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Italian Validation of the Beaumont Behavioural Inventory (BBI)

NCT ID: NCT04440644

Last Updated: 2021-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

190 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-17

Study Completion Date

2020-11-30

Brief Summary

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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

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Conditions

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Amyotrophic Lateral Sclerosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients

patients with amyotrophic lateral sclerosis

BBI

Intervention Type BEHAVIORAL

administration of psychometric test

Healthy control

healthy control participants

BBI

Intervention Type BEHAVIORAL

administration of psychometric test

Interventions

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BBI

administration of psychometric test

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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A.O.U. Città della Salute e della Scienza

OTHER

Sponsor Role collaborator

Istituti Clinici Scientifici Maugeri SpA

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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ICS Maugeri

Milan, , Italy

Site Status

Countries

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Italy

References

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Iazzolino B, Pain D, Laura P, Aiello EN, Gallucci M, Radici A, Palumbo F, Canosa A, Moglia C, Calvo A, Mora G, Chio A. Italian adaptation of the Beaumont Behavioral Inventory (BBI): psychometric properties and clinical usability. Amyotroph Lateral Scler Frontotemporal Degener. 2022 Feb;23(1-2):81-86. doi: 10.1080/21678421.2021.1946085. Epub 2021 Jul 19.

Reference Type RESULT
PMID: 34279169 (View on PubMed)

Other Identifiers

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CE 2320

Identifier Type: -

Identifier Source: org_study_id