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

Primary Purpose

Parkinson Disease, Mild Cognitive Impairment, Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Telerehabilitation group
Conventioanl treatment group
Sponsored by
IRCCS San Camillo, Venezia, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Financial Abilities, Telerehabilitation, Cognitive rehabilitation, Changes in neurocognitive and functional domains

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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,

Sites / Locations

  • IRCCS San Camillo HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Telerehabilitation group

Conventional treatment group

Arm Description

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.

The CT group will perform 4 weeks of the standard cognitive training offered by IRCCS San Camillo Hospital.

Outcomes

Primary Outcome Measures

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).
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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 16, 2023
Last Updated
April 12, 2023
Sponsor
IRCCS San Camillo, Venezia, Italy
Collaborators
Ministry of Health, Italy, Khymeia S.r.l., Department of Neuroscience, University of Padova
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1. Study Identification

Unique Protocol Identification Number
NCT05826548
Brief Title
Financial Abilities in Neurological Diseases. Development of a Telerehabilitation Program: FINAGE
Acronym
FINAGE
Official Title
Financial Abilities in Neurological Diseases. Development of a Telerehabilitation Program: FINAGE
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 11, 2021 (Actual)
Primary Completion Date
June 17, 2024 (Anticipated)
Study Completion Date
February 17, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS San Camillo, Venezia, Italy
Collaborators
Ministry of Health, Italy, Khymeia S.r.l., Department of Neuroscience, University of Padova

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: FA is impaired in neurological diseases, in different ways according to different pathologies and behavioral correlates. A telerehabilitation program for FA will be able to improve financial autonomy of MCI, Stroke and PD patients along with cognitive functions involved. 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: 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Mild Cognitive Impairment, Stroke
Keywords
Financial Abilities, Telerehabilitation, Cognitive rehabilitation, Changes in neurocognitive and functional domains

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Telerehabilitation group
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional treatment group
Arm Type
Active Comparator
Arm Description
The CT group will perform 4 weeks of the standard cognitive training offered by IRCCS San Camillo Hospital.
Intervention Type
Behavioral
Intervention Name(s)
Telerehabilitation group
Intervention Description
Patients will undergo the experimental intervention for 1 hour/day, for 5 days, for 4 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Conventioanl treatment group
Intervention Description
Patients will undergo the control intervention for 1 hour/day, for 5 days, for 4 weeks.
Primary Outcome Measure Information:
Title
Correlational study
Description
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).
Time Frame
At baseline
Title
Measure of change in FA and cognitive abilities after a treatment with the telerehabilitation program FINAGE
Description
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.
Time Frame
At baseline and after 4 weeks (post-intervention)
Title
Measure of change in brain connectivity after a treatment with the telerehabilitation program FINAGE
Description
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.
Time Frame
At baseline and after 4 weeks (post-intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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,
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francesca Burgio, PhD
Phone
0412207536
Ext
+39
Email
francesca.burgio@hsancamillo.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesca Burgio, PhD
Organizational Affiliation
IRCCS San Camillo Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS San Camillo Hospital
City
Lido Di Venezia
State/Province
Venezia
ZIP/Postal Code
30126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesca Burgio, PhD
Phone
0412207536
Ext
+39
Email
francesca.burgio@hsancamillo.it
First Name & Middle Initial & Last Name & Degree
Francesca Burgio, PhD
First Name & Middle Initial & Last Name & Degree
Andreina Giustiniani, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28880732
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.
Results Reference
background
Citation
MARSON, D. C., HEBERT, K., & SOLOMON, A. C. (2011). Assessing Civil Competencies in Older Adults with Dementia. Forensic Neuropsychology: A Scientific Approach, 401.
Results Reference
background
PubMed Identifier
12578926
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.
Results Reference
background
PubMed Identifier
19203439
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.
Results Reference
background
PubMed Identifier
19770468
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.
Results Reference
background
PubMed Identifier
32120293
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.
Results Reference
result
PubMed Identifier
33543420
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.
Results Reference
result
PubMed Identifier
34014396
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.
Results Reference
result
PubMed Identifier
34164749
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.
Results Reference
result
PubMed Identifier
35624916
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.
Results Reference
result
PubMed Identifier
35739332
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.
Results Reference
result

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

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