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

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ClinicalTrials.gov Identifier: NCT04440644
Recruitment Status : Recruiting
First Posted : June 19, 2020
Last Update Posted : June 19, 2020
Sponsor:
Collaborator:
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Amyotrophic Lateral Sclerosis Behavioral: BBI

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Validazione Italiana Dello Strumento BBI (Beaumont Behavioural Inventory) Per la Valutazione Delle Alterazioni Comportamentali Nel Paziente Affetto da Malattia Del Motoneurone
Actual Study Start Date : September 17, 2019
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020


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




Primary Outcome Measures :
  1. Beaumont Behavioural Inventory [ Time Frame: 2 years ]
    Psychometrics



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subject with amyotrophic lateral sclerosis
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04440644


Contacts
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Contact: Gabriele Mora, MD +390250725260 gabriele.mora@icsmaugeri.it
Contact: Debora Pain, PsyD +390250725221 debora.pain@icsmaugeri.it

Locations
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Italy
ICS Maugeri Recruiting
Milano, Italy, 20138
Contact: Gabriele Mora, MD    +390250725260    gabriele.mora@icsmaugeri.it   
Sponsors and Collaborators
Istituti Clinici Scientifici Maugeri SpA
Azienda Ospedaliera Città della Salute e della Scienza di Torino
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Responsible Party: Istituti Clinici Scientifici Maugeri SpA
ClinicalTrials.gov Identifier: NCT04440644    
Other Study ID Numbers: CE 2320
First Posted: June 19, 2020    Key Record Dates
Last Update Posted: June 19, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Istituti Clinici Scientifici Maugeri SpA:
ALS; frontotemporal degeneration; behavioural changes.
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases