Financial Abilities in Neurological Diseases. Development of a Telerehabilitation Program: FINAGE (FINAGE)

October 4, 2024 updated by: Francesca Burgio, IRCCS San Camillo, Venezia, Italy
Financial Abilities (FA) are a set of capacities that allow a person to independently manage her/his financial affairs in a manner consistent with personal self-interests and values. This project will: a) assess Financial Abilities in different neurological conditions: Mild Cognitive Impairment, Parkinson's disease and Stroke patients; b) investigate both cognitive correlations, specifically the role of executive functions, thought to be critically involved in the FA multi-dimensional concept, and neuro-anatomical correlates of Financial Abilities; c) build a rehabilitation tool in order to improve FA. Secondary aims are to apply this rehabilitation tool at long distance and evaluate its behavioral, functional and neuroanatomical effects. The starting point for this project is the recently published NADL-F - Numerical Activities of Daily Living - Financial, a multi-domain ecological battery aimed at assessing FA in healthy people as well as in neurological patient populations

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Financial Abilities (FA) have recently been defined as the capacity to manage money and financial assets in ways that meet a person's needs and which are consistent with her/his values and self-interests. The loss of this capacity can have serious legal, economical, and personal consequences on the individual. The social consequences of maintaining financial abilities are also of pivotal importance. A clear example is given by patients at risk of dementia; the more the population ages, the more the prevalence of dementia increases, and cognitive decline is bound to also affect FA. Moreover, older adults hold a comparatively high share of a nation's wealth. Thus, impairments in FA encountered in this part of the population may also be a risk to the whole society. Only a few studies investigated the neural correlates of FA, focusing mainly on pathological aging. The exact behavioral correlates of decline in this particular domain and the precise relation of unwise financial decisions with the deterioration of anatomical structures are still poorly understood. This may raise the fundamental question of when and why, in relation to neural decline, an individual's FA becomes impaired. The present project addresses both of these problems. The ability to deal with financial matters may differ according to the type of neurological diseases present. Specific anatomical damage, rather than the etiology, may in fact be a better predictor of behavior. Investigating the neural correlates of FA, orthogonally to pathology, is therefore an aim of the present project. Critically, most studies conducted so far analyzed only a few brain regions, which may be restrictive considering the multidimensional nature of FA that presumably draws upon numerous brain networks, cortical hubs, and associated cognitive and emotional processes. A first aim of the present project is to make up for this shortcoming by administering and correlating NADL-F performance with a cognitive assessment and neuroimaging investigation. Studying anatomical correlates of FA, however, is, in the present project, only instrumental in reaching the overarching and final aim of this proposal, which is, building a valid and practical rehabilitation tool. Such a tool shall induce long term positive modifications based on neural plasticity. Understanding the working of such a tool by comparing which brain areas are recruited before and after the rehabilitation program would provide invaluable information. A crucial aspect will be the possibility of administering rehabilitation remotely. Independent measures of the translational value of the treatment will be applied.

Hyphotesis and Significance:

  1. FA is impaired in neurological diseases, in different ways according to different pathologies and behavioral correlates.
  2. A telerehabilitation program for FA will be able to improve financial autonomy of MCI, Stroke and PD patients along with cognitive functions involved.
  3. FA has specific neural correlates, which could be selectively and differently impaired in various neurological pathologies. Moreover, the improvement of FA after the telerehabilitation program would be related to a plastic cerebral reorganization after FA training.

Aims:

  1. To investigate FA deficit patterns, by means of NADL-Financial battery, in Parkinson's Disease (PD) and Stroke patients, for which FA deficits were preliminarily observed. These hypotheses are also based on findings on MCI group study, conducted on a numerous sample (N=51). For these reasons, this project aims at extending the preliminary data to Stroke and PD patients' groups. In particular, the study is interested in investigating the specific role played by executive functions and the interaction of FA with numerical functions such as processing and understanding of ratio concepts (%, 3/4, ...), which are important to make advantageous decisions under risk and choose the most optimal financial options.
  2. To design and study the efficacy of a telerehabilitation protocol. The protocol will be focused on the improvement of financial abilities and related cognitive domains. The rehabilitation study will include the pathologies investigated in Aim 1 (PD and Stroke) and MCI population.
  3. To carry out a neuroimaging study, with the following sub-goals: a) to analyze the neuroanatomical correlates of FA in PD and Stroke patients; b) to explore expected neuroanatomical and neurofunctional changes, due to rehabilitation, in PD, Stroke and MCI patients.

