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ETNA-MS Device Validation Study

CompletedN/A

Sponsor: Innodem Neurosciences

Conditions: Multiple Sclerosis

Interventions: Eye-Tracking

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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.

Locations (5)

Phoenix, Arizona, United States
Farmington Hills, Michigan, United States
Owosso, Michigan, United States
Greenville, South Carolina, United States
Salt Lake City, Utah, United States