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Neurostatus-SMARTCARE in Comparison to Standard Neurostatus-EDSS®

NCT05575843 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2024-07-23

No results posted yet for this study

Summary

The Expanded Disability Status Scale (EDSS) is the gold-standard in assessing disability in Multiple Sclerosis (MS). Its current digital form, the Neurostatus-eEDSS®, often serves as primary endpoint in MS clinical trials.

The pandemic revealed the need for telemedical alternatives to the in-clinic assessment. Therefore, Neurostatus-SMARTCARE was developed: A trained and certified non-neurologist Health Care Professional (HCP) examines the patient while the examination is being video-recorded. The stored video allows a neurologist to re-assess the examination at a later point of time. The future application could be in-home visits through HCPs, in decentralized clinical trials as well as in routine care.

In this study, the concordance rate of Neurostatus examinations between neurologists and HCPs is investigated. With a concordance rate significantly higher than 80%, Neurostatus-SMARTCARE by HCPs can be considered equal to the standard Neurostatus-EDSS by neurologists.

Conditions

  • Multiple Sclerosis (MS)

Interventions

OTHER

Neurostatus-SMARTCARE

The Neurostatus-EDSS is assessed by HCPs while the examination is video-recorded. HCPs underwent extended training. For details of the examination refer to the second section of the detailed description.

OTHER

Standard Neurostatus-EDSS

The Neurostatus-EDSS is assessed by neurologists while the examination is video-recorded. Neurologists underwent standard training.

Sponsors & Collaborators

  • Novartis Pharma AG, Basel, Switzerland

    collaborator UNKNOWN

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Ludwig Kappos, Prof. Dr. med. Dr. h. c. mult. · Foundation Clinical Neuroimmunology and Neuroscience Basel (RC2NB)

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-09
Primary Completion
2023-11-17
Completion
2024-03-01

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05575843 on ClinicalTrials.gov