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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05791006
Other study ID # 25C121
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 4, 2021
Est. completion date November 30, 2024

Study information

Verified date March 2023
Source Istituto Auxologico Italiano
Contact Nadia Bolognini, PhD
Phone +39025821
Email n.bolognini@auxologico.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The present project aims to investigate the financial capacity in patients diagnosed with Parkinson's Disease or parkinsonism, brain tumor (glioma or meningioma) and cerebrovascular lesion (stroke), in order to evaluate the presence and degree of impairment, and the role of some factors as potential predictors of financial incapacity. The term 'financial capacity' means both operations relating, for example, to asset management or investing money, and activities of daily life such as shopping or using small sums of money; these activities are mediated by different cognitive functions, from numerical and arithmetic skills to decision making. Financial capacity is, in fact, an instrumental activity of daily life (i.e. Instrumental Activity Of Daily Living, I-ADL) whose impairment negatively affects the functional autonomy of the individual, so as to be subject to legal protection. To assess financial capacity, the Numerical Activities of Daily Living - Financial (NADL-F; Arcara et al., 2017) will be administered, a battery of tests aimed at investigating both financial performance and financial competence according to the most recent neuropsychological models proposed in the literature.


Recruitment information / eligibility

Status Recruiting
Enrollment 99
Est. completion date November 30, 2024
Est. primary completion date November 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - age > 18 years - Clinical diagnosis of interest for clinical groups - For stroke patients: disease duration > 1 month Exclusion Criteria: - Other brain disorders different from those of interest - Sensory-motor deficits that could prevent neuropsychological assessment - Language disorders that could prevent neuropsychological assessment - Global cognitive impairment as indexed by MoCA < 26 or MMP < 22.85

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Neuropsychological tests
Neuropsychological assessment with: NADL-F Frontal Assessment Battery (FAB) functional scales assessing activities of daily living (ADL) and instrumental activities of daily living (I-ADL) Mini-Mental Parkinson (MMP) - For Parkinson's Disease patients Montreal Cognitive Assessment (MoCA) - for brain tumor and stroke patients

Locations

Country Name City State
Italy Istituto Auxologico Italiano IRCCS Milan Lombardia

Sponsors (1)

Lead Sponsor Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Numerical Activity of Daily Living Financial (NADL-F) in Patients with Parkinson's Disease/Parkinsonisms Assessment of financial capacity; score range=0-62; higher scores indicate higher financial capacities At baseline
Primary Numerical Activity of Daily Living Financial (NADL-F) in Patients with ischemic or haemorrhagic stroke Assessment of financial capacity; score range=0-62; higher scores indicate higher financial capacities At baseline
Primary Change from baseline in Numerical Activity of Daily Living - Financial (NADL-F)Patients with brain tumors Assessment of financial capacity; score range=0-62; higher scores indicate higher financial capacities At 3 and 12 months follow up
Primary Montreal Cognitive Assessment (MoCA) Assessment of global cognitive functioning At baseline
Primary Frontal Assessment Battery (FAB) Assessment of global cognitive functioning At baseline
Primary Activities of daily living questionnaire (ADL) Assessment of function independence in everyday life At baseline
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