Development, Validation and Normative Data of the Italian Battery for the Recognition of Famous Faces (FAME) (I-FACE)
Sviluppo, Validazione e Dati Normativi Della Batteria Italiana Per il Riconoscimento Dei Volti Famosi I-FACE
The I-FACE project aims to develop and validate a battery to assess famous-face recognition in people with neurodegenerative diseases and stroke. It will examine face naming, familiarity, and semantic knowledge, establish norms for the Italian population, and test how well the measures identify recognition difficulties in patients with frontotemporal dementia, Alzheimer's disease, and stroke.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
The I-FACE project aims to develop and clinically validate a comprehensive neuropsychological battery for assessing famous-face recognition in people with neurodegenerative diseases and in stroke survivors. Face-recognition difficulties can affect a person's ability to identify familiar individuals and access information about them, yet these abilities are not always assessed systematically in clinical practice.
The battery will examine three components of famous-face recognition: Familiarity, or knowing that a face has been seen before; semantic knowledge, or retrieving information such as the person's profession; and naming, or producing the person's name. It will include four tasks: Famous Faces Confrontation Naming (FFCN), Famous Faces Semantic Association based on profession (FFSA), Famous Faces Triplet Words (FFTW), which assesses semantic associations using written names, and the Famous Faces Familiarity Judgement Task (FFFJT).
A pilot study will be used to refine the tasks and select items with good internal consistency. The researchers will then collect normative data from Italian participants, considering age, sex, and educational level, and establish cut-off scores for each subtest. Finally, the battery will be administered to people with frontotemporal dementia, Alzheimer's disease, and stroke to assess its reliability and validity. Its ability to distinguish patients with face-recognition impairments from healthy individuals will be evaluated using measures including sensitivity, specificity, and ROC curve analyses. The overall aim is to provide a reliable tool for identifying and characterizing these difficulties, including subtle deficits that may support earlier and more accurate clinical assessment.
Typ studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Petronilla Battista, PhD
- Numer telefonu: +39 0807814331
- E-mail: petronilla.battista@icsmaugeri.it
Kopia zapasowa kontaktu do badania
- Nazwa: Serena Tagliente, MSc
- Numer telefonu: +39 0807814331
- E-mail: serena.tagliente@icsmaugeri.it
Lokalizacje studiów
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Bari, Włochy, 70124
- Rekrutacyjny
- Istituti Clinici Scientifici Maugeri IRCCS Bari
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Kontakt:
- Stefania De Trane, MD
- E-mail: stefania.detrane@icsmaugeri.it
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Kontakt:
- Serena Tagliente, MSc
- Numer telefonu: +390807814331
- E-mail: serena.tagliente@icsmaugeri.it
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Milan, Włochy, 20138
- Rekrutacyjny
- Istituti Clinici Scientifici Maugeri IRCCS Milano
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Kontakt:
- Christian Lunetta, MD
- Numer telefonu: +39 02 5072 5266
- E-mail: christian.lunetta@icsmaugeri.it
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Kontakt:
- Claudia Bossi, MSc
- Numer telefonu: +39 0382 592048
- E-mail: claudia.bossi@icsmaugeri.it
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Pod-śledczy:
- Debora Pain, MSc
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Pavia, Włochy, 27100
- Rekrutacyjny
- IRCCS Maugeri Pavia
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Kontakt:
- Marina Manera, MSc
- Numer telefonu: 0382 592952
- E-mail: marina.manera@icsmaugeri.it
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Telese Terme, Włochy, 82037
- Rekrutacyjny
- IRCCS Maugeri Telese Terme
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Kontakt:
- Pasquale Moretta, MSc
- Numer telefonu: +39 0824 909111
- E-mail: pasquale.moretta@icsmaugeri.it
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Veruno, Włochy, 28013
