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Recruiting NCT04008329

A Registered Cohort Study on Amyotrophic Lateral Sclerosis

Observational Amyotrophic Lateral Sclerosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Amyotrophic Lateral Sclerosis. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Amyotrophic lateral sclerosis (ALS) is a kind of motor neuron degeneration disorder without effective therapy. This registered cohort study will provide further insights into the clinical course of ALS, and investigate disease-relative risk factors and the genetic background of Chinese ALS patients.

Detailed description

Amyotrophic lateral sclerosis (ALS) is the most common form of motor neuron disease (MND), which is characterized with highly clinical heterogeneity and no effective treatment is available now. The purpose of this registered cohort is to observe the natural history of ALS patients in China, and then identify some factors correlated with disease progression. Besides, ALS-related gene mutations will be screened and explore novel disease causing gene as well.

Primary outcome measures

  • Age at death [Time frame: 10 years]
  • Age of endotracheal intubation or tracheotomy [Time frame: 10 years]

Eligibility criteria

Inclusion criteria

  • Amyotrophic Lateral Sclerosis patients fulfilling the El Escorial criteria (including definite, probable and possible)
  • Progressive muscular atrophy
  • Primary lateral sclerosis
  • Progressive bulbar palsy

Exclusion criteria

  • History of serious head trauma or neuropsychiatric disease
  • Decline to participate

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Department of Neurology, First Affiliated Hospital of Fujian Medical University — Fuzhou

Publications

  • Liu K, Guo Q, Ding Y, Luo L, Huang J, Zhang Q. Alterations in nasal microbiota of patients with amyotrophic lateral sclerosis. Chin Med J (Engl). 2024 Jan 20;137(2):162-171. doi: 10.1097/CM9.0000000000002701. Epub 2023 Jul 21. PMID 37482646

Identifiers

NCT: NCT04008329 · MRCTA,ECFAH of FMU [2019]191

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