Advances in Neuropsychological Diagnostics

Recruiting

• Conditions: Cognitive Impairment; Dementia; Psychiatric Disorder
• Interventions: Behavioral: Neuropsychological instruments

• Registration Number: NCT05794061
• Lead Sponsor: Istituto Auxologico Italiano

Brief Summary

This project is aimed at advancing neuropsychological diagnostics, enriching and modernizing the panorama of both clinical and forensic psychometric testing. The rapid socio-demographic changes, the developments of neuropsychological semiotics and nosography, as well as the growing applicative specialization of neuropsychological assessment make it necessary to introduce further tools to satisfy the diagnostic requests in clinical contexts and more recently in the forensic field (i.e., tests to be administered remotely; bedside screeners; domain-specific in-depth tests; tools for assessing testamentary capacity).

Specifically, the present study aims to: a) develop, calibrate and evaluate the psychometric properties of I and II level clinical and/or forensic neuropsychological tests evaluating instrumental and non-instrumental functions in a sample of neurologically healthy individuals representative of the Italian population ; b) evaluate the cross-sectional and longitudinal clinical usability of the aforementioned tests in clinical samples (patients with neurological and neuropsychiatric pathologies of different etiology).

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-11
• Study First Submitted: 2023-02-24
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-20
• Last Update Submitted: 2023-03-20
• Study First Posted: 2023-03-31
• Last Update Posted: 2023-03-31
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Clinical populations: clinical diagnosis of either neurological (e.g., vascular and degenerative aetiologies) or psychiatric disorders.
• Healthy controls: not applicable

Exclusion Criteria

• Clinical populations:

  1. Clinical diagnosis not of interest;
  2. Severe general medical conditions;
  3. Uncorrected vision/hearing deficits.

• Healthy controls:

  1. Presence of brain disorders;
  2. Severe general medical conditions;
  3. Uncorrected vision/hearing deficits.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	Neuropsychological instruments	Patients with brain disorders
Healthy controls	Neuropsychological instruments	Neurologically Healthy Controls

Primary Outcome Measures

Name	Time	Method
Change from baseline in Brief Assessment of Social Skills-Dementia (BASS-D)	At baseline (i.e., at the enrollment; all participants); after 1 month (for test-retest analyses in neurologically healthy individuals); after 6, 12, and 18 months in participants with neurodegenerative disorders	A screening test of social cognition in neurodegeneration
Change from baseline in Verbal Reasoning Test (VRT-A) - Absurdity sub-test	At baseline (i.e., at the enrollment; all participants); after 1 month (for test-retest analyses in neurologically healthy individuals); after 6, 12, and 18 months in participants with neurodegenerative disorders	A test of verbal reasoning
Change from baseline in Picture Interpretation Test (PIT)	At baseline (i.e., at the enrollment; all participants); after 1 month (for test-retest analyses in neurologically healthy individuals); after 6, 12, and 18 months in participants with neurodegenerative disorders	A test of executive functions
Change from baseline in Brief Executive Language Screen (BELS)	At baseline (i.e., at the enrollment; all participants); after 1 month (for test-retest analyses in neurologically healthy individuals); after 6, 12, and 18 months in participants with neurodegenerative disorders	A language test
Change from baseline in Testament Definition Scale (TDS)	At baseline (i.e., at the enrollment; all participants); after 1 month (for test-retest analyses in neurologically healthy individuals); after 6, 12, and 18 months in participants with neurodegenerative disorders	A scale to assess testament representation
Change from baseline in Telephone Interview for Cognitive Status (TICS)	At baseline (i.e., at the enrollment; all participants); after 1 month (for test-retest analyses in neurologically healthy individuals); after 6, 12, and 18 months in participants with neurodegenerative disorders	A telephone-based screening test of global cognitive efficiency
Change from baseline in Telephone-based Mini-Mental State Examination (I-TEL-MMSE)	At baseline (i.e., at the enrollment; all participants); after 1 month (for test-retest analyses in neurologically healthy individuals); after 6, 12, and 18 months in participants with neurodegenerative disorders	A telephone-based screening test of global cognitive efficiency
Change from baseline in Telephone-based Frontal Assessment Battery (t-FAB)	At baseline (i.e., at the enrollment; all participants); after 1 month (for test-retest analyses in neurologically healthy individuals); after 6, 12, and 18 months in participants with neurodegenerative disorders	A telephone-based screening test of executive functions
Change from baseline in Development Telephone Language Screener (TLS)	At baseline (i.e., at the enrollment; all participants); after 1 month (for test-retest analyses in neurologically healthy individuals); after 6, 12, and 18 months in participants with neurodegenerative disorders	A new telephone-based test to asses linguistic functions
Change from baseline in Bamberg Dementia Screening Test (BDST)	At baseline (i.e., at the enrollment; all participants); after 1 month (for test-retest analyses in neurologically healthy individuals); after 6, 12, and 18 months in participants with neurodegenerative disorders	A test of global cognitive efficiency
Change from baseline in Testamentary Capacity Assessment Tool (TCAT)	At baseline (i.e., at the enrollment; all participants); after 1 month (for test-retest analyses in neurologically healthy individuals); after 6, 12, and 18 months in participants with neurodegenerative disorders	A test to assess cognitive functions (i.e., memory, executive functions, social cognition, and numerical abilities) at the base of testamentary capacity
Change from baseline in Development of the Bizzare Pictures Test (BPT)	At baseline (i.e., at the enrollment; all participants); after 1 month (for test-retest analyses in neurologically healthy individuals); after 6, 12, and 18 months in participants with neurodegenerative disorders	A new visual test to assess reasoning abilities
Change from baseline in Telephone-based Global Examination of Mental State (tele-GEMS)	At baseline (i.e., at the enrollment; all participants); after 1 month (for test-retest analyses in neurologically healthy individuals); after 6, 12, and 18 months in participants with neurodegenerative disorders	A telephone-based screening test of global cognitive efficiency
Change from baseline in Telephone-based Amyotrophic Lateral Sclerosis Cognitive Behavioural Screen (ALS-CBS™-PhV	At baseline (i.e., at the enrollment; all participants); after 1 month (for test-retest analyses in neurologically healthy individuals); after 6, 12, and 18 months in participants with neurodegenerative disorders	A telephone-based screening test for cognitive functions in ALS

Trial Locations

Locations (1)

Istituto Auxologico Italiano IRCCS; 🇮🇹 Milan, Lombardia, Italy