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Updated: Jun 4, 2025
A Protocol for the Use of Remotely-Supervised Transcranial Direct Current Stimulation tDCS in Multiple Sclerosis MS
Published on: December 26, 2015
Neurostatus-SMARTCARE clinical trial: Enabling health care professionals to assess EDSS for decentralized trials in
Giulia Mallucci1,2, Andrea Zimmer1, Nikolaos Sfikas3
1Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), Basel, Switzerland.
Background:
Neurostatus-Expanded Disability Status Scale (EDSS) is the standard measure used to assess impairment and disability in multiple sclerosis (MS) trials but requires trained expert neurologists.
Objectives:
This study aims to evaluate the concordance of Neurostatus-EDSS assessments from specially trained health care professionals (HCPs) and standardized trained neurologists.
Methods:
A Swiss multicenter, randomized, cross-over study with 100 people with MS. HCPs were trained to assess the Neurostatus-EDSS based on the newly developed SMARTCARE-EDSS training method.
Results:
The concordance rate between HCPs and neurologists was 0.87 (95% confidence interval (CI) = 0.815-0.925).
Conclusion:
Trained HCPs can reliably perform Neurostatus-EDSS assessments, supporting broader implementation and improved trial access.
