Italian Validation of the Beaumont Behavioural Inventory (BBI) (BBI)

October 20, 2021 updated by: Istituti Clinici Scientifici Maugeri SpA

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

190

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milano, Italy, 20138
        • ICS Maugeri

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subject with amyotrophic lateral sclerosis

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients
patients with amyotrophic lateral sclerosis
Behavioral: BBI
administration of psychometric test
Healthy control
healthy control participants
Behavioral: BBI
administration of psychometric test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beaumont Behavioural Inventory
Time Frame: 2 years
Psychometrics
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituti Clinici Scientifici Maugeri SpA

Collaborators

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 17, 2019

Primary Completion (ACTUAL)

September 30, 2020

Study Completion (ACTUAL)

November 30, 2020

Study Registration Dates

First Submitted

June 18, 2020

First Submitted That Met QC Criteria

June 18, 2020

First Posted (ACTUAL)

June 19, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 22, 2021

Last Update Submitted That Met QC Criteria

October 20, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE 2320

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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