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

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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Diagnostic test: DigiCog (BCCAMS app); Diagnostic test: Konectom Application

• Study Type: Interventional
• Enrollment (Actual): 158
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33000
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 62 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

NOTE: Other protocol defined inclusion/ exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Diagnostic test: DigiCog (BCCAMS app); Administered as specified in the treatment arm.; Diagnostic test: Konectom Application; Administered as specified in the treatment arm.
Experimental: 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.	Diagnostic test: DigiCog (BCCAMS app); Administered as specified in the treatment arm.; Diagnostic test: Konectom Application; Administered as specified in the treatment arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Raw Score of the Computerized Speed Cognitive Test (CSCT) using DigiCog (BCCAMS app)	Number of the correct answers will provide raw score of CSCT from which regression based norms will be calculated.	Up to Day 28
Raw Score of the Computerized Episodic Visual Memory Test (CEVMT) using DigiCog (BCCAMS app)	Total number of correct answers of the 3 trials will provide raw score of CEVMT from which regression based norms will be calculated.	Up to Day 28
Raw Score of the French Learning Test (FLT), using DigiCog (BCCAMS app)	Total number of correct answers for the 5 trials will provide raw score of FLT from which regression based norms will be calculated.	Up to Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of the DigiCog (BCCAMS app) to detect CI in PwMS as compared to the Brief International Cognitive Assessment for MS (BICAMS)	CI will be defined for DigiCog (BCCAMS app) as one or more abnormal test within the MS sample for DigiCog (BCCAMS app) as well as the BICAMS. The reference will be CI defined as one or more abnormal BICAMS test.	Up to Day 28
Specificity of the DigiCog (BCCAMS app) to detect CI in PwMS as compared to the BICAMS	CI will be defined for DigiCog (BCCAMS app) as one or more abnormal test within the MS sample for DigiCog (BCCAMS app) as well as the BICAMS. The reference will be CI defined as one or more abnormal BICAMS test.	Up to Day 28
Accuracy of the DigiCog (BCCAMS app) to detect CI in PwMS as compared to the BICAMS	CI will be defined for DigiCog (BCCAMS app) as one or more abnormal test within the MS sample for DigiCog (BCCAMS app) as well as the BICAMS. The reference will be CI defined as one or more abnormal BICAMS test.	Up to Day 28
Relationship between Depressive Symptoms with BDI FAST and Cognitive Performance ((BICAMS/DigiCog)	Depressive symptoms will be estimated by BDI FAST (depressive scale) score. The BICAMS is used as the reference for the cognitive performances. The BCCAMS app is evaluated by using DigiCog scores.	Up to Day 28
Relationship Between Subjective Perception of CI with DailyCog and Cognitive Performance (BICAMS/DigiCog)	Subjective perception of CI will be estimated by Daily Cog score. The BICAMS is used as the reference for the cognitive performances.	Up to Day 28
Reliability of Konectom Digital Outcome Assessment (DOA) in HS and PwMS: Intraclass Correlation Coefficient (ICC) of the score for Cognitive Processing Speed test (CPS)		Up to Day 28
Reliability of Konectom DOA in HS and PwMS: ICC of the score for Pinching Test		Up to Day 28
Reliability of Konectom DOA HS and PwMS: ICC of the score for Drawing Test		Up to Day 28
Reliability of Konectom DOA HS and PwMS: ICC of the score for Grip Force Tests		Up to Day 28
Reliability of Konectom DOA in HS and PwMS: ICC of the score for 6-minute Walk Test (6MWT)		Up to Day 28
Reliability of Konectom DOA in HS and PwMS: ICC of the score for U-turn Test (UTT)		Up to Day 28
Reliability of Konectom DOA in HS and PwMS: ICC of the score for Static Balance test (SBT)		Up to Day 28
Convergent Validity of Konectom DOA Against In-clinic Conventional Disability Outcome Assessment: CPS Versus Symbol Digit Modalities Test (SDMT) in PwMS		Up to Day 28
Convergent Validity of Konectom DOA Against In-clinic Conventional Disability Outcome Assessment: Pinching Versus 9-Hole Peg Test (9HPT) in PwMS		Up to Day 28
Convergent Validity of Konectom DOA Against In-clinic Conventional Disability Outcome Assessment: Drawing Versus 9HPT in PwMS		Up to Day 28
Convergent Validity of Konectom DOA Against In-clinic Conventional Disability Outcome Assessment: Grip Force Test Versus 9HPT in PwMS		Up to Day 28
Convergent Validity of Konectom DOA Against In-clinic Conventional Disability Outcome Assessment: SBT Versus Timed 25-foot Walk Test (T25FW) in PwMS		Up to Day 28
Convergent Validity of Konectom DOA Against In-clinic Conventional Disability Outcome Assessment: UTT Versus T25FW in PwMS		Up to Day 28
Convergent Validity of Konectom DOA Against In-clinic Conventional Disability Outcome Assessment: 6MWT Versus T25FW in PwMS		Up to Day 28
Convergent Validity of Konectom DOA Against In-clinic Conventional Disability Outcome Assessment: Passive Mobility Versus T25FW in PwMS		Up to Day 28
Convergent Validity of Konectom DOA Against In-clinic Conventional Disability Outcome Assessment: Konectom™ overall disability Versus Expanded Disability Status Scale (EDSS) and its Subscores in PwMS		Up to Day 28
Difference in Konectom DOA (Self-administered at Home and In-clinic) Between PwMS and HS: CPS Score	Difference between PwMS and HS in the scores of CPS test during each testing condition will be evaluated.	Up to Day 28
Difference in Konectom DOA (Self-administered at Home and In-clinic) Between PwMS and HS: Pinching Test Score	Difference between PwMS and HS in the score of pinching test during each testing condition will be evaluated	Up to Day 28
Difference in Konectom DOA (Self-administered at Home and In-clinic) Between PwMS and HS: Drawing Test Score	Difference between PwMS and HS in the score of drawing test during each testing condition will be evaluated.	Up to Day 28
