Parkinson DiseaseNCT06323278
Effectiveness of Cognitive Stimulation Treatment in Patients With Parkinson's Disease
An observational study of Parkinson Disease, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Cognitive training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 68 participants
- Where
- 1 siteItaly
- Study dates
- 21 Dec 2021to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan
Fabiana Ruggiero, MSc in Psychology, +390255033621, fabiana.ruggiero@policlinico.mi.it
About this study
Official title: Evaluation of the Cognitive Stimulation Treatment in Patients With Parkinson's Disease
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
- Being tested
- Cognitive training
- Keywords
- Parkinson's Disease, GBA gene mutation, Cognitive training, Psychological and behavioral aspects
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| PD with GBA gene mutation | Patients with Parkinson's disease and GBA gene mutation treated with cognitive training Receives: Behavioral: Cognitive training | |
| PD without genetic mutation | Patients with Parkinson's disease without genetic mutation treated with cognitive training Receives: Behavioral: Cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Six months follow-up post cognitive training
Secondary outcomes (8)
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.
Measured: Baseline and Six months follow-up post cognitive training
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.
Measured: Baseline and Six months follow-up post cognitive training
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.
Measured: Baseline and Six months follow-up post cognitive training
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).
Measured: Baseline and Six months follow-up post cognitive training
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.
Measured: Baseline and Six months follow-up post cognitive training
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.
Measured: Baseline and Six months follow-up post cognitive training
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).
Measured: Baseline and Six months follow-up post cognitive training
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.
Measured: Baseline and Six months follow-up post cognitive training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start21 Dec 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06323278
- Sponsor's protocol ID
- PD&REHAB
- Status last verified
- Mar 2024
- First submitted
- 6 Mar 2024
- Last updated
- 21 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Cognitive Stimulation Treatment in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06323278
- Acronym / sponsor ID
- PD&REHAB
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's Disease, GBA gene mutation, Cognitive training, Psychological and behavioral aspects
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 21 Dec 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PD with GBA gene mutation | – | Behavioral: Cognitive trainingPatients with Parkinson's disease and GBA gene mutation treated with cognitive training |
| PD without genetic mutation | – | Behavioral: Cognitive trainingPatients with Parkinson's disease without genetic mutation treated with cognitive training |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive trainingThe 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. | Behavioural | PD with GBA gene mutation, PD without genetic mutation |
Primary outcome
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
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.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fabiana Ruggiero, MSc in Psychology (+390255033621, fabiana.ruggiero@policlinico.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2024.