NCT04756700

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

Validation of DigiCog (BCCAMS App) and Konectom™ Tools, for Supporting Digitalized Clinical Assessment of Cognitive and Motor Functions in Patients With Multiple Sclerosis. DigiToms Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 158 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

The 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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	DigiCog (BCCAMS app)	Administered as specified in the treatment arm.
DIAGNOSTIC_TEST	Konectom Application	Administered as specified in the treatment arm.

Timeline

• Start date: 2020-10-12
• Primary completion: 2022-07-26
• Completion: 2022-07-26
• First posted: 2021-02-16
• Last updated: 2023-04-18

Locations

1 site across 1 country: France