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Not Applicable

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 Locations

  • Italy
    • Venezia
      • Lido Di Venezia, Venezia, Italy, 30126
        • Recruiting
        • IRCCS San Camillo Hospital
        • Contact:
        • Contact:
          • Francesca Burgio, PhD
        • Contact:
          • Andreina Giustiniani, PhD

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • diagnosis of: Mild Cognitive Impairment, Parkinson's disease and stroke
  • preserved use of at least one hand,
  • normal or corrected to normal vision

Exclusion Criteria:

  • history of psychiatric and/or concurrent neurological diseases
  • inability to provide informed consent,
  • impaired comprehension of oral instructions,

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telerehabilitation group
The TR group will perform 4 weeks of cogntiive training using the FINAGE tablet. The rehabilitation tasks will train the patients on the detected FA deficits, but also on the cognitive domains underlying such abilities. FINAGE TR program will have a modular structure, with 8 different packages including AF and: language, attention, memory, numbers, logical reasoning, executive functions, theory of mind and testamentary capacities. Every package will involve exercises of increasing difficulty. Reaction times, number of stimuli presented and other parameters will be customizable, in order to be adaptable to different patients' cognitive conditions and/or to their achievements from one session to the other.
Behavioral: Telerehabilitation group
Patients will undergo the experimental intervention for 1 hour/day, for 5 days, for 4 weeks.
Active Comparator: Conventional treatment group
The CT group will perform 4 weeks of the standard cognitive training offered by IRCCS San Camillo Hospital.
Behavioral: Conventioanl treatment group
Patients will undergo the control intervention for 1 hour/day, for 5 days, for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlational study
Time Frame: At baseline

Performances at the NADL-F battery, assessing financial abilities, will be correlated to cognitive performances as assessed by a full neuropsychological battery encompassing the main cognitive domain, such as memory, attention, executive function, language, visuospatial abilities. Specific neuropsychological tests will be defined on the basis of the specific neurological population.

Raw scores at each test will be converted in z-scores based on each test normative data. Z-scores will be averaged to calculate composite scores specific for each cognitive domain. In detail, the composite scores will be the following: general cognitive functioning, attention, executive function, short-term memory, long-term memory, visuospatial abilities, language.

NADL-F scores will be then correlated also with structural (e.g., lesion mapping and/or voxel based morphometry) and functional measures (e.g., functional brain network connectivity).
At baseline
Measure of change in FA and cognitive abilities after a treatment with the telerehabilitation program FINAGE
Time Frame: At baseline and after 4 weeks (post-intervention)

The telerehabilitation program will be implemented on tablets (FINAGE). Exercises will focus on language, attention, memory, calculation, reasoning, gambling, executive function, theory of mind, testamentary abilities. Patients will complete 20 daily 1-hour sessions.

Half of the patients will undergo the rehabilitation with FINAGE, the other half 20 sessions of standard cognitive rehabilitation.

Cognitive performances will be assessed before and after treatment by a neuropsychological battery encompassing the main cognitive domains. Specific neuropsychological tests will be defined on the basis of the specific neurological population. Raw scores at each test will be converted in z-scores based on each test normative data. Z-scores will be averaged to calculate composite scores for each cognitive domain. The composite scores will be the following: general cognitive functioning, attention, executive function, short-term memory, long-term memory, visuospatial abilities, language.
At baseline and after 4 weeks (post-intervention)
Measure of change in brain connectivity after a treatment with the telerehabilitation program FINAGE
Time Frame: At baseline and after 4 weeks (post-intervention)
Patients will undergo a session of fMRI before and after treatment. The following variables will be extracted by neuroimaging data: whole-brain T1-based structural (surface, area, gyrification estimation in FreeSerfer) and resting-state fMRI-based functional connectivity (through Independent Component Analysis) properties of the main brain networks such as the fronto-parietal network, dorsal and ventral attention, salience and default-mode networks. MRI volumetric measurement (using automated routines in SPM12) of ROIs that previous literature has suggested to be linked to FA, at least in MCI, such as the angular gyri, will also be performed. Between subject independent variables will be pathology (PD, Stroke and MCI), type of treatment (TR, CT) and, when appropriate, session (pre- and post-treatment) will also be considered as the within-subject independent variable.
At baseline and after 4 weeks (post-intervention)

Collaborators and Investigators

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

Sponsor

IRCCS San Camillo, Venezia, Italy

Collaborators

Ministry of Health, Italy
Khymeia S.r.l.
Department of Neuroscience, University of Padova

Investigators

  • Principal Investigator: Francesca Burgio, PhD, IRCCS San Camillo Hospital

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)

March 11, 2021

Primary Completion (Estimated)

December 17, 2024

Study Completion (Estimated)

February 17, 2025

Study Registration Dates

First Submitted

March 16, 2023

First Submitted That Met QC Criteria

April 12, 2023

First Posted (Actual)

April 24, 2023

Study Record Updates

Last Update Posted (Actual)

October 8, 2024

Last Update Submitted That Met QC Criteria

October 4, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019.08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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