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Parkinson DiseaseFINAGENCT05826548

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

A study testing Telerehabilitation group and Conventioanl treatment group in people with Parkinson Disease and Mild Cognitive Impairment, run by IRCCS San Camillo, Venezia, Italy at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
Telerehabilitation group and Conventioanl treatment group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
1 siteItaly
Study dates
11 Mar 2021to 17 Feb 2025
Phase
Interventional
Are there results?
None posted in the registry

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 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Francesca Burgio, PhD contact

0412207536 ext. +39

francesca.burgio@hsancamillo.it

Italy1 site, 1 recruiting

  • IRCCS San Camillo Hospital

    Lido, Venezia, 30126

    Francesca Burgio, PhD, 0412207536 ext. +39, francesca.burgio@hsancamillo.it

    Francesca Burgio, PhD

    Recruiting

Other trials in Italy

About this study

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

Read the 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.
Being tested
Telerehabilitation group, Conventioanl treatment group
Keywords
Financial Abilities, Telerehabilitation, Cognitive rehabilitation, Changes in neurocognitive and functional domains
Medical subject headings
Parkinson Disease, Cognitive Dysfunction, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telerehabilitation groupBehavioural

    Patients will undergo the experimental intervention for 1 hour/day, for 5 days, for 4 weeks.

  • Conventioanl treatment groupBehavioural

    Patients will undergo the control intervention for 1 hour/day, for 5 days, for 4 weeks.

Study groups in NCT05826548
Study groupRoleWhat they receive
Telerehabilitation groupExperimentalThe 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.
Receives: Behavioral: Telerehabilitation group
Conventional treatment groupActive comparatorThe CT group will perform 4 weeks of the standard cognitive training offered by IRCCS San Camillo Hospital.
Receives: Behavioral: Conventioanl treatment group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Correlational study

    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).

    Measured: At baseline

  2. Measure of change in FA and cognitive abilities after a treatment with the telerehabilitation program FINAGE

    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.

    Measured: At baseline and after 4 weeks (post-intervention)

  3. Measure of change in brain connectivity after a treatment with the telerehabilitation program FINAGE

    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.

    Measured: At baseline and after 4 weeks (post-intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2023
  2. Study start11 Mar 2021
  3. Primary completion17 Dec 2024 (estimated)
  4. Study completion17 Feb 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
PD, Stroke and MCI patients will be recruited in the IRCCS San Camillo Hospital. The selection will be based on diagnosis made by an expert neurologist and on a neuropsychological evaluation. Enrolled patients will be randomized in two groups and by using a block randomization sequence (Random.org), to receive telerehabilitation treatment (TR; N=70) or conventional treatment (CT; N=70). The CT group will undergo the standard cognitive training offered by the Hospital. The TR group will perform 5 daily sessions, 1 hour each, per week: 3 online, together with a remote therapist, and 2 offline that the therapist will be able to set and control in every moment, from a PC-based workstation in the hospital. The trainings will last 4 weeks.
Masking
Single blind
Who is masked
Participant
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05826548
Sponsor's protocol ID
2019.08
Acronym
FINAGE
Status last verified
Oct 2024
First submitted
16 Mar 2023
Last updated
8 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Arcara G, Burgio F, Benavides-Varela S, Toffano R, Gindri P, Tonini E, Meneghello F, Semenza C. Numerical Activities of Daily Living - Financial (NADL-F): A tool for the assessment of financial capacities double dagger. Neuropsychol Rehabil. 2019 Aug;29(7):1062-1084. doi: 10.1080/09602011.2017.1359188. Epub 2017 Sep 7.

    PubMed 28880732

  • MARSON, D. C., HEBERT, K., & SOLOMON, A. C. (2011). Assessing Civil Competencies in Older Adults with Dementia. Forensic Neuropsychology: A Scientific Approach, 401.

  • Griffith HR, Belue K, Sicola A, Krzywanski S, Zamrini E, Harrell L, Marson DC. Impaired financial abilities in mild cognitive impairment: a direct assessment approach. Neurology. 2003 Feb 11;60(3):449-57. doi: 10.1212/wnl.60.3.449.

    PubMed 12578926

  • Sherod MG, Griffith HR, Copeland J, Belue K, Krzywanski S, Zamrini EY, Harrell LE, Clark DG, Brockington JC, Powers RE, Marson DC. Neurocognitive predictors of financial capacity across the dementia spectrum: Normal aging, mild cognitive impairment, and Alzheimer's disease. J Int Neuropsychol Soc. 2009 Mar;15(2):258-67. doi: 10.1017/S1355617709090365. Epub 2009 Feb 10.

    PubMed 19203439

  • Triebel KL, Martin R, Griffith HR, Marceaux J, Okonkwo OC, Harrell L, Clark D, Brockington J, Bartolucci A, Marson DC. Declining financial capacity in mild cognitive impairment: A 1-year longitudinal study. Neurology. 2009 Sep 22;73(12):928-34. doi: 10.1212/WNL.0b013e3181b87971.

    PubMed 19770468

  • Benavides-Varela S, Burgio F, Weis L, Mitolo M, Palmer K, Toffano R, Arcara G, Vallesi A, Mantini D, Meneghello F, Semenza C. The role of limbic structures in financial abilities of mild cognitive impairment patients. Neuroimage Clin. 2020;26:102222. doi: 10.1016/j.nicl.2020.102222. Epub 2020 Feb 19.

    PubMed 32120293

  • Toffano R, Burgio F, Palmer K, Benavides-Varela S, Meneghello F, Orru G, Sartori G, Arcara G, Semenza C. Numerical Activities of Daily Living - Financial: a short version. Neurol Sci. 2021 Oct;42(10):4183-4191. doi: 10.1007/s10072-021-05047-y. Epub 2021 Feb 5.

    PubMed 33543420

  • Burgio F, Benavides-Varela S, Toffano R, Palmer K, Meneghello F, Arcara G, Semenza C. Predicting financial deficits from a standard neuropsychological assessment: preliminary evidence in mild cognitive impairment. Neurol Sci. 2022 Jan;43(1):299-303. doi: 10.1007/s10072-021-05304-0. Epub 2021 May 20.

    PubMed 34014396

  • Burgio F, Danesin L, Benavides-Varela S, Meneghello F, Butterworth B, Arcara G, Semenza C. Numerical activities of daily living: a short version. Neurol Sci. 2022 Feb;43(2):967-978. doi: 10.1007/s10072-021-05391-z. Epub 2021 Jun 23.

    PubMed 34164749

  • Danesin L, Giustiniani A, Arcara G, Burgio F. Financial Decision-Making in Neurological Patients. Brain Sci. 2022 Apr 21;12(5):529. doi: 10.3390/brainsci12050529.

    PubMed 35624916

  • Burgio F, Filippini N, Weis L, Danesin L, Ferrazzi G, Garon M, Biundo R, Facchini S, Antonini A, Benavides-Varela S, Semenza C, Arcara G. Neurocognitive correlates of numerical abilities in Parkinson's disease. Neurol Sci. 2022 Sep;43(9):5313-5322. doi: 10.1007/s10072-022-06228-z. Epub 2022 Jun 23.

    PubMed 35739332

Questions about this trial

What is this clinical trial studying?

A study testing Telerehabilitation group and Conventioanl treatment group in people with Parkinson Disease and Mild Cognitive Impairment, run by IRCCS San Camillo, Venezia, Italy 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 8 Oct 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Francesca Burgio, PhD (0412207536 ext. +39, francesca.burgio@hsancamillo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlational study (time frame: At baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05826548, which also lists 11 linked publications.

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 8 Oct 2024.

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