Predicting Cognition After DBS for Parkinson's Disease | NCT03982953

NCT03982953

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Description Module

Detailed 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 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

Design Module

Interventional Study Design

Biospecimen

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in cognitive performance after STN-DBS	Based on cognitive screening by paper pencil test (MoCA)	Difference between pre- and 12 months postoperative testing
Incidence of postoperative neurocognitive disorder	• According to DSM-5 criteria applying the tablet-based neuropsychological test battery Cambridge Neuropsychological Test Automated Battery (CANTAB connect)	Difference between pre- and 3 and 12 months postoperative testing

Eligibility Module

Contacts/Locations Module

Name	Role	Phone	Extension	Email
Dorothee Kübler, MD	Contact	+4930450660528		dorothee.kuebler@charite.de

Name	Affiliation	Role
Andrea A Kühn, Prof. MD	Neurology, Head of the Movement Disorders and Neuromodulation Section	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Charité - Universitätsmedizin Berlin	Recruiting	Berlin		13351	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40877314	Derived	Kubler-Weller D, Stuke H, Astalosch M, Martins Ribeiro L, Landfried E, Schneider GH, Faust K, Krause P, Roediger J, Haufe S, Mousavi M, Al-Fatly B, Spies C, Borchers F, Kuhn AA. Predicting cognition after subthalamic Deep Brain Stimulation in Parkinson's Disease. NPJ Parkinsons Dis. 2025 Aug 28;11(1):265. doi: 10.1038/s41531-025-01128-3.

IPD Sharing Statement Module

Condition Browse Module

ID	Term
D010300	Parkinson Disease
D000071257	Emergence Delirium

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases