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

NCT ID: NCT04756700

Last Updated: 2023-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 158 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-12
• Study Completion Date: 2022-07-26

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Healthy Participants

Healthy participants matched with PwMS will have their cognitive and motor functions assessed using the DigiCog (BCCAMS app) tablet once in clinic and Konectom smartphone-based application for 2 days in clinic and at least 15 days at home.

Group Type: EXPERIMENTAL

DigiCog (BCCAMS app)

Intervention Type: DIAGNOSTIC_TEST

Administered as specified in the treatment arm.

Konectom Application

Intervention Type: DIAGNOSTIC_TEST

Administered as specified in the treatment arm.

PwMS: Participants with MS

Participants with MS will have their cognitive and motor functions assessed using the DigiCog (BCCAMS app) tablet once in clinic and Konectom smartphone-based application for 2 days in clinic and at least 15 days at home.

Group Type: EXPERIMENTAL

DigiCog (BCCAMS app)

Intervention Type: DIAGNOSTIC_TEST

Administered as specified in the treatment arm.

Konectom Application

Intervention Type: DIAGNOSTIC_TEST

Administered as specified in the treatment arm.

Interventions

DigiCog (BCCAMS app)

Administered as specified in the treatment arm.

Intervention Type: DIAGNOSTIC_TEST

Konectom Application

Administered as specified in the treatment arm.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

For PwMS:

• Expanded Disability Status Scale (EDSS) score ≤ 6.
• Multiple Sclerosis (MS) diagnosis according to 2017 revised McDonald criteria.

For Healthy Participants:

• Gender-, age- and education-matched with Multiple Sclerosis participants.

Exclusion Criteria

For PwMS:

• Severe depression according to Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) classification or severe on-going psychiatric condition, as per evaluation by the investigator;
• Change of Disease Modifiying Treatment (DMT) in the last 1 month;
• Any clinically significant neurological disorders other than MS, as per evaluation by the investigator;
• Any change of psychotropic treatment in the last 1 month;
• Clinically significant addiction (alcohol or other drug abuse), as per evaluation by the investigator;
• Recent acute relapse or disability worsening (less than one month);
• Steroid course in the previous month;
• Neuropsychological testing with the following tests in the previous year: Full BICAMS or DigiCog (BCCAMS app) battery, Fatigue Scale for Motor and Congnitive functions (FSMC), Computerized speed cognitive test (CSCT), Computerized Episodic Visual Memory Test (CEVMT), French Learning Test (FLT), Cognitive processing speed (CPS), Symbol Digit Modalities Test (SDMT);
• Developmental learning disabilities, as per evaluation by the investigator;
• Pregnant or breastfeeding women

For Health Participants:

• Severe depression (according to DSM-5 classification) or severe on-going psychiatric condition, as per evaluation by the investigator;
• Any clinically significant neurological disorders, as per evaluation by the investigator;
• Any psychotropic therapy consumption;
• Clinically significant addiction (alcohol or other drug abuse), as per evaluation by the investigator;
• Clinically significant cognitive complaint(s), as per evaluation by the investigator;
• Previous participation in other cognitive study using the same tests (Full BICAMS or DigiCog (BCCAMS app) battery, Fatigue Scale for Motor and Congnitive functions (FSMC), Computerized speed cognitive test (CSCT), Computerized Episodic Visual Memory Test (CEVMT), French Learning Test (FLT), Cognitive processing speed (CPS), Symbol Digit Modalities Test (SDMT));
• Developmental learning disabilities, as per evaluation by the investigator;
• Pregnant or breastfeeding women.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Biogen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

Research Site

Bordeaux, , France

Countries

France

Other Identifiers

2020-A01801-38

Identifier Type: OTHER

Identifier Source: secondary_id

FR-MSG-11654

Identifier Type: -

Identifier Source: org_study_id