Difference in Konectom DOA (Self-administered at Home and In-clinic) Between PwMS and HS: Grip Force Test Score	Difference between PwMS and HS in the score of grip force test during each testing condition will be evaluated.	Up to Day 28
Difference in Konectom DOA (Self-administered at Home and In-clinic) Between PwMS and HS: 6MWT Score	Difference between PwMS and HS in the score of 6MWT test during each testing condition will be evaluated.	Up to Day 28
DDifference in Konectom DOA (Self-administered at Home and In-clinic) Between PwMS and HS: UTT Score	Difference between PwMS and HS in the score of UTT test during each testing condition will be evaluated.	Up to Day 28
Difference in Konectom DOA (Self-administered at Home and In-clinic) Between PwMS and HS: SBT Score	Difference between PwMS and HS in the score of SBT test during each testing condition will be evaluated.	Up to Day 28
Difference in Konectom DOA (Self-administered at Home and In-clinic) Between PwMS and HS: Mobility Behavior Score	Difference between PwMS and HS in the score of mobility behavior test during each testing condition will be evaluated.	Up to Day 28
Difference in Konectom DOA (Self-administered at Home and In-clinic) Between PwMS and HS: Mood Scale Question (MSQ)		Up to Day 28
Variability of the Participant Performance throughout Konectom™ DOAs Self-administered at Home in Free-living Environment in HS and PwMS: CPS Score		Up to Day 28
Variability of the Participant Performance throughout Konectom™ DOAs Self-administered at Home in Free-living Environment in HS and PwMS: Pinching Test Score		Up to Day 28
Variability of the Participant Performance throughout Konectom™ DOAs Self-administered at Home in Free-living Environment in HS and PwMS: Drawing Test Score		Up to Day 28
Variability of the Participant Performance throughout Konectom™ DOAs Self-administered at Home in Free-living Environment in HS and PwMS: Grip Force Test Score		Up to Day 28
Variability of the Participant Performance throughout Konectom™ DOAs Self-administered at Home in Free-living Environment in HS and PwMS: 6MWT Score		Up to Day 28
Variability of the Participant Performance throughout Konectom™ DOAs Self-administered at Home in Free-living Environment in HS and PwMS: UTT Score		Up to Day 28
Variability of the Participant Performance throughout Konectom™ DOAs Self-administered at Home in Free-living Environment in HS and PwMS: SBT Score		Up to Day 28
Difference in Konectom DOA Between In-clinic Supervised Administration Versus Self-assessments in Free-living Environment in HS and PwMS		Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: CPS Association with Cognitive Sub-Scores of the Fatigue Scale for Motor and Cognitive Functions (FSMC) in PwMS		Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: CPS Association with Cognitive/Psychological Items of the Multiple Sclerosis Impact Scale 29 (MSIS-29) in PwMS		Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: CPS Association with Daily Cog in PwMS		Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: Pinching Test Association with ABILHAND-56 in PwMS		Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: Pinching Test Association with early MS manual ability questionnaires		Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: Drawing Test Association with ABILHAND-56 in PwMS		Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: Drawing Test Association with early MS manual ability questionnaires		Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: Grip Force Test Association with ABILHAND-56 in PwMS		Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: Grip Force Test Association with Early MS Manual Ability Questionnaires		Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: SBT Association with Multiple Sclerosis Walking Scale 12 items (MSWS-12) in PwMS		Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: SBT Association with Early MS Walking Ability-gait Questionnaires in PwMS		Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: SBT Association with Ambulation-related Items of the MSIS-29 in PwMS		Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: SBT Association with PDDS in PwMS		Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: UTT Association with MSWS-12 in PwMS		Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: UTT Association with Early MS Walking Ability-gait Questionnaires in PwMS		Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: UTT Association with Ambulation-related Items of the MSIS-29 in PwMS		Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: UTT Association with PDDS in PwMS		Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: 6MWT Association with MSWS-12 in PwMS		Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: 6MWT Association with Early MS Walking Ability-gait Questionnaires in PwMS		Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: 6MWT Association with Ambulation-related Items of the MSIS-29 in PwMS		Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: 6MWT Association with PDDS in PwMS		Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: Passive Mobility Association with MSWS-12 in PwMS		Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: Passive Mobility Association with Early MS Walking Ability-gait Questionnaires in PwMS		Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: Passive Mobility Association with Ambulation-related Items of the MSIS-29 in PwMS		Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: Passive Mobility Association with PDDS in PwMS		Up to Day 28

Collaborators and Investigators

• Sponsor: Biogen

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2020
• Primary Completion (Actual): July 26, 2022
• Study Completion (Actual): July 26, 2022

Study Registration Dates

• First Submitted: February 12, 2021
• First Submitted That Met QC Criteria: February 12, 2021
• First Posted (Actual): February 16, 2021

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 14, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: FR-MSG-11654; 2020-A01801-38 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No