Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04756700
Status:
COMPLETED
Last Update Posted:
2023-04-18
First Post:
2021-02-12
Brief Title:
Validation of DigiCog and Konectom Tools to Support Digitalized Clinical Assessment in Multiple Sclerosis
Sponsor:
Biogen
Organization:
Biogen
Study Overview
Official Title:
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
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DigiToms
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-A01801-38 | OTHER | ANSM | None |