Predicting Cognition After DBS for Parkinson's Disease 2
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Change in cognitive performance after STN-DBS
Study Overview
Brief 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 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.
Detailed Description
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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Relevant language barrier
Outcomes
Primary Outcomes
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
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)
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
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
- Validation of post-hoc model from prior study (NCT03982953)(1 year after DBS surgery)
Investigators
Dorothee Kübler
Principal Investigator, Senior Physician
Charite University, Berlin, Germany