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OpenTrials
Active, not recruiting

NCT Number: NCT06272968

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 and 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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Cognitive Impairment Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Confusion Delirium Emergence Delirium Mental Disorders Movement Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Parkinson Disease Parkinsonian Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Synucleinopathies

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Charité - Universitätsmedizin Berlin

Berlin, 13351, Germany

About this study

Additionally to clinical routine tests, the following possible predictors of cognitive dysfunction after STN-DBS in PD are investigated:

  • 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 with CANTAB assessments performed with STN-DBS stimulation switched on and off at 12- and 60-month follow-up.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neuropsychological testing

Diagnostic Test

Neuropsychological Testing via Cambridge CANTAB Connect

Primary outcomes

  1. Change in cognitive performance after STN-DBS

    Time frame: Difference between baseline, 12 and 60 months postoperative testing

    Based on cognitive screening by Cambridge CANTAB Connect

  2. Incidence of postoperative neurocognitive disorder

    Time frame: Difference between baseline, 12 and 60 months postoperative testing

    Based on cognitive screening by paper pencil test (MoCA or MDRS)

Secondary outcomes

  1. Validation of post-hoc model from prior study (NCT03982953)

    Time frame: 1 year after DBS surgery

    MoCA1yFU = 0.7 × MoCAbaseline + 1.7 × backward spanbaseline - 1, (see https://doi.org/10.1038/s41531-025-01128-3)

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2030
First posted
Feb 22, 2024
Registry last updated
Sep 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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