Study Purpose:
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 Status:
Not recruiting
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Observational
Type of Intervention:
N/A
Intervention Name:
N/A
Placebo:
N/A
Phase:
N/A
Study Chair(s)/Principal Investigator(s):
N/A
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Study Sponsor:
Istituti Clinici Scientifici Maugeri SpA
Estimated Enrollment:
190
Estimated Study Start Date:
09 / 17 / 2019
Estimated Study Completion Date:
11 / 30 / 2020
Posting Last Modified Date:
10 / 22 / 2021
Date Study Added to neals.org:
06 / 19 / 2020
Minimum Age:
N/A
Maximum Age:
N/A
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
ICS Maugeri
Milano 20138
Italy