Parkinson Disease
Conditions
Keywords
Parkinson's Disease, GBA gene mutation, Cognitive training, Psychological and behavioral aspects
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.
Interventions
BEHAVIORALCognitive training
The training, provided by normal clinical practice, will consist of two cycles of cognitive stimulation (8 sessions each) structured and aimed at maintaining and learning compensatory strategies that take advantage of the integrated cognitive skills.
Sponsors
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| The effect of cognitive training on behavioural aspects in PD patients. | Baseline and Six months follow-up post cognitive training | Cognitive Reserve (CR) is a concept based on the plasticity of the brain and an higher CR lowers the risk for incidence of dementia. The CRIq consists of 20 questions collecting demographic information, the number of years of education, and occupational and leisure activities throughout adulthood including the frequency of the activities. |
Countries
Italy
Contacts
Primary ContactFabiana Ruggiero, MSc in Psychology
Backup ContactFrancesca Mameli, MSc in Psychology
Outcome results
None listed