Evaluation of the Cognitive Stimulation Treatment in Patients With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Efficacy of the cognitive training on cognitive function in PD patients with GBA mutation compared to a control group of PD patients without genetic mutations.
研究概览
简要总结
The goal of this observational study is to evaluate the relationship between GBA mutation and cognitive stimulation treatment response in patients with Parkinson's disease. The main questions it aim to answer are: • assess whether the GBA mutation is associated with greater or lesser response to cognitive training treatment compared to a control group of PD patients without genetic mutations. • investigate the effect of cognitive stimulation program on behavioural aspects as secondary consequence induced by the possible improvement of cognitive abilities following treatment.
Participants will be undergo to: - a neuropsychological evaluation describing their cognitive profile; - a genetic investigation and finally included in a cognitive stimulation programs according to regular clinical practice. Researchers will compare PD patients with GBA mutation and patients without genetic mutation to evaluate the effectiveness of cognitive stimulation treatment.
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
- •Patients with Parkinson's disease according to the Gelb et al. criteria;
- •Patients who have carried out genetic screening for MP;
- •Patients who have a raw score in the range 15.50 to 22.23 at Montreal cognitive assessment (MoCA);
- •Patients who have signed the informed consent and the Privacy Policy;
- •Patients who are included in cognitive stimulation programs according to regular clinical practice.
排除标准
- •Patients with the initial suspicion of MP that during the diagnostic work-up they were suffering from a different pathology;
- •Patients who have refused consent to participate in the study;
- •Patients with a diagnosis of MP and cognitive profile of dementia;
- •Patients undergoing deep brain neurostimulation (DBS-STN) treatment. Patients treated with DBS-STN were excluded because such treatment involves a surgical procedure whose effects on cognitive functioning could represent an interfering variable.
结局指标
主要结局
Efficacy of the cognitive training on cognitive function in PD patients with GBA mutation compared to a control group of PD patients without genetic mutations.
时间窗: Baseline and Six months follow-up post cognitive training
Improvement in cognitive function after eight weeks of cognitive training as measured by the battery of italian neuropsychological tests (pencil/computer paper). The neuropsychological battery consists of domain-specific cognitive tests that will provide an aggregate measure of cognitive improvement between pre and post-treatment. Higher score indicates an improvement on cognitive function.
次要结局
- The effect of cognitive training on behavioural aspects in PD patients.(Baseline and Six months follow-up post cognitive training)