Registration Study of Amyotrophic Lateral Sclerosis (ALS) in Mainland China

Study Overview
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Brief Summary
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A multi-center registration study of natural history and clinical characteristics of ALS in mainland China

Detailed Description
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Amyotrophic lateral sclerosis (ALS) is a rapidly progressive neurodegenerative disease of unknown etiology that is currently incurable. This study is a national multi-center registration study. The study collects general information of ALS patients including medical history, disease characteristics, clinical treatment data, and patient information for different visits in different centers. The aim of the study is: a) describe the distribution of ALS in mainland China(explore the differences in the number of ALS at different times, different regions, and different populations) and further find the reasons that affect the distribution of ALS, b) study the development of ALS in mainland China and the corresponding changes in the characteristics of the disease, c) explore factors that influence the prognosis of ALS.

Official Title
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Registration Study of Natural History and Clinical Characteristics of Amyotrophic Lateral Sclerosis (ALS) in Mainland China

Conditions
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Amyotrophic Lateral Sclerosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of laboratory-supported probable, probable, or definite ALS according to EI Escorial diagnostic criteria Age: 18-70 years Exclusion Criteria: Refuse to cooperate or reject the informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effective Survival | The length of time from the date of diagnosis to patient death or tracheotomy or ventilator-assisted breathing. | through study completion, an average of 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | The length of time from the date of diagnosis to patient death due to any cause or the last confirmed survival. | through study completion, an average of 3 month | 
| Rate of disease progression | The slope of decline of the ALS Functional Rating Scale-Revised (ALSFRS-R) score from the diagnosis time to the follow-up time. ALSFRS-R values from 0 to 48 and it implies better outcome when it is higher. | through study completion, an average of 3 month | 
| Rate of Weight decline | The slope of decline of weight | through study completion, an average of 3 month | 
| Rate of BMI decline | The slope of decline of BMI | through study completion, an average of 3 month | 
| Rate of Forced Vital Capacity (FVC) | The slope of decline of Forced Vital Capacity (FVC) to assess the respiratory function. | through study completion, an average of 3 month |