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NCT04440644 Clinical Trial

Italian Validation of the Beaumont Behavioural Inventory (BBI)

Amyotrophic Lateral Sclerosis Clinical Trial

— BBI  

Official title:
Validazione Italiana Dello Strumento BBI (Beaumont Behavioural Inventory) Per la Valutazione Delle Alterazioni Comportamentali Nel Paziente Affetto da Malattia Del Motoneurone

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04440644
Other study ID # CE 2320
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 17, 2019
Est. completion date November 30, 2020

Study information
Verified date October 2021
Source Istituti Clinici Scientifici Maugeri SpA
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Up to 50% of patients affected with amyotrophic lateral sclerosis (ALS) can show behavioral dysfunctions within the spectrum of frontotemporal degenerations (FTD) - namely, apathy, disinhibition, loss of sympathy/empathy, perseverative and stereotyped behaviours, dietary changes [Strong et al., 2017]. The Beaumont Behavioural Inventory (BBI) [Elamin et al., 2017] is a questionnaire designed for detecting FTD-spectrum behavioural changes in ALS patients. The present study aims at both validating the BBI in an Italian ALS population and determining normative cut-off values of the instrument.

Recruitment information / eligibility
Status Completed
Enrollment 190
Est. completion date November 30, 2020
Est. primary completion date September 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - possible, probable or definite ALS according to El Escorial revised criteria Exclusion Criteria: - Any other clinically significant cardiovascular, gastrointestinal, hepatic, renal, neurological or psychiatric disorder or any other major concurrent illness that in the opinion of the investigator could interfere with the interpretation of the study results

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• BBI
administration of psychometric test

Locations
Country Name City State
Italy ICS Maugeri Milano

Sponsors (2)
Lead Sponsor Collaborator
Istituti Clinici Scientifici Maugeri SpA Azienda Ospedaliera Città della Salute e della Scienza di Torino

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Iazzolino B, Pain D, Laura P, Aiello EN, Gallucci M, Radici A, Palumbo F, Canosa A, Moglia C, Calvo A, Mora G, Chiò A. Italian adaptation of the Beaumont Behavioral Inventory (BBI): psychometric properties and clinical usability. Amyotroph Lateral Scler F — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Beaumont Behavioural Inventory Psychometrics 2 years
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