Skip to main content
Clinical Trials/NCT06318585
NCT06318585
Recruiting
N/A

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

Istituto Auxologico Italiano1 site in 1 country200 target enrollmentApril 3, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Amyotrophic Lateral Sclerosis
Sponsor
Istituto Auxologico Italiano
Enrollment
200
Locations
1
Primary Endpoint
no. of patients with bulbar ALS
Status
Recruiting
Last Updated
12 months ago

Overview

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.
Registry
clinicaltrials.gov
Start Date
April 3, 2023
End Date
December 31, 2026
Last Updated
12 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • diagnosis of ALS or other motor neuron disease

Exclusion Criteria

  • refusal to participate to the study

Outcomes

Primary Outcomes

no. of patients with bulbar ALS

Time Frame: baseline (at diagnosis), at 1 year

no. of patients with bulbar ALS

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)

no. of patients with classic ALS

Time Frame: baseline (at diagnosis), at 1 year

no. of patients with classic ALS

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)

Study Sites (1)

Loading locations...

Similar Trials