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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06323278
• Other study ID #: PD&REHAB
• Status: Recruiting
• Start date: December 21, 2021
• Est. completion date: December 2027

Study information

• Verified date: March 2024
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: Fabiana Ruggiero, MSc in Psychology
• Phone: +390255033621
• Email: fabiana.ruggiero[@]policlinico.mi.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: December 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The effect of cognitive training on behavioural aspects in PD patients.	Cognitive Reserve (CR) is a concept based on the plasticity of the brain and an higher CR lowers the risk for incidence of dementia. The CRIq consists of 20 questions collecting demographic information, the number of years of education, and occupational and leisure activities throughout adulthood including the frequency of the activities.	Baseline and Six months follow-up post cognitive training
Secondary	The effect of cognitive training on behavioural aspects in PD patients.	Beck Depression Inventory 2 (BDI-II): is a 21-item self-administered inventory designed to measure the intensity of depressive symptoms. Items are rated on a 4 point scale, with total scores obtained by summing the ratings for all items. Scores ranging between 0 and 13 are indicative of minimal depression. Scores ranging between 14 and 19 are indicative of mild level of depression while a score rangin from 29 to 63 is labeled severe.	Baseline and Six months follow-up post cognitive training
Secondary	The effect of cognitive training on behavioural aspects in PD patients.	Self-Rating Anxiety Sate (SAS): The SAS is a 20-item self-report assessment device built to measure anxiety levels, based on scoring in 4 groups of manifestations: cognitive, autonomic, motor and central nervous system symptoms. Each question is scored on a Likert-type scale of 1-4 (based on these replies: "a little of the time", "some of the time", "good part of the time", "most of the time"). The total raw scores range from 20 to 80. Higher score indicates higher anxiety levels.	Baseline and Six months follow-up post cognitive training
Secondary	The effect of cognitive training on behavioural aspects in PD patients.	Instrumental Activities of Daily Living (IADL): Instrumental activities of daily living (IADLs) are those activities that allow an individual to live independently in a community and can significantly improve the quality of life. The final total score ranges from 0 (low function, dependent) to 8 (high function, independent).	Baseline and Six months follow-up post cognitive training
Secondary	The effect of cognitive training on behavioural aspects in PD patients.	Instrumental Activities of Daily Living (IADL): Instrumental activities of daily living (IADLs) are those activities that allow an individual to live independently in a community and can significantly improve the quality of life. The final total score ranges from 0 (low function, dependent) to 8 (high function, independent).the higher the score, the greater the person's abilities.	Baseline and Six months follow-up post cognitive training
Secondary	The effect of cognitive training on behavioural aspects in PD patients.	IActivities of daily living (ADL): the ADL refers to activities oriented toward taking care of one's own body. These activities are fundamental to living in a social world; they enable basic survival and well-being, such as bathing, toileting, dressing and eating. Total score: between 6 (maximum performance) and 0 (lack of performance). the higher the score, the greater the person's abilities.	Baseline and Six months follow-up post cognitive training
Secondary	The effect of cognitive training on behavioural aspects in PD patients.	Visual Analog Scale (VAS) on the degree of expectation and subsequently on the degree of benefit of treatment, ranges from 0 (low benefit) to 10 (high benefit).	Baseline and Six months follow-up post cognitive training
Secondary	The effect of cognitive training on behavioural aspects in PD patients.	Parkinson's Disease Quality of Life 8 Questions (PDQ-8). The PDQ-8 is a self-administered questionnaire, used to measure quality of life in persons with Parkinson's disease. Each question is scored from 0-4 points and the scores are summed. The summed score is then divided by total possible score and given as a percentage score out of 100. A higher score represents a worse quality of life.	Baseline and Six months follow-up post cognitive training