Predictors of Cognitive Change After Deep Brain Stimulation in the Subthalmic Nucleus in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Incidence of postoperative neurocognitive disorder
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of idiopathic Parkinson's Disease
- •Indication for STN-DBS
排除标准
- •Internistic, surgical or psychiatric contrainidications with respect to the DBS operation or treatment for the STN-DBS group
- •Relevant language barrier
结局指标
主要结局
Incidence of postoperative neurocognitive disorder
时间窗: Difference between pre- and 3 and 12 months postoperative testing
• According to DSM-5 criteria applying the tablet-based neuropsychological test battery Cambridge Neuropsychological Test Automated Battery (CANTAB connect)
Change in cognitive performance after STN-DBS
时间窗: Difference between pre- and 12 months postoperative testing
Based on cognitive screening by paper pencil test (MoCA)
次要结局
未报告次要终点
研究者
Dorothee Kübler
Postdoc and MD
Charite University, Berlin, Germany