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Italian Validation of the Beaumont Behavioural Inventory (BBI)

Completed
Conditions
Amyotrophic Lateral Sclerosis
Interventions
Behavioral: BBI
Registration Number
NCT04440644
Lead Sponsor
Istituti Clinici Scientifici Maugeri SpA
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
190
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

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Healthy controlBBIhealthy control participants
PatientsBBIpatients with amyotrophic lateral sclerosis
Primary Outcome Measures
NameTimeMethod
Beaumont Behavioural Inventory2 years

Psychometrics

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

ICS Maugeri

🇮🇹

Milano, Italy

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