Validation of the ETNA-MS device for assessing disability in Multiple Sclerosis patients
ETNA-MS Device Validation Study
This study is testing a new eye-tracking device to see if it can accurately measure disability in people with Multiple Sclerosis compared to traditional doctor evaluations.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Innodem Neurosciences Industry-sponsored |
| Locations | 5 sites (Phoenix, Arizona and 4 other locations) |
| Trial ID | NCT06256731 on ClinicalTrials.gov |
What this trial studies
This observational study aims to validate the effectiveness of the ETNA-MS device developed by Innodem in assessing the disability status of patients with Multiple Sclerosis (MS). The study will involve a multi-site cross-sectional design where eligible MS patients will undergo eye-tracking assessments to determine their Expanded Disability Status Scale (EDSS) scores. The results from the device will be compared to in-person evaluations conducted by neurologists to assess agreement in disability status. Participants will also undergo brief functional and cognitive assessments to provide a comprehensive understanding of their condition.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of Multiple Sclerosis and an EDSS score between 1.0 and 4.5.
Not a fit: Patients with significant neuropsychiatric disorders or other neurological conditions that impair eye movements may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy and efficiency of disability assessments in MS patients, leading to better-informed clinical decisions.
How similar studies have performed: While the approach of using eye-tracking technology for disability assessment is innovative, similar studies have shown promise in enhancing diagnostic accuracy in neurological conditions.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Phoenix, Arizona and 4 other locations
- MS Integrated Center — Phoenix, Arizona, United States (Recruiting)
- Michigan Institute for Neurological Disorders — Farmington Hills, Michigan, United States (Not_yet_recruiting)
- Memorial Healthcare — Owosso, Michigan, United States (Recruiting)
- Premier Neurology Research, P.C. — Greenville, South Carolina, United States (Recruiting)
- Rocky Mountain MS Research Group — Salt Lake City, Utah, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.