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Clinical Trials in Italy / NCT06323278
Recruiting Observational

Effectiveness of Cognitive Stimulation Treatment in Patients With Parkinson's Disease

NCT06323278 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Phase
Observational
Started
2021-12-21
Last updated
2024-03-21

Condition(s) studied

Parkinson Disease

Investigational drug(s) / intervention(s)

Cognitive training

Cognitive 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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
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.

Primary outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan Italy Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06323278 on ClinicalTrials.gov ↗ ← All trials in Italy