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Development and Validation of a Novel Functional Eye-Tracking Software Application for Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT05061953
Recruitment Status : Recruiting
First Posted : September 30, 2021
Last Update Posted : December 16, 2022
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Innodem Neurosciences

Brief Summary:

This study aims to develop and validate a sensitive and non-invasive eye-tracking software application.

This study will obtain participant responses to brief cognitive tests designed to evaluate several key functions known to be affected by MS and non-invasive eye movement measurements in response to visually presented stimuli during specifically designed eye-tracking tests. The study data will be used to develop machine learning algorithms and validate a software application intended to track the progressive component of multiple sclerosis and associated cognitive changes.


Condition or disease Intervention/treatment
Multiple Sclerosis Device: Eye-Tracking

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Study Type : Observational
Estimated Enrollment : 162 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development and Validation of a Novel Functional Eye-Tracking Software Application for Multiple Sclerosis
Actual Study Start Date : October 18, 2021
Estimated Primary Completion Date : October 18, 2027
Estimated Study Completion Date : October 18, 2027

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
EDSS 0-2.0
Confirmed diagnosis of MS with an EDSS score between 0 and 2.0.
Device: Eye-Tracking
Eye-tracking technology and algorithms used to successfully capture and track eye movements using an electronic tablet and the embedded camera of the device.

EDSS 2.5-4.0
Confirmed diagnosis of MS with an EDSS score between 2.5 and 4.0.
Device: Eye-Tracking
Eye-tracking technology and algorithms used to successfully capture and track eye movements using an electronic tablet and the embedded camera of the device.

EDSS 4.5-6.0
Confirmed diagnosis of MS with an EDSS score between 4.5 and 6.0.
Device: Eye-Tracking
Eye-tracking technology and algorithms used to successfully capture and track eye movements using an electronic tablet and the embedded camera of the device.

EDSS 6.5-8.0
Confirmed diagnosis of MS with an EDSS score between 6.5 and 8.0.
Device: Eye-Tracking
Eye-tracking technology and algorithms used to successfully capture and track eye movements using an electronic tablet and the embedded camera of the device.

Healthy Control
Participant with no evidence or history of significant neurodegenerative disorder affecting brain function.
Device: Eye-Tracking
Eye-tracking technology and algorithms used to successfully capture and track eye movements using an electronic tablet and the embedded camera of the device.




Primary Outcome Measures :
  1. Change from Baseline in Symbol Digit Modalities Test (SDMT) score at Month 48 [ Time Frame: Baseline and Month 48 ]
    The SDMT is used to assess divided attention, visual scanning, tracking and motor speed. Using a reference key, the examinee has 90 seconds to pair specific numbers with given geometric figures. Scoring involves summing the number of correct substitutions within the 90 second interval.


Secondary Outcome Measures :
  1. Change from Baseline in the Expanded Disability Status Scale (EDSS) score at Month 48 [ Time Frame: Baseline and Month 48 ]
    The Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. It is widely used in clinical trials and in the assessment of people with MS. The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability. Scoring is based on an examination by a neurologist.

  2. Change from Baseline in the Brief International Cognitive Assessment for MS (BICAMS) scores at Month 48 [ Time Frame: Baseline and Month 48 ]
    The BICAMS is a battery of tests recommended by multiple sclerosis (MS) experts to monitor MS-related cognitive impairment. It includes the Symbol Digit Modalities Test (SDMT), the California Verbal Learning Test-2 (CVLT2) and the Brief Visuospatial Memory Test-Revised (BVMT-R)

  3. Change from Baseline in the Multiple sclerosis functional composite (MSFC) scores at Month 48 [ Time Frame: Baseline and Month 48 ]
    A clinical trial outcome measure of assessing the severity of multiple sclerosis (MS) primarily. used in research. The score is based on a combination of timed tests of walking, arm function, and cognitive ability. It is a three-part, standardized, quantitative, assessment instrument for use in clinical studies, particularly clinical trials, of MS. The MSFC can produce scores for each of the three individual measures as well as a composite score.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The target sample size for the MS group is 120. Eligible patients will be stratified based on their EDSS score. Based on the known distribution of EDSS scores, we will recruit 22 MS patients with a score between 0-2, 44 patients with a score between 2.5-4, 44 patients with a score between 4.5-6.0, and 22 patients with a score between 6.5-8. Data will also be acquired from a control group (n=30) that will be frequency-matched for age.
Criteria

Inclusion Criteria:

  • Able to provide informed consent.
  • Aged 18 years or older at the time of enrollment.
  • Able to read in either French or English.
  • Visual acuity of 20/100 in at least one eye (corrective glasses, contact lenses, surgery etc.

are permitted)

For patients only:

  • Confirmed diagnosis of MS with no signs of progressive increase in physical disability within the past six months.
  • Neurological condition is medically stable during the study visit.
  • Expanded Disability Status Scale (EDSS) score 0 - 8.0 at the initial visit.

Exclusion Criteria:

  • Evidence or medical history of psychiatric issues, which are known to also affect movements and oculomotor control.
  • Presence of co-morbid neurological conditions to avoid eye movement anomaly confounds (Strabismus, cranial nerve palsy, stroke-causing hemianopsia).
  • Diagnosis of macular edema or other pre-existing ocular conditions that would prevent a participant from performing the eye movement assessments.
  • Recent (less than three months from enrollment) start of, change of dose, or irregular use of, new prescription drugs known to influence ocular motor visual function, such as benzodiazepines, antipsychotics and anticonvulsants. Occasional use of benzodiazepines for medical procedures is permitted, at the investigator's discretion, but should not occur within a short time period prior to or during an eye movement assessment.

For healthy controls only:

  • Evidence or history of significant neurodegenerative disorder affecting brain function, e.g., multiple sclerosis (MS), Parkinson's disease (PD), amyotrophic lateral sclerosis (ALS), Dementia.

For MS patients only

  • Diagnosis of Clinically Isolated Syndrome (CIS), Radiologically Isolated Syndrome (RIS) or Primary Progressive MS (PPMS).
  • Patients who are currently experiencing a relapse or who have experienced a relapse within the last three months. A relapse is defined as appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event (McDonald et al. 2001). The abnormality must have been present for at least 24 hours and occurred in the absence of fever (< 37.5°C) or known infection.
  • Patients who have been undergoing disease-modifying therapy for less than three months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05061953


Locations
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Canada, Quebec
The Neuro Recruiting
Montreal, Quebec, Canada, H3A 2B4
Contact: Julian Santorelli, M.Eng    514-398-6191    julian.santorelli@mcgill.ca   
Contact: Pascale Patenaude, MSc.    514-398-7324    pascale.patenaude@mcgill.ca   
Principal Investigator: Paul Giacomini, MD         
Genge Partners, Inc. Recruiting
Montreal, Quebec, Canada, H4A 3T4
Contact: Adrien Poulin    438-874-8334    apoulin@gengepartners.com   
Principal Investigator: Alex Savariano, MD         
Sponsors and Collaborators
Innodem Neurosciences
Novartis
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Responsible Party: Innodem Neurosciences
ClinicalTrials.gov Identifier: NCT05061953    
Other Study ID Numbers: ETNA-ProgMS
First Posted: September 30, 2021    Key Record Dates
Last Update Posted: December 16, 2022
Last Verified: December 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases