Effectiveness of Cognitive Stimulation Treatment in Patients With Parkinson's Disease
Recruiting · NCT06323278 · Observational (researchers observe without assigning treatment) · Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where it is running
1 location listed.
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Milan, Italy