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DigiToms

Validation of DigiCog and Konectom Tools to Support Digitalized Clinical Assessment in Multiple Sclerosis

Ensayo de BIOGEN INC. en Esclerosis multiple.

Más ensayos de: Esclerosis múltiple.

Fase

Sin fase asignada

Estado

Completado

Participantes

158

previstos

Centros

1

Fin del objetivo primario

jul 2022

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en oct 2020.

Qué mide

Puntuacion bruta de la Prueba Cognitiva de Velocidad Computarizada (CSCT) usando DigiCog (aplicacion BCCAMS) (hasta el dia 28)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe primary objective of this study is to establish scores of Cognitive impairment (CI) of the 3 DigiCog \[Brief Computerized Cognitive Assessment for Multiple Sclerosis (BCCAMS) app\] tests \[Computerized Speed Cognitive Test (CSCT), Computerized Episodic Visual Memory Test (CEVMT) and the French Learning Test (FLT), a verbal memory test similar to the CVLT\], using a tablet application in a sample of healthy participants matched to persons with MS (PwMS). The secondary objectives of this study are to determine the ability of the DigiCog app to detect cognitive impairment (CI) compared to the classical Brief International Cognitive Assessment for MS (BICAMS) in PwMS; to determine the relationship between depressive symptoms and cognitive performance in Multiple Sclerosis (MS) sample; to determine the relationship between subjective perception of CI and cognitive performance ; to evaluate the reliability of Konectom™ digital outcome assessments (DOAs) in healthy subjects (HS) and PwMS; to evaluate the convergent validity of Konectom™ digital outcome assessments (DOAs) against in-clinic conventional disability outcome assessments in PwMS; to evaluate differences in Konectom™ DOAs \[self administered at home and in-clinic\] between PwMS and HS; to evaluate the variability of Konectom™ DOAs self-administered at home in free-living environment in HS and PwMS; to compare Konectom™ DOAs between in-clinic supervised administration versus self-assessments in free-living environment in HS and PwMS; to evaluate the clinical meaningfulness of Konectom™ DOAs against Patient-Reported Outcomes (PRO) in PwMS.

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Ficha completa en ClinicalTrials.gov (NCT04756700), actualizada en abr 2023.