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

NCT06323278 | Recruiting

• 1 other identifier: PD&REHAB
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Parkinson's Disease; GBA gene mutation; Cognitive training; Psychological and behavioral aspects

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  Baseline and Six months follow-up post cognitive training

Secondary Outcomes (8)

• The effect of cognitive training on behavioural aspects in PD patients.

  Baseline and Six months follow-up post cognitive training

• The effect of cognitive training on behavioural aspects in PD patients.

  Baseline and Six months follow-up post cognitive training

• The effect of cognitive training on behavioural aspects in PD patients.

  Baseline and Six months follow-up post cognitive training

• The effect of cognitive training on behavioural aspects in PD patients.

  Baseline and Six months follow-up post cognitive training

• The effect of cognitive training on behavioural aspects in PD patients.

  Baseline and Six months follow-up post cognitive training

Study Arms (2)

PD with GBA gene mutation

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

Behavioral: Cognitive training

PD without genetic mutation

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

Behavioral: Cognitive training

Interventions

Cognitive training 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 with GBA gene mutation; PD without genetic mutation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* Experimental group: 34 PD patients with GBA gene mutation and undergoing cognitive stimulation treatment; * Control group: 34 patients with idiopathic PD without known genetic mutation undergoing cognitive stimulation treatment. The allocation of subjects to the two groups will be paired (1:1) by age ( 2 aa), sex, staging and duration of the disease.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Fabiana Ruggiero, MSc in Psychology

CONTACT

+390255033621; fabiana.ruggiero@policlinico.mi.it

Francesca Mameli, MSc in Psychology

CONTACT

+390255033621; francesca.mameli@policlinico.mi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 21, 2024
• Study Start: December 21, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 21, 2024

Record last verified: 2024-03

Locations

IT (1)