NCT06256731

ETNA-MS Device Validation Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: Innodem Neurosciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Sclerosis

Interventions

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

Timeline

• Start date: 2023-12-12
• Primary completion: 2024-06-12
• Completion: 2024-06-12
• First posted: 2024-02-13
• Last updated: 2026-04-01

Locations

5 sites across 1 country: United States