Creation of a Clinical Database for the Study of Phenotypic Variability in Motor Neuron Diseases
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, Motor Neuron Disease. Basic parameters: from 18 years · 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
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Creazione di un Database Clinico Per lo Studio Della variabilità Fenotipica Nella Malattia Del Motoneurone
Overview
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.
Primary outcome measures
- no. of patients with classic ALS [Time frame: baseline (at diagnosis), at 1 year]
- no. of patients with bulbar ALS [Time frame: baseline (at diagnosis), at 1 year]
- no. of patients with LMN phenotypes (flail arm, flail leg, PMA) [Time frame: baseline (at diagnosis), at 1 year]
- no. of patients with UMN phenotypes (pyramidal ALS, PLS) [Time frame: baseline (at diagnosis), at 1 year]
Eligibility criteria
Inclusion criteria
- diagnosis of ALS or other motor neuron disease
Exclusion criteria
- refusal to participate to the study
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
Italy · 1 center
- Ospedale San Luca — Milan
Identifiers
NCT: NCT06318585 · 23C306