Neuropsychology of Financial Capacity (NEUROFIN)

March 16, 2023 updated by: Istituto Auxologico Italiano

The present project aims to investigate the financial capacity in patients diagnosed with Parkinson's Disease or parkinsonism, brain tumor (glioma or meningioma) and cerebrovascular lesion (stroke), in order to evaluate the presence and degree of impairment, and the role of some factors as potential predictors of financial incapacity.

The term 'financial capacity' means both operations relating, for example, to asset management or investing money, and activities of daily life such as shopping or using small sums of money; these activities are mediated by different cognitive functions, from numerical and arithmetic skills to decision making. Financial capacity is, in fact, an instrumental activity of daily life (i.e. Instrumental Activity Of Daily Living, I-ADL) whose impairment negatively affects the functional autonomy of the individual, so as to be subject to legal protection.

To assess financial capacity, the Numerical Activities of Daily Living - Financial (NADL-F; Arcara et al., 2017) will be administered, a battery of tests aimed at investigating both financial performance and financial competence according to the most recent neuropsychological models proposed in the literature.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
99

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
    • Lombardia
      • Milan, Lombardia, Italy, 20122
        • Recruiting
        • Istituto Auxologico Italiano IRCCS
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

  • Patients with Parkinson's Disease/parkinsonisms
  • Patients with brain tumor
  • Patients with stroke
  • Healthy controls

Description

Inclusion Criteria:

  • age > 18 years
  • Clinical diagnosis of interest for clinical groups
  • For stroke patients: disease duration > 1 month

Exclusion Criteria:

  • Other brain disorders different from those of interest
  • Sensory-motor deficits that could prevent neuropsychological assessment
  • Language disorders that could prevent neuropsychological assessment
  • Global cognitive impairment as indexed by MoCA < 26 or MMP < 22.85

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Healthy Controls
Behavioral: Neuropsychological tests

Neuropsychological assessment with:

  • NADL-F
  • Frontal Assessment Battery (FAB)
  • functional scales assessing activities of daily living (ADL) and instrumental activities of daily living (I-ADL)
  • Mini-Mental Parkinson (MMP) - For Parkinson's Disease patients
  • Montreal Cognitive Assessment (MoCA) - for brain tumor and stroke patients
Patients with brain tumors
Behavioral: Neuropsychological tests

Neuropsychological assessment with:

  • NADL-F
  • Frontal Assessment Battery (FAB)
  • functional scales assessing activities of daily living (ADL) and instrumental activities of daily living (I-ADL)
  • Mini-Mental Parkinson (MMP) - For Parkinson's Disease patients
  • Montreal Cognitive Assessment (MoCA) - for brain tumor and stroke patients
Patients with Parkinson's Disease/Parkinsonisms
Behavioral: Neuropsychological tests

Neuropsychological assessment with:

  • NADL-F
  • Frontal Assessment Battery (FAB)
  • functional scales assessing activities of daily living (ADL) and instrumental activities of daily living (I-ADL)
  • Mini-Mental Parkinson (MMP) - For Parkinson's Disease patients
  • Montreal Cognitive Assessment (MoCA) - for brain tumor and stroke patients
Patients with ischemic or haemorrhagic stroke
Behavioral: Neuropsychological tests

Neuropsychological assessment with:

  • NADL-F
  • Frontal Assessment Battery (FAB)
  • functional scales assessing activities of daily living (ADL) and instrumental activities of daily living (I-ADL)
  • Mini-Mental Parkinson (MMP) - For Parkinson's Disease patients
  • Montreal Cognitive Assessment (MoCA) - for brain tumor and stroke patients

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Numerical Activity of Daily Living Financial (NADL-F) in Patients with Parkinson's Disease/Parkinsonisms
Time Frame: At baseline
Assessment of financial capacity; score range=0-62; higher scores indicate higher financial capacities
At baseline
Numerical Activity of Daily Living Financial (NADL-F) in Patients with ischemic or haemorrhagic stroke
Time Frame: At baseline
Assessment of financial capacity; score range=0-62; higher scores indicate higher financial capacities
At baseline
Change from baseline in Numerical Activity of Daily Living - Financial (NADL-F)Patients with brain tumors
Time Frame: At 3 and 12 months follow up
Assessment of financial capacity; score range=0-62; higher scores indicate higher financial capacities
At 3 and 12 months follow up
Montreal Cognitive Assessment (MoCA)
Time Frame: At baseline
Assessment of global cognitive functioning
At baseline
Frontal Assessment Battery (FAB)
Time Frame: At baseline
Assessment of global cognitive functioning
At baseline
Activities of daily living questionnaire (ADL)
Time Frame: At baseline
Assessment of function independence in everyday life
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istituto Auxologico Italiano

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 4, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 5, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 25C121

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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