Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Deep Brain Stimulation
  • Parkinson's Disease
  • Postoperative Delirium
  • Postoperativeneurocognitive Deficit
Type
Observational
Design
Observational Model: CohortTime Perspective: Prospective

Participation Requirements

Age
Between 18 years and 80 years
Gender
Both males and females

Description

Additionally to clinical routine tests, we will investigate the following possible predictors of cognitive dysfunction after STN-DBS in PD: Imaging biomarkers: volume of the nucleus basalis of Meynert (NBM) measured on preoperative MRI and data driven search for unknown MRI characteristics relating ...

Additionally to clinical routine tests, we will investigate the following possible predictors of cognitive dysfunction after STN-DBS in PD: Imaging biomarkers: volume of the nucleus basalis of Meynert (NBM) measured on preoperative MRI and data driven search for unknown MRI characteristics relating to the incidence of postoperative neurocognitive disorder by means of Deep Learning (Convolutional Neural Networks), test of previously established classification models Molecular biomarkers in CSF: TAU, phospho-TAU, ß-Amyloid 1-40 and 1-42 as well as NFL measured preoperatively Comorbidity: according to the Charlson Comorbidity Index Nutritional Status: defined by the Mini Nutritional Assessment (MNA-SF) Duration of intra-/perioperative brake of dopaminergic medication Nature and depth of anaesthesia: general or conscious sedation and depth of consciousness: as measured by 4 channel electroencephalography (SedLine®) and during implantation of impulse generator Incidence and duration of postoperative delirium: defined according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and/or as ? 2 points in the nursing Delirium Screening Scale (Nu-DESC) and/or a positive Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) score, assessment three times daily during hospital stay Length of stay at ICU / hospital Postoperative organ complications: according to Clavien-Dindo classification Localisation of bilateral electrodes and active contacts on postoperative imaging 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 to improve peri- and intraoperative management by identifying avoidable risk factors for the development of postoperative cognitive deficit to support evidence-based and personalized decision-making when advising PD patients considering STN-DBS to result in the development of future hypothesis-driven interventional trials on the basis of biomarker-based sub-grouping of patients to allow a better understanding of underlying pathophysiological processes both PD and surgery-related regarding cognitive effects of STN-DBS

Tracking Information

NCT #
NCT03982953
Collaborators
Not Provided
Investigators
Study Director: Andrea A Kühn, Prof. MD Neurology, Head of the Movement Disorders and Neuromodulation Section