Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2025-12-26 @ 6:05 AM
Study NCT ID:
NCT05661266
Status:
UNKNOWN
Last Update Posted:
2023-10-18
First Post:
2022-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigating Eye-Movement Biomarkers of Disease Severity and Cognition in Multiple Sclerosis
Sponsor:
Innodem Neurosciences
Organization:
Study Overview
Official Title:
Investigating Eye-Movement Biomarkers of Disease Severity and Cognition in Multiple Sclerosis
Status:
UNKNOWN
Status Verified Date:
2023-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The overarching goal of this research protocol is to acquire eye-tracking, cognitive, and disease-severity metrics in multiple sclerosis (MS) patients to further build up a database of MS patients and train a machine learning classifying algorithms to identify which eye-tracking metrics-or combination thereof-can serve as reliable markers of MS disease severity and cognitive status.
Detailed Description:
This study will use a single group design in a cohort of 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: