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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
158
Administered as specified in the treatment arm.
Administered as specified in the treatment arm.
Research Site
Bordeaux, France
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.
Time frame: 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.
Time frame: 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.
Time frame: Up to Day 28
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: Up to Day 28
Reliability of Konectom DOA in HS and PwMS: ICC of the score for Pinching Test
Time frame: Up to Day 28
Reliability of Konectom DOA HS and PwMS: ICC of the score for Drawing Test
Time frame: Up to Day 28
Reliability of Konectom DOA HS and PwMS: ICC of the score for Grip Force Tests
Time frame: Up to Day 28
Reliability of Konectom DOA in HS and PwMS: ICC of the score for 6-minute Walk Test (6MWT)
Time frame: Up to Day 28
Reliability of Konectom DOA in HS and PwMS: ICC of the score for U-turn Test (UTT)
Time frame: Up to Day 28
Reliability of Konectom DOA in HS and PwMS: ICC of the score for Static Balance test (SBT)
Time frame: 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
Time frame: 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
Time frame: Up to Day 28
Convergent Validity of Konectom DOA Against In-clinic Conventional Disability Outcome Assessment: Drawing Versus 9HPT in PwMS
Time frame: Up to Day 28
Convergent Validity of Konectom DOA Against In-clinic Conventional Disability Outcome Assessment: Grip Force Test Versus 9HPT in PwMS
Time frame: 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
Time frame: Up to Day 28
Convergent Validity of Konectom DOA Against In-clinic Conventional Disability Outcome Assessment: UTT Versus T25FW in PwMS
Time frame: Up to Day 28
Convergent Validity of Konectom DOA Against In-clinic Conventional Disability Outcome Assessment: 6MWT Versus T25FW in PwMS
Time frame: Up to Day 28
Convergent Validity of Konectom DOA Against In-clinic Conventional Disability Outcome Assessment: Passive Mobility Versus T25FW in PwMS
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to Day 28
Difference in Konectom DOA (Self-administered at Home and In-clinic) Between PwMS and HS: Mood Scale Question (MSQ)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to Day 28
Difference in Konectom DOA Between In-clinic Supervised Administration Versus Self-assessments in Free-living Environment in HS and PwMS
Time frame: 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
Time frame: 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
Time frame: Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: CPS Association with Daily Cog in PwMS
Time frame: Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: Pinching Test Association with ABILHAND-56 in PwMS
Time frame: Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: Pinching Test Association with early MS manual ability questionnaires
Time frame: Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: Drawing Test Association with ABILHAND-56 in PwMS
Time frame: Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: Drawing Test Association with early MS manual ability questionnaires
Time frame: Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: Grip Force Test Association with ABILHAND-56 in PwMS
Time frame: Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: Grip Force Test Association with Early MS Manual Ability Questionnaires
Time frame: Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: SBT Association with Multiple Sclerosis Walking Scale 12 items (MSWS-12) in PwMS
Time frame: Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: SBT Association with Early MS Walking Ability-gait Questionnaires in PwMS
Time frame: Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: SBT Association with Ambulation-related Items of the MSIS-29 in PwMS
Time frame: Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: SBT Association with PDDS in PwMS
Time frame: Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: UTT Association with MSWS-12 in PwMS
Time frame: Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: UTT Association with Early MS Walking Ability-gait Questionnaires in PwMS
Time frame: Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: UTT Association with Ambulation-related Items of the MSIS-29 in PwMS
Time frame: Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: UTT Association with PDDS in PwMS
Time frame: Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: 6MWT Association with MSWS-12 in PwMS
Time frame: Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: 6MWT Association with Early MS Walking Ability-gait Questionnaires in PwMS
Time frame: Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: 6MWT Association with Ambulation-related Items of the MSIS-29 in PwMS
Time frame: Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: 6MWT Association with PDDS in PwMS
Time frame: Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: Passive Mobility Association with MSWS-12 in PwMS
Time frame: Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: Passive Mobility Association with Early MS Walking Ability-gait Questionnaires in PwMS
Time frame: Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: Passive Mobility Association with Ambulation-related Items of the MSIS-29 in PwMS
Time frame: Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: Passive Mobility Association with PDDS in PwMS
Time frame: Up to Day 28
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