Multiple Sclerosis Clinical Trial

ETNA-MS Device Validation Study

Summary

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.

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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.

View Eligibility Criteria

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.

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

60

Study ID:

NCT06256731

Recruitment Status:

Recruiting

Sponsor:

Innodem Neurosciences

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There are 5 Locations for this study

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MS Integrated Center
Phoenix Arizona, 85018, United States More Info
Brandon McCravey
Contact
480-471-6132
[email protected]
Barry Hendin, MD
Principal Investigator
Loris Travis, MD
Sub-Investigator
Andrea Kessler, NP
Sub-Investigator
Michigan Institute for Neurological Disorders
Farmington Hills Michigan, 48334, United States More Info
Chloe Johnson
Contact
248-552-0010
[email protected]
Diana Atherton
Contact
248-552-0010
[email protected]
Martin Belkin, DO
Principal Investigator
Memorial Healthcare
Owosso Michigan, 48867, United States More Info
Virginia Williamson, BSN RN
Contact
989-725-9424
[email protected]
Jeanie Cote, MD
Principal Investigator
Paige Goulette, DNP
Sub-Investigator
Rosemarie Walch, DO
Sub-Investigator
Robert Pace, MD
Sub-Investigator
Premier Neurology Research, P.C.
Greenville South Carolina, 29605, United States More Info
Rebecca Sellers
Contact
864-655-4005
[email protected]
Mary Hughes, MD
Principal Investigator
Rocky Mountain MS Research Group
Salt Lake City Utah, 84103, United States More Info
Tammy Hoyt
Contact
801-408-5711
[email protected]
April Erwin, MD
Principal Investigator
Robert Miska, MD
Sub-Investigator

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

60

Study ID:

NCT06256731

Recruitment Status:

Recruiting

Sponsor:


Innodem Neurosciences

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