Predicting Cognition After DBS for Parkinson's Disease 2

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cognitive Impairment
• Intervention / Treatment: Diagnostic test: Neuropsychological Testing

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
• Imaging neuronal glucose metabolism with [18F]-DG PET
• Comorbidity: according to the Charlson Comorbidity Index
• Nutritional Status: defined by the Mini Nutritional Assessment (MNA-SF)
• Functional assessment of neuronal activity by 64-channel-EEG
• 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

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.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Dorothee Kübler-Weller, MD; Phone Number: +4930450660528; Email: dorothee.kuebler@charite.de
• Study Contact Backup: Name: Melanie Astalosch, MD; Phone Number: +4930450660685; Email: melanie.astalosch@charite.de

Study Locations

• Germany
  • Berlin, Germany, 13351
    • Charité - Universitätsmedizin Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

PD patients that are planned to undergo STN-DBS.

Description

Inclusion Criteria:

• Diagnosis of idiopathic Parkinson's Disease
• Indication for STN-DBS

Exclusion Criteria:

• Internistic, surgical or psychiatric contrainidications with respect to the DBS operation or treatment for the STN-DBS group
• Dementia
• Relevant language barrier

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cognitive performance after STN-DBS	Based on cognitive screening by Cambridge CANTAB Connect	Difference between pre, 12 and 60 months postoperative testing
Incidence of postoperative neurocognitive disorder	Based on cognitive screening by paper pencil test (MoCA)	Difference between pre, 12 and 60 months postoperative testing

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Study Chair: Dorothee Kübler-Weller, MD, Movement Disorders and Neuromodulation

Study record dates

Study Major Dates

• Study Start (Estimated): February 25, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: February 16, 2024
• First Submitted That Met QC Criteria: February 16, 2024
• First Posted (Estimated): February 22, 2024

Study Record Updates

• Last Update Posted (Estimated): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Cognitive Impairment; Deep Brain Stimulation; Parkinson's disease; Postoperative Delirium
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Cognition Disorders; Parkinson Disease; Cognitive Dysfunction; Parkinsonian Disorders
• Other Study ID Numbers: EA2/252/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No