Predicting Cognition After DBS for Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

Predictors of Cognitive Change After Deep Brain Stimulation in the Subthalmic Nucleus in Parkinson's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03982953
• Other study ID #: EA2/040/19
• Status: Recruiting
• Start date: June 12, 2019
• Est. completion date: August 10, 2022

Study information

• Verified date: May 2021
• Source: Charite University, Berlin, Germany
• Contact: Dorothee Kübler, MD
• Phone: +4930450660528
• Email: dorothee.kuebler[@]charite.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 10, 2022
• Est. primary completion date: June 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Deep Brain Stimulation
• Delirium
• Parkinson Disease
• Parkinson's Disease
• Postoperative Delirium
• Postoperativeneurocognitive Deficit

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cognitive performance after STN-DBS	Based on cognitive screening by paper pencil test (MoCA)	Difference between pre- and 12 months postoperative testing
Primary	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