Effectiveness of Cognitive Stimulation Treatment in Patients With Parkinson's Disease
- Conditions
- Parkinson Disease
- Interventions
- Behavioral: Cognitive training
- Registration Number
- NCT06323278
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 68
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description PD with GBA gene mutation Cognitive training Patients with Parkinson's disease and GBA gene mutation treated with cognitive training PD without genetic mutation Cognitive training Patients with Parkinson's disease without genetic mutation treated with cognitive training
- Primary Outcome Measures
Name Time Method 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. 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.
- Secondary Outcome Measures
Name Time Method The effect of cognitive training on behavioural aspects in PD patients. Baseline and Six months follow-up post cognitive training Parkinson's Disease Quality of Life 8 Questions (PDQ-8). The PDQ-8 is a self-administered questionnaire, used to measure quality of life in persons with Parkinson's disease. Each question is scored from 0-4 points and the scores are summed. The summed score is then divided by total possible score and given as a percentage score out of 100. A higher score represents a worse quality of life.
Trial Locations
- Locations (1)
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
🇮🇹Milan, Italy