Creation of a Clinical Database for the Study of Phenotypic Variability in Motor Neuron Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIstituto Auxologico Italiano
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
diagnosis of ALS or other motor neuron disease
Disqualifiers
refusal to participate to the study
Trial population
Consecutive cohort of patients from a tertiary Italian ALS Centre
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
no. of patients with classic ALS
no. of patients with classic ALS
Time frame
baseline (at diagnosis), at 1 year2
no. of patients with bulbar ALS
no. of patients with bulbar ALS
Time frame
baseline (at diagnosis), at 1 year3
no. of patients with LMN phenotypes (flail arm, flail leg, PMA)
no. of patients with LMN phenotypes (flail arm, flail leg, PMA)
Time frame
baseline (at diagnosis), at 1 year4
no. of patients with UMN phenotypes (pyramidal ALS, PLS)
no. of patients with UMN phenotypes (pyramidal ALS, PLS)
Time frame
baseline (at diagnosis), at 1 yearSponsors and contacts
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Source ClinicalTrials.gov