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.
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.
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.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 5 Locations for this study
Phoenix Arizona, 85018, United States More Info
Principal Investigator
Sub-Investigator
Sub-Investigator
Farmington Hills Michigan, 48334, United States More Info
Principal Investigator
Owosso Michigan, 48867, United States More Info
Principal Investigator
Sub-Investigator
Sub-Investigator
Sub-Investigator
Greenville South Carolina, 29605, United States More Info
Principal Investigator
Salt Lake City Utah, 84103, United States More Info
Principal Investigator
Sub-Investigator
How clear is this clinincal trial information?