for the validation is with high step size resolution;
Key Trial Info
Start Date :
December 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 30 2017
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT03363724
Start Date
December 1 2016
End Date
March 30 2017
Last Update
December 6 2017
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