Evaluating cognitive training effects in Parkinson's patients with GBA mutations
Evaluation of the Cognitive Stimulation Treatment in Patients With Parkinson's Disease
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · NCT06323278
This study tests how a specific gene mutation affects the way people with Parkinson's disease respond to brain training exercises.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 68 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico (other) |
| Locations | 1 site (Milan) |
| Trial ID | NCT06323278 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess how the GBA gene mutation influences the response to cognitive stimulation treatment in patients with Parkinson's disease. Participants will undergo neuropsychological evaluations and genetic testing before being included in cognitive stimulation programs. The study will compare the effectiveness of cognitive training between patients with the GBA mutation and those without it, while also examining the impact on behavioral aspects resulting from cognitive improvements.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with Parkinson's disease who have undergone genetic screening and meet specific cognitive assessment criteria.
Not a fit: Patients with dementia or those undergoing deep brain neurostimulation treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance cognitive training approaches for Parkinson's patients, particularly those with GBA mutations.
How similar studies have performed: While the specific approach of this study is novel, previous studies have shown cognitive training can be beneficial for Parkinson's patients, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Milan
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico — Milan, Italy (RECRUITING)
Study contacts
- Study coordinator: Fabiana Ruggiero, MSc in Psychology
- Email: fabiana.ruggiero@policlinico.mi.it
- Phone: +390255033621
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Parkinson Disease, Parkinson's Disease, GBA gene mutation, Cognitive training, Psychological and behavioral aspects