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Italian Validation of the Beaumont Behavioural Inventory (BBI)

I

Istituti Clinici Scientifici Maugeri SpA

Status

Completed

Conditions

Amyotrophic Lateral Sclerosis

Treatments

Behavioral: BBI

Study type

Observational

Funder types

Other

Identifiers

NCT04440644
CE 2320

Details and patient eligibility

About

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.

Enrollment

190 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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

Trial design

190 participants in 2 patient groups

Patients
Description:
patients with amyotrophic lateral sclerosis
Treatment:
Behavioral: BBI
Healthy control
Description:
healthy control participants
Treatment:
Behavioral: BBI

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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