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The study will explore the viability of an alternative/novel programming strategy in Deep Brain Stimulation (DBS) for patients with Parkinson's Disease (PD).
The study will explore the feasibility of utilizing an alternative/novel programming technique in Deep Brain Stimulation (DBS) for patients with Parkinson's Disease (PD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Novel Deep Brain Stimulation (nDBS) program | Experimental | This arm will include patients receiving stimulation with a novel Deep Brain Stimulation (nDBS) for Parkinson's Disease (PD). |
|
| Conventional Deep Brain Stimulation (cDBS) program | Active Comparator | This arm will include patients receiving stimulation with a conventional Deep Brain Stimulation (cDBS) for Parkinson's Disease (PD). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novel Programming (nDBS) | Device | The commercial CP installed with the investigational DBS programming software will be used to set up Novel Programming (nDBS) therapy on the IPG. |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Quality of Life using new programming paradigm: PDQ-39 | Change in Parkinson's Disease Questionnaire (PDQ-39) summary index and sub-scores | approximately 4 weeks |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Natalie Bloom Lyons | Boston Scientific Neuromodulation Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Berlin, Charite Virchow | Berlin | Germany | ||||
| Universitaetsklinikum Wuerzburg |
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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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During follow-up, the conventional Deep Brain Stimulation (cDBS) program and one or more of these novel Deep Brain Stimulation (nDBS) programs are programmed into a subject's IPG. At the investigator's discretion, a copy of the cDBS program may also be stored in one of the investigational slots. The subject will be blinded to the slot number assignment for the cDBS program.
| Conventional Programming (cDBS) | Device | The commercial CP installed with commercial software will be used to set up standard cDBS therapy on the IPG. |
|
| Würzburg |
| Germany |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |