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.
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 Type
OBSERVATIONAL
Enrollment
45
NeuraLight is an investigational software-based platform that is used for assessment and evaluation of neurological conditions including ALS patients
Sourasky medical center
Tel Aviv, Israel
Correlation between ALSFRS-R score and its parts with NeuraLight oculometric measurements
The correlation between ALSFRS-R score and its parts with NeuraLight oculometric measurements (R-Square\>0.5, p\<0.05) according to the measured ALS functional rating scale - revised (ALSFRS-R) at every visit
Time frame: 18 months
Feasibility of using NeuraLight system to capture oculometric measures in a cohort of ALS patients
Capturing \>50 different oculometric measures in \>95% of a cohort of 45 patients
Time frame: 18 months
Comparison of NeuraLight extracted oculometric measures with a validated eye-tracking system
Relative root mean square error (RMSE) of NeuraLight's extracted oculometric measures compared with retrieved measurements from a validated eye tracking system \<0.1
Time frame: 18 months
Using the retrieved data of collected NeuraLight oculometric measures for calibration of prediction models of ALSFRS-R clinical endpoint
Optimization of a feature selection model (Fisher's Linear Discriminant Analysis (LDA)) on NeuraLight oculometric measures used for a logistic regression model of ALSFRS-R with a relative root mean square error (RMSE) of \<0.1
Time frame: 18 months
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