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Single cohort of MS patients with EDSS 1.0-4.5 for Multiple Sclerosis (ETNA-MS Trial)
N/A
Recruiting
Research Sponsored by Innodem Neurosciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1
Awards & highlights
ETNA-MS Trial 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.
ETNA-MS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Validate the effectiveness of the ETNA-MS device to estimate MS disease severity/status as estimated by the EDSS.
Secondary outcome measures
Validate that the ETNA-MS device has good test-retest reliability for estimating the EDSS.
Validate the effectiveness of the ETNA-MS device to estimate the 9-Hole Peg Test (9-HPT) as part of the Multiple sclerosis functional composite (MSFC).
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).
+3 moreETNA-MS Trial Design
1Treatment groups
Experimental Treatment
Group I: Single cohort of MS patients with EDSS 1.0-4.5Experimental Treatment1 Intervention
Confirmed diagnosis of MS with an EDSS score ranging from 1.0 and 4.5.
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Who is running the clinical trial?
Innodem NeurosciencesLead Sponsor
7 Previous Clinical Trials
1,288 Total Patients Enrolled
4 Trials studying Multiple Sclerosis
508 Patients Enrolled for Multiple Sclerosis
Syneos HealthOTHER
172 Previous Clinical Trials
68,394 Total Patients Enrolled
2 Trials studying Multiple Sclerosis
206 Patients Enrolled for Multiple Sclerosis
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