ETNA-MS Device Validation Study

Innodem Neurosciences

Status: Enrolling

Conditions: Multiple Sclerosis

Treatments: Device: Eye-Tracking

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06256731

IN-MS-001

Details and patient eligibility

About

The overarching goal of this research protocol is to validate the effectiveness of Innodem's ETNA-MS device in informing clinicians on the disability status of Multiple Sclerosis (MS) patients. Effectiveness of the device will be assessed by the level of agreement between the EDSS estimated by the device and the actual scores measured by the neurologist in-person assessments.

Full description

This study will use a multi-site cross-sectional design in a single cohort of Multiple Sclerosis (MS) patients. Eligible patients with MS will be selected and categorized based on their Expanded Disability Status Scale (EDSS) score. Patients eye movements will be captured using the patented eye-tracking technology at one single time point. In addition to the eye-tracking tests, patient phenotypes will be further detailed via brief functional and cognitive assessments using the EDSS, Brief International Cognitive Assessment for MS (BICAMS) and Multiple Sclerosis Functional Composite (MSFC). All patients will be required to participate in a single session.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Able to provide informed consent
• Aged 18 years or older at the time of enrolment
• Able to read in either English, Spanish or French
• Able to read the oculomotor task on-screen instructions at the testing distance (45 cm) with or without corrective lenses
• Confirmed diagnosis of MS as per the Macdonald criteria, irrespective of MS subtype (relapsing-remitting (RRMS), secondary-progressive (SPMS), primary-progressive (PPMS), and progressive-relapsing (PRMS))
• Neurologist-determined EDSS score between 1.0-4.5

Exclusion criteria

• Evidence or medical history of a neuropsychiatric disorder such as schizophrenia and autism, which are known to impair eye movements and oculomotor control.
• Presence of comorbid neurological conditions causing significant eye movement anomalies (such as 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.
• Having started a new prescription medication or having changed the dose of a medication known to influence ocular motor visual function (e.g. benzodiazepines, antipsychotics, and anticonvulsants) within the past three months.
• Participants with non-disease related physical impairments to a leg, hand, or arm (e.g., broken bone or severe sprain) that would not allow completion of the assessments.
• Having an EDSS score for which the desired sample size has been reached.

Trial design

60 participants in 1 patient group

Single cohort of MS patients with EDSS 1.0-4.5

Description:

Confirmed diagnosis of MS with an EDSS score ranging from 1.0 and 4.5.

Treatment:

Device: Eye-Tracking