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Recruiting NCT06323278

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

— Observational Parkinson Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cognitive training.
Who it may be relevant to
Registry conditions: Parkinson Disease. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Evaluation of the Cognitive Stimulation Treatment in Patients With Parkinson's Disease

Overview

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

  • Behavioral 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.

Primary outcome measures

  • 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. [Time frame: Baseline and Six months follow-up post cognitive training]
Secondary outcome measures (8)
  • The effect of cognitive training on behavioural aspects in PD patients. [Time frame: Baseline and Six months follow-up post cognitive training]
  • The effect of cognitive training on behavioural aspects in PD patients. [Time frame: Baseline and Six months follow-up post cognitive training]
  • The effect of cognitive training on behavioural aspects in PD patients. [Time frame: Baseline and Six months follow-up post cognitive training]
  • The effect of cognitive training on behavioural aspects in PD patients. [Time frame: Baseline and Six months follow-up post cognitive training]
  • The effect of cognitive training on behavioural aspects in PD patients. [Time frame: Baseline and Six months follow-up post cognitive training]
  • The effect of cognitive training on behavioural aspects in PD patients. [Time frame: Baseline and Six months follow-up post cognitive training]
  • The effect of cognitive training on behavioural aspects in PD patients. [Time frame: Baseline and Six months follow-up post cognitive training]
  • The effect of cognitive training on behavioural aspects in PD patients. [Time frame: Baseline and Six months follow-up post cognitive training]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico — Milan

Identifiers

NCT: NCT06323278 · PD&REHAB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