Impact of Subthalamic Nucleus Deep Brain Stimulation on COGnitive and PSYchiatric Symptoms in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Fluency
研究概览
简要总结
With this study, the investigators want to investigate how deep brain stimulation (DBS) affects various cognitive and psychiatric symptoms of Parkinson's disease (PD). In particular, they will examine whether stimulation of the left hemisphere has a different effect than stimulation of the right hemisphere on cognitive and psychiatric symptoms.
详细描述
Previous studies have shown that motor symptoms improve with DBS in PD. It is also know that DBS can have an effect on cognitive and psychiatric symptoms. However, in the studies completed so far, it has not yet been possible to conclusively assess the exact effect of the stimulation itself on various cognitive and psychiatric symptoms. In particular, there is currently no data on how the precise localization of stimulation at the target site-the subthalamic nucleus (STN)-affects cognitive and psychiatric symptoms. It is not yet clear whether electrical stimulation of the right subthalamic nucleus has different effects on cognition and mood than stimulation of the left subthalamic nucleus. The aim of this study is to investigate whether DBS of the left hemisphere affects cognition and mood differently than DBS of the right hemisphere.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with Parkinson's disease
- •Treated with subthalamic nucleus deep brain stimulation (STN-DBS)
- •For part I: General research consent for the analysis of routine clinical data
- •For part II of the study: ability to provide informed consent
- •native German or French speaker
- •Montreal Cognitive Assessment with score ≥ 20
排除标准
- •Atypical Parkinsonism
- •Other disease affecting the brain (e.g. Alzheimer's disease, vascular dementia, multiple sclerosis, stroke, traumatic brain injury, non-provoked epilepsy, brain tumour, etc.)
- •Haemorrhage during implantation of STN-DBS, which resulted in permanent cognitive or physical impairment
- •Schizophrenia, ongoing substance abuse, bipolar disorder or autism
- •For part II: Severe depressive disorder and/or suicidality
- •Insufficient quality or lack of brain imaging data pre and/or post STN-DBS
研究组 & 干预措施
Experimental Part II, left hemisphere first turned off
Parkinson's disease patients of Part II, in whom the left hemisphere is first turned off
干预措施: DBS OFF state for left hemisphere (Other)
Experimental Part II, right hemisphere first turned off
Parkinson's disease patients of Part II, in whom the right hemisphere is first turned off
干预措施: DBS OFF state for left hemisphere (Other)
Experimental Part II, right hemisphere first turned off
Parkinson's disease patients of Part II, in whom the right hemisphere is first turned off
干预措施: DBS OFF state for right hemisphere (Other)
Experimental Part II, left hemisphere first turned off
Parkinson's disease patients of Part II, in whom the left hemisphere is first turned off
干预措施: DBS OFF state for right hemisphere (Other)
结局指标
主要结局
Fluency
时间窗: Baseline visit
Change in composite verbal fluency score for left versus right hemispheric stimulation. To calculate the composite verbal fluency score, the standardized z-scores for phonemic and semantic verbal fluency task will be averaged. For the semantic fluency task, participants generate orally as many category names as possible during 2 minutes (German category 1: professions, category 2: hobbies; French category 1: furniture; category 2: fruit). During the phonemic fluency task, participants generate orally as many words as possible beginning with a certain letter while respecting the following rules: no repetition and no word with the same root, and no proper nouns (German: P-words, M-words; French: R-words, V-words). During each condition (right side stimulation OFF and left side stimulation OFF), one semantic fluency task and one phonemic fluency task will be performed (making sure the same letter and cateogry are only assessed once).
次要结局
- Impulsivity(Baseline visit)
- Neuropsychiatric(Baseline visit)