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A Prospective Study to Evaluate the Correlation Between Oculometric Measurements and Clinical Endpoints in ALS Patients

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:
An Prospective Study in a Cohort of Amyotrophic Lateral Sclerosis (ALS) Patients Participating in a Phase IIb Drug Study (NCT05357950) to Evaluate the Correlation Between Oculometric Measurements and ALS Functional Rating Scale (ALSFRS-R)

Clinical Trial Summary

This is a prospective study in a cohort of about 45 patients with ALS participating in the Neurosense PrimeC drug study (NCT05357950). This study aims to evaluate the correlation between oculometric measures and clinical endpoints. Subjects will be evaluated every 2 months during a time period of 18 months. The evaluations will include ALSFRS-R examination, as well as an oculometric evaluation for eye movements.

Clinical Trial Description

This is an observational prospective study in a cohort of about 45 patients with ALS participating in the Neurosense PrimeC drug study (NCT05357950), which is a Phase IIb, Randomized, Prospective, Double-Blind, Placebo-Controlled Study, to Evaluate Safety, Tolerability and Efficacy of PrimeC in Subjects with ALS. The subjects are males or females with familial or sporadic ALS of no more than 30 months disease duration, who meet the inclusion criteria of the PrimeC drug study, provide a signed an Informed consent and are willing and able to comply with study's procedures including follow-up visits. This study is designed to evaluate the correlation between oculometric measures and the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R). Subjects will be evaluated every 2 months during a time period of 18 months. The evaluations will include an ALSFRS-R examination by a certified neurologist and other tests. In addition, all patients will undergo a NeuraLight session for oculometric evaluation along with eye-tracking recordings. All assessments will be performed during a clinic visit unless authorized to be conducted remotely. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05407428
Study type Observational
Source NeuraLight
Contact Eitan Raveh, PhD
Phone +972-58-6277947
Email eitan@neuralight.ai
Status Recruiting
Phase
Start date May 31, 2022
Completion date November 30, 2024
View Details
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