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临床试验/NCT04440644
NCT04440644已完成不适用

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

Istituti Clinici Scientifici Maugeri SpA1 个研究点 分布在 1 个国家目标入组 190 人开始时间: 2019年9月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
190
试验地点
1
主要终点
Beaumont Behavioural Inventory

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

  • possible, probable or definite ALS according to El Escorial revised criteria

排除标准

  • 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

结局指标

主要结局

Beaumont Behavioural Inventory

时间窗: 2 years

Psychometrics

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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