Validation of HaGuide Software Module Accuracy in Mapping STN Boundaries in Parkinson's Disease Patients Who Underwent DBS Procedure

Study Overview
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Brief Summary
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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 mapping visually the depth of STN landmarks intra-operatively. HaGuide algorithm computes and displays the STN entry and exit, as well as introduces a detection of a distinct DLOR-VMNR boundary. HaGuide visual display is added to the UI and it is supplementing and not replacing the previously cleared standard display (visual and audio) of the system.

Official Title
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A Retrospective, Multi-Center, Clinical Validation of HaGuide Software Module Accuracy in Mapping Sub-thalamic Nucleus (STN) Boundaries in Parkinson's Disease Patients Who Underwent Deep Brain Stimulation (DBS) Procedure

Conditions
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Parkinson Disease, Deep Brain Stimulation

Intervention / Treatment
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* Other: HaGuide version 1.0 software module


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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;
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HaGuide version 1.0 software module<br>Patients diagnosed with Parkinson's Disease who underwent implantation of DBS electrode in the STN for the treatment of Parkinson's Disease, using the Neuro-Omega device for navigation and procedure's MER digital recorded data is available. | Other: HaGuide version 1.0 software module<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HaGuide vs. Neurosurgeon measurements | Percent agreement between HaGuide software measurements and expert Neurosurgeon/Electrophysiologist measurements | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DLOR vs. VMNR | Length (mm) of Dorso-Lateral Oscillatory Region (DLOR) vs. Ventro-Medial Non-Oscillatory Region (VMNR); | 2 weeks | 
| DLOR Entry/exit | Entry/exit from DLOR (depth in mm) | 2 weeks | 
| STN Length | Length of STN track (mm | 2 weeks | 
| DBS implant optimal track Identification | Percent agreement in DBS implant optimal track Identification by percent agreement between HaGuide and Neurosurgeon choice of optimal track for DBS implant | 2 weeks | 
| Sites/Users comparison | Sub-group analysis to determine the variation between sites by percent agreement between HaGuide software measurements and expert Neurosurgeon/Electrophysiologist measurements | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson Disease, Deep Brain Stimulation, Microelectrodes recording, HaGuide, Alpha Omega Engineering Ltd.