- Jeszcze nie rekrutacja
- IRCCS Maugeri Veruno
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Kontakt:
- Giusy Figliano, PhD
- Numer telefonu: 0322 884711
- E-mail: giusi.figliano@icsmaugeri.it
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AG
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Sciacca, AG, Włochy, 92019
- Rekrutacyjny
- ICS Maugeri Sciacca
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Kontakt:
- Stefania Ruvolo, MSc
- E-mail: stefania.ruvolo@icsmaugeri.it
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BS
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Lumezzane, BS, Włochy, 25065
- Rekrutacyjny
- IRCCS Maugeri Lumezzane
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Kontakt:
- Lidia Gazzi, MSc
- Numer telefonu: +39 030 825 3011
- E-mail: lidia.gazzi@icsmaugeri.it
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Kontakt:
- Gaia C Santi, PhD
- Numer telefonu: +39 030 825 3011
- E-mail: gaia.santi@icsmaugeri.it
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ME
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Mistretta, ME, Włochy, 98073
- Rekrutacyjny
- ICS Maugeri Mistretta
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Kontakt:
- Luisa Scaduto, MSc
- Numer telefonu: 0921 389111
- E-mail: luisa.scaduto@icsmaugeri.it
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MN
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Castel Goffredo, MN, Włochy, 46042
- Jeszcze nie rekrutacja
- IRCCS Maugeri Castel Goffredo
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Kontakt:
- Giuliana Vezzadini, MD
- E-mail: giuliana.vezzadini@icsmaugeri.it
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PV
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Montescano, PV, Włochy, 27040
- Rekrutacyjny
- IRCCS Maugeri Montescano
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Kontakt:
- Antonia Pierobon, MSc
- Numer telefonu: 0385 2471
- E-mail: antonia.pierobon@icsmaugeri.it
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
The study will include adults aged 40-85 years in four groups: healthy controls, participants with probable frontotemporal dementia (FTD), participants with probable Alzheimer's disease (AD), and participants assessed in the subacute phase after stroke (1 week to 3 months after the event). Stroke must be ischemic or hemorrhagic and confirmed by neuroimaging and/or clinical assessment. Participants will be recruited from the study's clinical setting and assessed using the I-FACE neuropsychological battery. Group-specific eligibility criteria will be applied.
Opis
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Healthy Controls (HC)
Inclusion Criteria:
Age 40-85 years. No chronic medical, neurological, or psychiatric conditions, or major depressive episode detected during screening.
No history of schizophrenia or bipolar disorder in the 5 years prior to screening.
Mini-Mental State Examination (MMSE) score ≥ 26.
Exclusion Criteria:
Uncorrected vision or hearing impairment.
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Frontotemporal Dementia (FTD) Patients
Inclusion Criteria:
Diagnosis of probable FTD according to established clinical criteria. Age 40-85 years. Ability to provide informed consent.
Exclusion Criteria:
History of neurological diseases other than FTD (e.g., stroke, brain tumor, multiple sclerosis, traumatic brain injury).
Uncorrected vision or hearing impairment. History of serious psychiatric diseases, developmental disorders (e.g., autism spectrum), or intellectual disability.
Dementia severity (CDR) > 1.
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Alzheimer's Disease (AD) Patients
Inclusion Criteria:
Diagnosis of probable AD according to established clinical criteria. Age 40-85 years. Ability to provide informed consent.
Exclusion Criteria:
History of neurological diseases other than AD (e.g., stroke, brain tumor, multiple sclerosis, traumatic brain injury).
Uncorrected vision or hearing impairment. History of serious psychiatric diseases, developmental disorders, or intellectual disability.
Dementia severity (CDR) > 1.
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Post-Stroke Patients
Inclusion Criteria:
Subacute phase: 1 week to 3 months post-event. Ischemic or hemorrhagic stroke confirmed by neuroimaging and/or clinical judgment.
