Multicentre assessment of motor and sensory evoked potentials in multiple sclerosis: reliability and implications for clinical trials.
Motor evoked potentials
biomarker
mean detectable change
progressive MS
remyelination
response biomarker
sensory evoked potentials
test–retest reliability
Journal
Multiple sclerosis journal - experimental, translational and clinical
ISSN: 2055-2173
Titre abrégé: Mult Scler J Exp Transl Clin
Pays: United States
ID NLM: 101668877
Informations de publication
Date de publication:
Historique:
received:
21
11
2018
accepted:
23
03
2019
entrez:
10
5
2019
pubmed:
10
5
2019
medline:
10
5
2019
Statut:
epublish
Résumé
Motor and sensory evoked potentials (EP) are potential candidate biomarkers for clinical trials in multiple sclerosis. To determine test -retest reliability of motor EP (MEP) and sensory EP (SEP) and associated EP-scores in patients with multiple sclerosis. In three centres, 16 relapsing and five progressive multiple sclerosis patients had MEPs and SEPs 1-29 days apart. Five neurophysiologists independently marked latencies by central reading. By variance component analysis, we estimated the critical difference (absolute reliability) for cross-sectional group comparison, comparison of longitudinal group changes, within-subject minimal detectable change and defined within-subject improvement. Cortical SEP responses and cortico-muscular MEP latencies were more reliable than central conduction times. For comparison of 20 subjects per arm, cross-sectional group difference ranged from 0.7 to 3.9 ms and 1.1 to 1.7, group difference in longitudinal changes from 0.4 to 1.8 ms and 0.36 to 0.62, within-subject minimal detectable change from 1.2 to 5.8 ms and 1.2 to 2.0, within-subject improvement from 0.8 to 3.8ms and 0.8 to 1.3, for single EP modalities and EP scores, respectively. Multicentre EP assessment with central EP reading is feasible and reliable. The critical difference is reasonably low to detect significant group changes and to define responders. The results support the concept of using EP and EP-scores as candidate response biomarkers for quantification of disease progression and for studying remyelination in multiple sclerosis.
Sections du résumé
BACKGROUND
BACKGROUND
Motor and sensory evoked potentials (EP) are potential candidate biomarkers for clinical trials in multiple sclerosis.
OBJECTIVE
OBJECTIVE
To determine test -retest reliability of motor EP (MEP) and sensory EP (SEP) and associated EP-scores in patients with multiple sclerosis.
METHODS
METHODS
In three centres, 16 relapsing and five progressive multiple sclerosis patients had MEPs and SEPs 1-29 days apart. Five neurophysiologists independently marked latencies by central reading. By variance component analysis, we estimated the critical difference (absolute reliability) for cross-sectional group comparison, comparison of longitudinal group changes, within-subject minimal detectable change and defined within-subject improvement.
RESULTS
RESULTS
Cortical SEP responses and cortico-muscular MEP latencies were more reliable than central conduction times. For comparison of 20 subjects per arm, cross-sectional group difference ranged from 0.7 to 3.9 ms and 1.1 to 1.7, group difference in longitudinal changes from 0.4 to 1.8 ms and 0.36 to 0.62, within-subject minimal detectable change from 1.2 to 5.8 ms and 1.2 to 2.0, within-subject improvement from 0.8 to 3.8ms and 0.8 to 1.3, for single EP modalities and EP scores, respectively.
CONCLUSIONS
CONCLUSIONS
Multicentre EP assessment with central EP reading is feasible and reliable. The critical difference is reasonably low to detect significant group changes and to define responders. The results support the concept of using EP and EP-scores as candidate response biomarkers for quantification of disease progression and for studying remyelination in multiple sclerosis.
Identifiants
pubmed: 31069107
doi: 10.1177/2055217319844796
pii: 10.1177_2055217319844796
pmc: PMC6495443
doi:
Types de publication
Journal Article
Langues
eng
Pagination
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