Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06256731
Status:
RECRUITING
Last Update Posted:
2024-02-13
First Post:
2024-02-05
Brief Title:
ETNA-MS Device Validation Study
Sponsor:
Innodem Neurosciences
Organization:
Innodem Neurosciences
Study Overview
Official Title:
ETNA-MS Device Validation Study
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
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:
ETNA-MS
Brief Summary:
The overarching goal of this research protocol is to validate the effectiveness of Innodems 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
Study Oversight
Has Oversight DMC:
None
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?:
None