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| Name | Class |
|---|---|
| University of Colorado, Denver | OTHER |
| Hadassah Medical Organization | OTHER |
| Swedish Medical Center | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HaGuide version 1.0 software module | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HaGuide version 1.0 software module | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| HaGuide vs. Neurosurgeon measurements | Percent agreement between HaGuide software measurements and expert Neurosurgeon/Electrophysiologist measurements | 2 weeks |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| John A Thompson, Dr. | University of Colorado, Denver | Principal Investigator |
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| 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 |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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