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Sponsor (Intelect Medical, Inc.) was acquired by Boston Scientific and study was canceled.
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The purpose of this study is to assess the cognitive performance in patients with advanced Parkinson's disease receiving Deep Brain Stimulation (DBS) with settings predetermined clinically to settings derived from a patient-specific computational model.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinical | Active Comparator | Stimulation settings predetermined clinically (Clinical) |
|
| Model | Experimental | stimulation settings derived from a patient-specific computer-based model (Model) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GUIDE software, Version 0.1 | Device | The GUIDE software uses computer-based models to determine the spread of stimulation from DBS therapy into surrounding nuclei of the brain. The software models stimulation and is not used to program or communicate with the patient's implanted DBS System. The software was recently validated in a multi-center clinical study. |
| Measure | Description | Time Frame |
|---|---|---|
| sustained improvement in working memory | The primary endpoint of this study is to determine whether or not sustained improvement in working memory can be obtained during DBS with stimulation settings derived from a patient-specific computer-based model (Model) as compared with stimulation settings predetermined clinically (Clinical). | 2 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life (QOL)improvements | The secondary endpoints will evaluate whether or not sustained cognitive improvements translate into other aspects of the patient's life (e.g. mood, activities of daily living, apathy, etc.) during DBS with stimulation settings derived from a patient-specific computer-based model (Model) as compared with stimulation settings predetermined clinically (Clinical). | 2 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 | United States | ||
| North Shore University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20061324 | Background | Frankemolle AM, Wu J, Noecker AM, Voelcker-Rehage C, Ho JC, Vitek JL, McIntyre CC, Alberts JL. Reversing cognitive-motor impairments in Parkinson's disease patients using a computational modelling approach to deep brain stimulation programming. Brain. 2010 Mar;133(Pt 3):746-61. doi: 10.1093/brain/awp315. Epub 2010 Jan 7. |
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|
| Clinically defined stimulation parameters | Device | Stimulation parameters clinically determined prior to start of clinical study |
|
| Manhasset |
| New York |
| 11030 |
| United States |
| Evergreen Healthcare | Kirkland | Washington | 98034 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| 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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