Clinical trial NCT06256731: ETNA-MS Device Validation Study
Official title: ETNA-MS Device Validation Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Sclerosis
Lead sponsor: Innodem Neurosciences
Sponsor class: INDUSTRY
Collaborators: name: Syneos Health
First posted: 2024-02-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Our target sample size for the MS group is 60. Eligible patients with MS will be selected and categorized based on their EDSS score.

Brief 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.

Detailed 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.

Primary outcomes:
measure: Validate the effectiveness of the ETNA-MS device to estimate MS disease severity/status as estimated by the EDSS.
timeFrame: Day 1
Secondary outcomes:
measure: Validate that the ETNA-MS device has good test-retest reliability for estimating the EDSS.
timeFrame: Day 1
measure: Validate the effectiveness of the ETNA-MS device to estimate the Symbol Digit Modalities Test (SDMT) as part of the Brief International Cognitive Assessment for MS (BICAMS).
timeFrame: Day 1
measure: Validate the effectiveness of the ETNA-MS device to estimate the Brief Visuospatial Memory Test-Revised (BVMT-R) as part of the Brief International Cognitive Assessment for MS (BICAMS).
timeFrame: Day 1
measure: Validate the effectiveness of the ETNA-MS device to estimate the Rey Auditory Verbal Learning Test (RAVLT) as part of the Brief International Cognitive Assessment for MS (BICAMS).
timeFrame: Day 1
measure: Validate the effectiveness of the ETNA-MS device to estimate the Timed 25-foot walk as part of the Multiple sclerosis functional composite (MSFC).
timeFrame: Day 1
measure: Validate the effectiveness of the ETNA-MS device to estimate the 9-Hole Peg Test (9-HPT) as part of the Multiple sclerosis functional composite (MSFC).
timeFrame: Day 1
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: MS Integrated Center
state: Arizona
city: Farmington Hills
country: United States
facility: Michigan Institute for Neurological Disorders
state: Michigan
city: Owosso
country: United States
facility: Memorial Healthcare
state: Michigan
city: Greenville
country: United States
facility: Premier Neurology Research, P.C.
state: South Carolina
city: Salt Lake City
country: United States
facility: Rocky Mountain MS Research Group
state: Utah
Study officials:
References: