Creazione di un Database Clinico Per lo Studio Della variabilità Fenotipica Nella Malattia Del Motoneurone
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- no. of patients with bulbar ALS
研究概览
简要总结
Study Description: Characterization of Motor Neuron Disease Phenotypes
The goal of this observational study is to understand the clinical presentation of motor neuron disease (MND) in patients attending the Neurology Department of the Istituto Auxologico Italiano. The main questions it aims to answer are:
- What are the specific clinical phenotypes associated with MND?
- How can these phenotypes contribute to a better understanding of the disease's underlying mechanisms and improve prognostic accuracy?
Participants will undergo:
- Clinical evaluation using validated scales
- Neurophysiological and neuroradiological instrumental assessment
- Neuropsychological evaluation
- Collection of biological materials for genetic screening and biomarker assessment, if necessary.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of ALS or other motor neuron disease
排除标准
- •refusal to participate to the study
结局指标
主要结局
no. of patients with bulbar ALS
时间窗: baseline (at diagnosis), at 1 year
no. of patients with bulbar ALS
no. of patients with LMN phenotypes (flail arm, flail leg, PMA)
时间窗: baseline (at diagnosis), at 1 year
no. of patients with LMN phenotypes (flail arm, flail leg, PMA)
no. of patients with classic ALS
时间窗: baseline (at diagnosis), at 1 year
no. of patients with classic ALS
no. of patients with UMN phenotypes (pyramidal ALS, PLS)
时间窗: baseline (at diagnosis), at 1 year
no. of patients with UMN phenotypes (pyramidal ALS, PLS)
次要结局
未报告次要终点