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
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
- 是
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
研究点 (1)
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