Creation of a Clinical Database for the Study of Phenotypic Variability in Motor Neuron Diseases

Recruiting

• Conditions: Amyotrophic Lateral Sclerosis; Motor Neuron Disease

• Registration Number: NCT06318585
• Lead Sponsor: Istituto Auxologico Italiano

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-03
• Status Verified: 2024-03
• Study First Submitted: 2024-03-08
• Study First Submitted QC: 2024-03-15
• Last Update Submitted: 2024-03-15
• Study First Posted: 2024-03-19
• Last Update Posted: 2024-03-19
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• diagnosis of ALS or other motor neuron disease

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Exclusion Criteria

• refusal to participate to the study

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
no. of patients with bulbar ALS	baseline (at diagnosis), at 1 year	no. of patients with bulbar ALS
no. of patients with classic ALS	baseline (at diagnosis), at 1 year	no. of patients with classic ALS
no. of patients with LMN phenotypes (flail arm, flail leg, PMA)	baseline (at diagnosis), at 1 year	no. of patients with LMN phenotypes (flail arm, flail leg, PMA)
no. of patients with UMN phenotypes (pyramidal ALS, PLS)	baseline (at diagnosis), at 1 year	no. of patients with UMN phenotypes (pyramidal ALS, PLS)

Trial Locations

Locations (1)

Ospedale San Luca; 🇮🇹 Milano, MI, Italy