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

NCT05826548 | Recruiting DMC

• 1 other identifier: 2019.08
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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

Conditions

Parkinson Disease; Mild Cognitive Impairment; Stroke

Keywords

Financial Abilities; Telerehabilitation; Cognitive rehabilitation; Changes in neurocognitive and functional domains

Outcome Measures

Primary Outcomes (3)

• 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).

  At baseline

• 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.

  At baseline and after 4 weeks (post-intervention)

• 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.

  At baseline and after 4 weeks (post-intervention)

Study Arms (2)

Telerehabilitation group

EXPERIMENTAL

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

Conventional treatment group

ACTIVE COMPARATOR

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

Behavioral: Conventioanl treatment group

Interventions

Telerehabilitation group BEHAVIORAL

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

Telerehabilitation group

Conventioanl treatment group BEHAVIORAL

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

Conventional treatment group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS San Camillo, Venezia, Italy: lead
• Ministry of Health, Italy: collaborator
• Khymeia S.r.l.: collaborator
• Department of Neuroscience, University of Padova: collaborator

Study Sites (1)

IRCCS San Camillo Hospital

Lido, Venezia, 30126, Italy

RECRUITING

Related Publications (11)

• 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.

  PMID: 28880732 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 12578926 BACKGROUND

• 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.

  PMID: 19203439 BACKGROUND

• 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.

  PMID: 19770468 BACKGROUND

• 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.

  PMID: 32120293 BACKGROUND

• 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.

  PMID: 33543420 BACKGROUND

• 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.

  PMID: 34014396 BACKGROUND

• 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.

  PMID: 34164749 BACKGROUND

• 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.

  PMID: 35624916 BACKGROUND

• 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.

  PMID: 35739332 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Cognitive Dysfunction; Stroke

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Francesca Burgio, PhD

  IRCCS San Camillo Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesca Burgio, PhD

CONTACT

0412207536; francesca.burgio@hsancamillo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher, Psychologist, Psychotherapist

Model Details: 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.

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: April 24, 2023
• Study Start: March 11, 2021
• Primary Completion: December 17, 2024
• Study Completion: February 17, 2025
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)