ETNA-MS Device Validation Study

NCT06256731 | Completed

• 1 other identifier: IN-MS-001
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 5

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Validate the effectiveness of the ETNA-MS device to estimate MS disease severity/status as estimated by the EDSS.

  Evaluate the average level of agreement (within +/- 0.5 EDSS score) between the device-estimated EDSS score and the ground truth, that is the true EDSS score as established by a certified neurologist. The Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. It is widely used in clinical trials and in the assessment of people with MS. The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability. Scoring is based on an examination by a neurologist.

  Day 1

Secondary Outcomes (6)

• Validate that the ETNA-MS device has good test-retest reliability for estimating the EDSS.

  Day 1

• 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).

  Day 1

• 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).

  Day 1

• 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).

  Day 1

• Validate the effectiveness of the ETNA-MS device to estimate the Timed 25-foot walk as part of the Multiple sclerosis functional composite (MSFC).

  Day 1

Study Arms (1)

Single cohort of MS patients with EDSS 1.0-4.5

Confirmed diagnosis of MS with an EDSS score ranging from 1.0 and 4.5.

Device: Eye-Tracking

Interventions

Eye-Tracking DEVICE

Eye-tracking technology and algorithms used to successfully capture and track eye movements using an electronic tablet and the embedded camera of the device.

Single cohort of MS patients with EDSS 1.0-4.5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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.

Sponsors & Collaborators

• Innodem Neurosciences: lead
• Syneos Health: collaborator

Study Sites (5)

MS Integrated Center

Phoenix, Arizona, 85018, United States

Location

Michigan Institute for Neurological Disorders

Farmington Hills, Michigan, 48334, United States

Location

Memorial Healthcare

Owosso, Michigan, 48867, United States

Location

Premier Neurology Research, P.C.

Greenville, South Carolina, 29605, United States

Location

Rocky Mountain MS Research Group

Salt Lake City, Utah, 84103, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Eye-Tracking Technology

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Eye Movement Measurements; Diagnostic Techniques, Ophthalmological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 13, 2024
• Study Start: December 12, 2023
• Primary Completion: June 12, 2024
• Study Completion: June 12, 2024
• Last Updated: April 1, 2026

Record last verified: 2024-02

Locations

US (5)