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

NCT05407428 | Completed

• 1 other identifier: NL/ALS/2022-2
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  18 months

Secondary Outcomes (1)

• Using the retrieved data of collected NeuraLight oculometric measures for calibration of prediction models of ALSFRS-R clinical endpoint

  18 months

Interventions

NeuraLight software-based platform OTHER

NeuraLight is an investigational software-based platform that is used for assessment and evaluation of neurological conditions including ALS patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

About 45 ALS patients, ages 18-75 years with familial or sporadic ALS, according to the Gold Coast Criteria, who are recruited and participating in the PrimeC drug study (NCT05357950)

You may qualify if:

• Able to comprehend and willing to sign an informed consent form (ICF)
• Males or females between the ages of 18 and 75 years of age, inclusive
• Diagnosis of familial or sporadic ALS (defined as meeting the laboratory-supported probable, probable, or definite criteria for a diagnosis of ALS according to the Gold Coast criteria)
• Disease duration after first symptom (muscle weakness) less than 30 months prior to screening
• Pre-enrollment ALSFRS-R slope from disease onset ≥ 0.3 points per month
• ALSFRS-R at screening ≥ 25
• Item 3 (swallowing) in ALSFRS-R ≥ 3
• Subjects may be treated in parallel with Riluzole and/or Edaravone and/or Sodium Phenylbutyrate; 30 days of stable use prior to enrollment is required
• Upright slow vital capacity (SVC) ≥ 60% of predicted for age, height, weight and sex at screening according to the GLI-2012
• \< BMI \< 30
• A caregiver (if one is needed)
• Female subjects must be post-menopausal (≥ 1 year) OR sterilized, OR if of childbearing potential (i.e., females who have had their first period unless they are anatomically or physiologically incapable to become pregnant), must have a negative pregnancy test, and agree to use contraceptive drugs or devices (e.g., diaphragm plus spermicide, or oral contraceptives) for the duration of the study and 10 weeks after the last treatment dose AND require male partners to use a condom during sexual intercourse

You may not qualify if:

• A past history of adverse reaction/hypersensitivity to either NSAIDs, celecoxib or fluoroquinolones, ciprofloxacin
• Any known clinically significant abnormal gastric mucosal erosion, ulcer or tumor or/and GI disorder and/or bariatric surgery Known history of clinically significant impairment of renal function (creatinine ≥ 1.5)
• Known or suspected symptomatic congestive heart and/or coronary heart disease, previous history of myocardial infarction, uncontrolled arterial hypertension, or rhythm abnormalities requiring permanent treatment
• Known history of QT/QTc prolongation, Torsade de pointes (TdP) (e.g. heart failure, hypokalemia, family history of Long QT syndrome) and the use of concomitant medications that prolong the QT/QTc interval
• Known or suspected diagnosis or family history of epilepsy in first degree relatives
• Known predisposition to tendinitis
• Tracheostomy or percutaneous gastrostomy use
• Presence at screening of any medically significant cardiac, pulmonary, musculoskeletal, or psychiatric illness that might interfere with the subject's ability to comply with study procedures or that might confound the interpretation of clinical safety data, including, but not limited to:
• Mean systolic blood pressure \>160 mm Hg and/or mean diastolic blood pressure \>100 mm Hg (measurements taken after a few minutes rest) that persist on 3 successive measurements taken at least 2 minutes apart
• NYHA Class II or greater congestive heart failure
• Chronic obstructive pulmonary disease or asthma requiring daily use of bronchodilator medications
• Poorly controlled or brittle diabetes mellitus
• Cognitive impairment, related to ALS or otherwise, sufficient to impair subject's ability to understand and/or comply with study procedures and provide informed consent
• Subject who is treated with chronic aspirin or NSAIDs and is at risk if stopped. Clopidogrel is allowed and can replace Aspirin.
• Any contraindication for ciprofloxacin and celecoxib according to the current prescribing information.

Sponsors & Collaborators

• NeuraLight: lead

Study Sites (1)

Sourasky medical center

Tel Aviv, 6423906, Israel

Location

Related Publications (2)

• Kang BH, Kim JI, Lim YM, Kim KK. Abnormal Oculomotor Functions in Amyotrophic Lateral Sclerosis. J Clin Neurol. 2018 Oct;14(4):464-471. doi: 10.3988/jcn.2018.14.4.464. Epub 2018 Jun 27.

  PMID: 30198218 BACKGROUND

• Guo X, Liu X, Ye S, Liu X, Yang X, Fan D. Eye Movement Abnormalities in Amyotrophic Lateral Sclerosis. Brain Sci. 2022 Apr 11;12(4):489. doi: 10.3390/brainsci12040489.

  PMID: 35448020 RESULT

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Vivian Drory, MD

  Sackler Faculty of Medicine, Tel Aviv University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2022
• First Posted: June 7, 2022
• Study Start: May 31, 2022
• Primary Completion: October 28, 2024
• Study Completion: October 28, 2024
• Last Updated: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)