Clinical trial NCT05826548: Financial Abilities in Neurological Diseases. Development of a Telerehabilitation Program: FINAGE
Official title: Financial Abilities in Neurological Diseases. Development of a Telerehabilitation Program: FINAGE
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Mild Cognitive Impairment
Stroke
Keywords: Financial Abilities
Telerehabilitation
Cognitive rehabilitation
Changes in neurocognitive and functional domains
Lead sponsor: IRCCS San Camillo, Venezia, Italy
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Italy
name: Khymeia S.r.l.
name: Department of Neuroscience, University of Padova
First posted: 2023-04-24
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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

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.

Eligibility criteria: 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,

Primary outcomes:
measure: Correlational study
timeFrame: At baseline
measure: Measure of change in FA and cognitive abilities after a treatment with the telerehabilitation program FINAGE
timeFrame: At baseline and after 4 weeks (post-intervention)
measure: Measure of change in brain connectivity after a treatment with the telerehabilitation program FINAGE
timeFrame: At baseline and after 4 weeks (post-intervention)
Secondary outcomes:
Other outcomes:
Locations:
city: Lido Di Venezia
country: Italy
facility: IRCCS San Camillo Hospital
state: Venezia
Study officials:
affiliation: IRCCS San Camillo Hospital
name: Francesca Burgio, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: MARSON, D. C., HEBERT, K., & SOLOMON, A. C. (2011). Assessing Civil Competencies in Older Adults with Dementia. Forensic Neuropsychology: A Scientific Approach, 401.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.