Exclusion Criteria:
History of previous stroke or multifocal stroke documented by imaging. Brainstem or cerebellar stroke. History of traumatic brain injury (TBI), seizures, brain tumors, neurodegenerative diseases, or psychiatric disorders.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Modele obserwacyjne: COHORT
- Perspektywy czasowe: PROSPECTIVE
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
|
Healthy controls
Control participants will be administered the experimental neuropsychological battery to establish normative data. |
Participants will complete the I-FACE neuropsychological assessment battery as outlined in the study protocol. The assessment includes standardised cognitive tests and questionnaires to evaluate the relevant cognitive domains. Participants will complete it once, and it does not involve therapeutic treatment or an investigational drug. |
|
Patients with Alzheimer's disease
Patients with AD will be administered the experimental neuropsychological battery to establish the clinical validity of the FAME |
Participants will complete the I-FACE neuropsychological assessment battery as outlined in the study protocol. The assessment includes standardised cognitive tests and questionnaires to evaluate the relevant cognitive domains. Participants will complete it once, and it does not involve therapeutic treatment or an investigational drug. |
|
Patients with Frontotemporal dementia
Patients with FTD will be administered the experimental neuropsychological battery to establish the clinical validity of the FAME |
Participants will complete the I-FACE neuropsychological assessment battery as outlined in the study protocol. The assessment includes standardised cognitive tests and questionnaires to evaluate the relevant cognitive domains. Participants will complete it once, and it does not involve therapeutic treatment or an investigational drug. |
|
Post-stroke survivors
Post-stroke survivors will be administered the experimental neuropsychological battery to establish the clinical validity of the FAME |
Participants will complete the I-FACE neuropsychological assessment battery as outlined in the study protocol. The assessment includes standardised cognitive tests and questionnaires to evaluate the relevant cognitive domains. Participants will complete it once, and it does not involve therapeutic treatment or an investigational drug. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
I-FACE total and subtest scores
Ramy czasowe: From enrollment to the end of neuropsychologic assessment (Day 1)
|
Participant performance on the four I-FACE tasks assessing famous-face naming, semantic association from faces, familiarity judgment, and semantic association from written names. Each item is scored 0 (incorrect/not identified) or 1 (correctly identified); total scores are calculated for each subtest. |
From enrollment to the end of neuropsychologic assessment (Day 1)
|
Współpracownicy i badacze
Śledczy
- Główny śledczy: Petronilla Battista, PhD, Istituti Clinici Scientifici Maugeri IRCCS
Publikacje i pomocne linki
Publikacje ogólne
- Gorno-Tempini ML, Price CJ. Identification of famous faces and buildings: a functional neuroimaging study of semantically unique items. Brain. 2001 Oct;124(Pt 10):2087-97. doi: 10.1093/brain/124.10.2087.
- Gainotti G. Is the difference between right and left ATLs due to the distinction between general and social cognition or between verbal and non-verbal representations? Neurosci Biobehav Rev. 2015 Apr;51:296-312. doi: 10.1016/j.neubiorev.2015.02.004. Epub 2015 Feb 16.
- Chan D, Anderson V, Pijnenburg Y, Whitwell J, Barnes J, Scahill R, Stevens JM, Barkhof F, Scheltens P, Rossor MN, Fox NC. The clinical profile of right temporal lobe atrophy. Brain. 2009 May;132(Pt 5):1287-98. doi: 10.1093/brain/awp037. Epub 2009 Mar 18.
- Bruce V, Young A. Understanding face recognition. Br J Psychol. 1986 Aug;77 ( Pt 3):305-27. doi: 10.1111/j.2044-8295.1986.tb02199.x.
- Brambati SM, Benoit S, Monetta L, Belleville S, Joubert S. The role of the left anterior temporal lobe in the semantic processing of famous faces. Neuroimage. 2010 Nov 1;53(2):674-81. doi: 10.1016/j.neuroimage.2010.06.045. Epub 2010 Jun 30.
- Blank H, Wieland N, von Kriegstein K. Person recognition and the brain: merging evidence from patients and healthy individuals. Neurosci Biobehav Rev. 2014 Nov;47:717-34. doi: 10.1016/j.neubiorev.2014.10.022.
- Bizzozero I, Lucchelli F, Saetti MC, Spinnler H. "Whose face is this?": Italian norms of naming celebrities. Neurol Sci. 2007 Dec;28(6):315-22. doi: 10.1007/s10072-007-0845-6. Epub 2008 Jan 4.
- Binney RJ, Henry ML, Babiak M, Pressman PS, Santos-Santos MA, Narvid J, Mandelli ML, Strain PJ, Miller BL, Rankin KP, Rosen HJ, Gorno-Tempini ML. Reading words and other people: A comparison of exception word, familiar face and affect processing in the left and right temporal variants of primary progressive aphasia. Cortex. 2016 Sep;82:147-163. doi: 10.1016/j.cortex.2016.05.014. Epub 2016 Jun 9.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- I-FACE CTSM162-25
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Individual participant data (IPD) will not be shared because the data include sensitive clinical and neuropsychological information, and sharing could compromise participant confidentiality. The informed consent and ethics approval do not provide for public sharing of IPD. De-identified data may be considered for sharing upon reasonable request, subject to approval by the study investigators and applicable privacy and ethical requirements
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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