SPEECH as Biomarker for Emotion, Movement and cOgnition in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Part I: Changes from baseline in best acoustic speech variables to detect changes of dopaminergic and stimulation motor effect in Parkinson's disease patients
研究概览
简要总结
With this study, the investigators want to investigate whether computerized speech analysis can be used to reliably and objectively detect motor, emotional, and cognitive fluctuations in Parkinson's disease patients.
详细描述
Parkinson's disease (PD) affects mobility (motor function), thought processes (cognition) and mood (emotion). The language is one of the most complex programs in humans. It contains information about mobility, thinking and mood at the same time. These three levels of agility, thinking and mood are subject to spontaneous fluctuations and can be influenced by external stimuli such as pictures that induce emotions. In addition, these three levels are influenced on the one hand by Parkinson's disease itself, and on the other hand by its treatment with medication or with deep brain stimulation (DBS). For this reason, the investigators would like to investigate language in Parkinson's disease patients in a very detailed computerized way for motor, cognitive and emotional elements for better management of therapies.
With this study, the investigators want to investigate whether computerized speech analysis can be used to reliably and objectively detect fluctuations in motor, mood, and thinking in Parkinson's disease patients.
Even in healthy subjects, speech changes in a situational manner, due to which the investigators will also include healthy subjects as a control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with Parkinson's Disease
- •Inclusion Criteria:
- •Written informed consent
- •Idiopathic PD according to the Movement Disorders Society Criteria;
- •Age of participants > 30 and ≤ 75 years;
- •Treatment with or without bilateral deep brain stimulation in the subthalamic nucleus;
- •Fluent in German or French
排除标准
- •Dysarthria caused in addition by a condition other than PD (e.g. stroke, myasthenia);
- •Clinical diagnosis of aphasia;
- •Brain disease other than Parkinson's disease (e.g. atypical Parkinsonism, Alzheimer's disease, vascular dementia, multiple sclerosis, stroke, traumatic brain injury, epilepsy, etc.).
- •Cognitive impairment (Montreal Cognitive Assessment (MoCa) < 24/30 points);
- •Depression with acute suicidal ideation
- •Healthy Controls
- •Inclusion Criteria:
- •Written informed consent
- •Adults from 50-70 years old;
- •Fluent in German or French
- •Exclusion Criteria:
- •Diagnosis of Parkinson's disease;
- •Cognitive impairment (Montreal Cognitive Assessment (MoCa) < 24/30 points);
- •Suffering from brain disease (e.g. atypical Parkinsonism, Alzheimer's disease, vascular dementia, multiple sclerosis, stroke, traumatic brain injury, epilepsy, etc.);
- •Clinical diagnosis of aphasia, dysarthria, and stuttering;
- •Suffering from or diagnosed with psychiatric illnesses according to DSM-V criteria
研究组 & 干预措施
Healthy Controls
All healthy volunteers
Parkinson's disease patients with DBS
All Parkinson's disease patients with bilateral deep brain stimulation (DBS) in the subthalamic nucleus
干预措施: Dopaminergic OFF drug state (Other)
Parkinson's disease patients with DBS
All Parkinson's disease patients with bilateral deep brain stimulation (DBS) in the subthalamic nucleus
干预措施: DBS OFF state (Other)
Parkinson's disease patients with DBS
All Parkinson's disease patients with bilateral deep brain stimulation (DBS) in the subthalamic nucleus
干预措施: Dopaminergic ON drug state (Other)
Parkinson's disease patients with DBS
All Parkinson's disease patients with bilateral deep brain stimulation (DBS) in the subthalamic nucleus
干预措施: DBS ON state (Other)
Parkinson's disease patients without DBS
All Parkinson's disease patients without bilateral deep brain stimulation (DBS) in the subthalamic nucleus
干预措施: Dopaminergic OFF drug state (Other)
Parkinson's disease patients without DBS
All Parkinson's disease patients without bilateral deep brain stimulation (DBS) in the subthalamic nucleus
干预措施: Dopaminergic ON drug state (Other)
结局指标
主要结局
Part I: Changes from baseline in best acoustic speech variables to detect changes of dopaminergic and stimulation motor effect in Parkinson's disease patients
时间窗: Visit 2 (< 3 months)
A speech analyser software will allow extraction of basic motor acoustic speech features. The extracted variables that better index the dopaminergic medication or stimulation motor effect assessed with Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III - motor score \[0-132 pts.\] will be used as primary outcomes in this part. Higher scores in MDS-UPDRS part III means more severe motor symptoms.
Part II: Changes from baseline in best acoustic and linguistic speech variables to detect changes of dopaminergic and stimulation neuropsychological effect in Parkinson's disease patients
时间窗: Visit 2 (< 3 months)
A speech analyser software will allow extraction of basic acoustic speech features. For the linguistic domain several natural language variables will be extracted covering domains such as linguistic sense, coherence, and emotionality. The extracted variables that better index the dopaminergic medication or stimulation emotional effect assessed with Neuropsychiatric fluctuations scale (NFS) \[0-60 pts.\] will be used as primary outcomes in this part. Higher scores in NFS means more severe neuropsychiatric fluctuations.
Part III: Changes from baseline in best acoustic and linguistic speech variables to detect changes of dopaminergic and stimulation cognitive effect in Parkinson's disease patients
时间窗: Visit 2 (< 3 months)
A speech analyser software will allow extraction of basic acoustic speech features. For the linguistic domain several natural language variables will be extracted covering domains such as linguistic sense, coherence, and emotionality. The extracted variables that better index the dopaminergic medication or stimulation cognitive effect assessed with verbal fluency task will be used as primary outcomes in this part. Higher scores in Fluency task means better outcome.
次要结局
- Dyskinesia severity(At visit 1 (baseline) and visit 2 (< 3 months))
- Momentary mood state(At visit 1 (baseline) and visit 2 (< 3 months))
- Momentary anxiety state(At visit 1 (baseline) and visit 2 (< 3 months))
- Bradyphrenia assessment(At visit 1 (baseline) and visit 2 (< 3 months))