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| Name | Class |
|---|---|
| Wake Forest University Health Sciences | OTHER |
| Ohio State University | OTHER |
| Wake Forest University | OTHER |
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Participants will undergo DBS programming guided by the DBS-Expert system and by a clinician per standard care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DBS-Expert Programming First | Experimental | These patients will be undergo algorithm based programming using Kinesia-based assessment (DBS-Expert) first and then be programmed by a clinician within five days. |
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| Traditional Programming First | Experimental | These patients will be programmed by a clinician first and then undergo algorithm based programming using Kinesia-based assessment (DBS-Expert) within five days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Algorithm based programming using Kinesia-based assessment | Device | DBS-Expert includes a tablet-based software application (app) for guiding DBS programming and a Kinesia motion sensor unit for automated motor assessment. Algorithms search the programming parameter space to resolve an optimal set of programming parameters. |
| Measure | Description | Time Frame |
|---|---|---|
| Programming time when programmed using Kinesia-based assessment (DBS-Expert) compared to programming time when programmed by a clinician | Amount of time it took to arrive at DBS settings that provide sufficient therapeutic benefit will be compared across programming sessions | Up to 2 hours (from start of programming session until end of programming session) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dustin A Heldman, PhD | Contact | 2163615410 | dheldman@glneurotech.com |
| Name | Affiliation | Role |
|---|---|---|
| Dustin A Heldman, PhD | Great Lakes NeuroTechnologies Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atrium Health | Recruiting | Charlotte | North Carolina | 28207 | United States |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Wake Forest University | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
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| Ohio State University | Recruiting | Columbus | Ohio | 43210 | United States |
|
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |