Creation of a Clinical Database for the Study of Phenotypic Variability in Motor Neuron Diseases (ALS-PHENO)

March 15, 2024 updated by: Istituto Auxologico Italiano

Creazione di un Database Clinico Per lo Studio Della variabilità Fenotipica Nella Malattia Del Motoneurone

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • MI
      • Milano, MI, Italy, 20149
        • Recruiting
        • Ospedale San Luca
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Consecutive cohort of patients from a tertiary Italian ALS Centre

Description

Inclusion Criteria:

  • diagnosis of ALS or other motor neuron disease

Exclusion Criteria:

  • refusal to participate to the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
no. of patients with classic ALS
Time Frame: baseline (at diagnosis), at 1 year
no. of patients with classic ALS
baseline (at diagnosis), at 1 year
no. of patients with bulbar ALS
Time Frame: baseline (at diagnosis), at 1 year
no. of patients with bulbar ALS
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 LMN phenotypes (flail arm, flail leg, PMA)
baseline (at diagnosis), at 1 year
no. of patients with UMN phenotypes (pyramidal ALS, PLS)
Time Frame: baseline (at diagnosis), at 1 year
no. of patients with UMN phenotypes (pyramidal ALS, PLS)
baseline (at diagnosis), at 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Auxologico Italiano

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 8, 2024

First Submitted That Met QC Criteria

March 15, 2024

First Posted (Actual)

March 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 15, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23C306

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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