The aim of the study is to improve estimation of cognitive outcome after STN-DBS in PD in order to
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 and 12 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.
Condition or disease |
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Parkinson's Disease Deep Brain Stimulation Postoperativeneurocognitive Deficit Postoperative Delirium |
Additionally to clinical routine tests, we will investigate the following possible predictors of cognitive dysfunction after STN-DBS in PD:
Substudies
Correlation of domain specific CANTAB connect test scores with possible predictors and incidence of postoperative neurocognitive disorder
Social Cognition: comparison of pre- and postoperative Theory of Mind (ToM) abilities measured by the Yoni-Paradigma (assesses affective and cognitive ToM)
The resulting multivariate risk model is expected
Study Type : | Observational |
Estimated Enrollment : | 60 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Predictors of Cognitive Change After Deep Brain Stimulation in the Subthalmic Nucleus in Parkinson's Disease |
Actual Study Start Date : | June 12, 2019 |
Estimated Primary Completion Date : | June 10, 2022 |
Estimated Study Completion Date : | August 10, 2022 |
Group/Cohort |
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PD patients with STN-DBS
Patients with the diagnosis of Levodopa responsive idiopathic Parkinson's Disease that are planned to undergo craniectomy with implantation of bilateral DBS electrodes in the subthalamic nucleus
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Controls - PD patients with medical treatment
Patients with the diagnosis of Levodopa responsive idiopathic Parkinson's Disease that do not undergo DBS for personal reasons or contraindications for this treatment. Age, sex and disease-severity matched with PD patients with STN-DBS.
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Cholinergic biomarkers in cerebrospinal fluid (CSF)
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
PD patients that are planned to undergo STN-DBS. Possible contraindications to DBS are tested according to clinic-intern standard operation procedures. Tests include
Inclusion Criteria:
Exclusion Criteria:
Contact: Dorothee Kübler, MD | +4930450660528 | dorothee.kuebler@charite.de |
Germany | |
Charité - Universitätsmedizin Berlin | Recruiting |
Berlin, Germany, 13351 | |
Contact: Dorothee Kübler, MD +4930450660528 dorothee.kuebler@charite.de | |
Contact: Lucia K Feldmann, MD +4930450660298 |
Study Director: | Andrea A Kühn, Prof. MD | Neurology, Head of the Movement Disorders and Neuromodulation Section |
Tracking Information | |||||
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First Submitted Date | June 9, 2019 | ||||
First Posted Date | June 12, 2019 | ||||
Last Update Posted Date | May 7, 2021 | ||||
Actual Study Start Date | June 12, 2019 | ||||
Estimated Primary Completion Date | June 10, 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures | Not Provided | ||||
Original Secondary Outcome Measures | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Predicting Cognition After DBS for Parkinson's Disease | ||||
Official Title | Predictors of Cognitive Change After Deep Brain Stimulation in the Subthalmic Nucleus in Parkinson's Disease | ||||
Brief Summary |
The aim of the study is to improve estimation of cognitive outcome after STN-DBS in PD in order to
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 and 12 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. |
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Detailed Description |
Additionally to clinical routine tests, we will investigate the following possible predictors of cognitive dysfunction after STN-DBS in PD:
Substudies Correlation of domain specific CANTAB connect test scores with possible predictors and incidence of postoperative neurocognitive disorder Social Cognition: comparison of pre- and postoperative Theory of Mind (ToM) abilities measured by the Yoni-Paradigma (assesses affective and cognitive ToM) The resulting multivariate risk model is expected
|
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Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Retention: Samples Without DNA Description:
Cholinergic biomarkers in cerebrospinal fluid (CSF)
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Sampling Method | Non-Probability Sample | ||||
Study Population |
PD patients that are planned to undergo STN-DBS. Possible contraindications to DBS are tested according to clinic-intern standard operation procedures. Tests include
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Condition |
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Intervention | Not Provided | ||||
Study Groups/Cohorts |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment |
60 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | August 10, 2022 | ||||
Estimated Primary Completion Date | June 10, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 80 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts |
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Listed Location Countries | Germany | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03982953 | ||||
Other Study ID Numbers | EA2/040/19 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Dorothee Kübler, Charite University, Berlin, Germany | ||||
Study Sponsor | Charite University, Berlin, Germany | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | Charite University, Berlin, Germany | ||||
Verification Date | May 2021 |