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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

68 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-21

Study Completion Date

2027-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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PD with GBA gene mutation

Patients with Parkinson's disease and GBA gene mutation treated with cognitive training

Cognitive training

Intervention Type BEHAVIORAL

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.

PD without genetic mutation

Patients with Parkinson's disease without genetic mutation treated with cognitive training

Cognitive training

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No