ETNA-MS Device Validation Study

Completed

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT06256731

Run by

Innodem Neurosciences

People needed

60

Starts

2023-12-12

Expected to finish

2024-06-12

Last updated by the study team

2026-04-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• MS Integrated Center — Phoenix, Arizona, United States
• Michigan Institute for Neurological Disorders — Farmington Hills, Michigan, United States
• Memorial Healthcare — Owosso, Michigan, United States
• Premier Neurology Research, P.C. — Greenville, South Carolina, United States
• Rocky Mountain MS Research Group — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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