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The aim of the study is to improve estimation of cognitive outcome after STN-DBS in PD in order to avoid risk factors by optimizing peri- and intraoperative management personalize therapeutic strategies for optimal long-term benefit.
The investigators will test possible predictors (clinical, neuropsychological, neuroimaging, electrophysiological and molecular) for the risk of cognitive dysfunction after deep brain stimulation of the subthalamic nucleus (STN-DBS) in Parkinson's disease (PD) at a single center (Charité - Universitätsmedizin Berlin, Germany). Data collection takes place prior to as well as 3, 12 and 60 months after the STN-DBS operation. Participation is proposed to all PD patients that are planned to undergo STN-DBS after careful examination of eligibility for this treatment according to standard operation procedures.
Additionally to clinical routine tests, the following possible predictors of cognitive dysfunction after STN-DBS in PD are investigated:
Substudies
Correlation of domain specific CANTAB connect test scores with possible predictors and incidence of postoperative neurocognitive disorder
The resulting multivariate risk model is expected
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuropsychological Testing | Diagnostic Test | Neuropsychological Testing via Cambridge CANTAB Connect |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cognitive performance after STN-DBS | Based on cognitive screening by Cambridge CANTAB Connect | Difference between baseline, 12 and 60 months postoperative testing |
| Incidence of postoperative neurocognitive disorder | Based on cognitive screening by paper pencil test (MoCA or MDRS) | Difference between baseline, 12 and 60 months postoperative testing |
| Measure | Description | Time Frame |
|---|---|---|
| Validation of post-hoc model from prior study (NCT03982953) | MoCA1yFU = 0.7 × MoCAbaseline + 1.7 × backward spanbaseline - 1, (see https://doi.org/10.1038/s41531-025-01128-3) | 1 year after DBS surgery |
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Inclusion Criteria:
Exclusion Criteria:
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PD patients that are planned to undergo STN-DBS.
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| Name | Affiliation | Role |
|---|---|---|
| Dorothee Kübler-Weller, MD | Movement Disorders and Neuromodulation | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité - Universitätsmedizin Berlin | Berlin | 13351 | Germany |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D010300 | Parkinson Disease |
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D020734 | Parkinsonian Disorders |
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| D001480 |
| Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |