Objective Assessment of Behavioural Disorders in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Performance in an effort-based decision making task (Apple Tree Paradigm)
研究概览
简要总结
The aim of this project is to measure behavioural disorders in Parkinson's disease (PD) patients in a more objective way, in order to facilitate the detection of those symptoms and improve the treatment of non-motor symptoms in Parkinson's disease.
详细描述
Apathy and impulse control disorders (ICDs) are frequent non-motor symptoms of PD and negatively affect the quality of life of patients. Although healthcare professionals have begun to understand the extent of the problem faced by those suffering apathy or ICDs, accurate diagnosis is still difficult, as behavioural symptoms are often multidimensional, develop gradually over the course of months and clinical staff have to rely on the self-report of the patient or the report of a family member to assess them. To overcome this issue, the investigators aim to use information and communication technologies to measure apathy and hyperdopaminergic behaviours in PD patients with STN-DBS in an objective way, with the ultimate goal of improving the management of PD patients with STN-DBS.
To do so, the investigators will use three computer-based tasks that measure effort-based decision making and emotion processing in PD patients, and assess motor, cognitive and neuropsychiatric symptoms in parallel with scales and tests. In some select patients, motor symptoms and activity patterns will be monitored with an in-home sensor system before and after deep brain stimulation STN-DBS, and the above mentioned procedures will be repeated 4 months after STN-DBS.
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 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.
- •(Planned) STN-DBS.
- •Able to understand instructions and provide informed consent.
- •Native speaking or proficient French or German
- •Montreal Cognitive Assessment (MoCA) with score ≥ 22
- •Ability to manipulate handheld dynamometers
排除标准
- •Disease affecting the brain other than Parkinson's disease
- •Suffering from or diagnosed with ongoing psychiatric illnesses
- •Severe somatic illnesses leading to reduced life expectancy
- •Severe physical disability leading to impairment in basic functional activities
- •Participation in a pharmacological study
- •Inability to provide informed consent (legal guardianship)
结局指标
主要结局
Performance in an effort-based decision making task (Apple Tree Paradigm)
时间窗: Visit 2 (only for DBS patients; 4-6 months after DBS-surgery)
Decision (yes/no)
Performance in an emotion processing task
时间窗: Visit 2 (only for DBS patients; 4-6 months after DBS-surgery)
Pupil diameter (in mm)
Change in overall activity from Baseline to 4 months after DBS-surgery
时间窗: In-home sensor measurements will be collected from 1-3 months before DBS-surgery and 4 months after DBS-surgery
Changes in overall activity patterns related to motivated behaviours (measured in minutes per day) will be deducted from collected from in-home sensor data using signal processing and machine learning algorithms
次要结局
未报告次要终点
