Clinical trial NCT04756700: Validation of DigiCog and Konectom Tools to Support Digitalized Clinical Assessment in Multiple Sclerosis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2021-02-16
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

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

Primary outcomes:
measure: Raw Score of the Computerized Speed Cognitive Test (CSCT) using DigiCog (BCCAMS app)
timeFrame: Up to Day 28
measure: Raw Score of the Computerized Episodic Visual Memory Test (CEVMT) using DigiCog (BCCAMS app)
timeFrame: Up to Day 28
measure: Raw Score of the French Learning Test (FLT), using DigiCog (BCCAMS app)
timeFrame: Up to Day 28
Secondary outcomes:
measure: Sensitivity of the DigiCog (BCCAMS app) to detect CI in PwMS as compared to the Brief International Cognitive Assessment for MS (BICAMS)
timeFrame: Up to Day 28
measure: Specificity of the DigiCog (BCCAMS app) to detect CI in PwMS as compared to the BICAMS
timeFrame: Up to Day 28
measure: Accuracy of the DigiCog (BCCAMS app) to detect CI in PwMS as compared to the BICAMS
timeFrame: Up to Day 28
measure: Relationship between Depressive Symptoms with BDI FAST and Cognitive Performance ((BICAMS/DigiCog)
timeFrame: Up to Day 28
measure: Relationship Between Subjective Perception of CI with DailyCog and Cognitive Performance (BICAMS/DigiCog)
timeFrame: Up to Day 28
measure: Reliability of Konectom Digital Outcome Assessment (DOA) in HS and PwMS: Intraclass Correlation Coefficient (ICC) of the score for Cognitive Processing Speed test (CPS)
timeFrame: Up to Day 28
measure: Reliability of Konectom DOA in HS and PwMS: ICC of the score for Pinching Test
timeFrame: Up to Day 28
measure: Reliability of Konectom DOA HS and PwMS: ICC of the score for Drawing Test
timeFrame: Up to Day 28
measure: Reliability of Konectom DOA HS and PwMS: ICC of the score for Grip Force Tests
timeFrame: Up to Day 28
measure: Reliability of Konectom DOA in HS and PwMS: ICC of the score for 6-minute Walk Test (6MWT)
timeFrame: Up to Day 28
measure: Reliability of Konectom DOA in HS and PwMS: ICC of the score for U-turn Test (UTT)
timeFrame: Up to Day 28
measure: Reliability of Konectom DOA in HS and PwMS: ICC of the score for Static Balance test (SBT)
timeFrame: Up to Day 28
measure: Convergent Validity of Konectom DOA Against In-clinic Conventional Disability Outcome Assessment: CPS Versus Symbol Digit Modalities Test (SDMT) in PwMS
timeFrame: Up to Day 28
measure: Convergent Validity of Konectom DOA Against In-clinic Conventional Disability Outcome Assessment: Pinching Versus 9-Hole Peg Test (9HPT) in PwMS
timeFrame: Up to Day 28
measure: Convergent Validity of Konectom DOA Against In-clinic Conventional Disability Outcome Assessment: Drawing Versus 9HPT in PwMS
timeFrame: Up to Day 28
measure: Convergent Validity of Konectom DOA Against In-clinic Conventional Disability Outcome Assessment: Grip Force Test Versus 9HPT in PwMS
timeFrame: Up to Day 28
measure: Convergent Validity of Konectom DOA Against In-clinic Conventional Disability Outcome Assessment: SBT Versus Timed 25-foot Walk Test (T25FW) in PwMS
timeFrame: Up to Day 28
measure: Convergent Validity of Konectom DOA Against In-clinic Conventional Disability Outcome Assessment: UTT Versus T25FW in PwMS
timeFrame: Up to Day 28
measure: Convergent Validity of Konectom DOA Against In-clinic Conventional Disability Outcome Assessment: 6MWT Versus T25FW in PwMS
timeFrame: Up to Day 28
measure: Convergent Validity of Konectom DOA Against In-clinic Conventional Disability Outcome Assessment: Passive Mobility Versus T25FW in PwMS
timeFrame: Up to Day 28
measure: 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
timeFrame: Up to Day 28
measure: Difference in Konectom DOA (Self-administered at Home and In-clinic) Between PwMS and HS: CPS Score
timeFrame: Up to Day 28
measure: Difference in Konectom DOA (Self-administered at Home and In-clinic) Between PwMS and HS: Pinching Test Score
timeFrame: Up to Day 28
measure: Difference in Konectom DOA (Self-administered at Home and In-clinic) Between PwMS and HS: Drawing Test Score
timeFrame: Up to Day 28
measure: Difference in Konectom DOA (Self-administered at Home and In-clinic) Between PwMS and HS: Grip Force Test Score
timeFrame: Up to Day 28
measure: Difference in Konectom DOA (Self-administered at Home and In-clinic) Between PwMS and HS: 6MWT Score
timeFrame: Up to Day 28
measure: DDifference in Konectom DOA (Self-administered at Home and In-clinic) Between PwMS and HS: UTT Score
timeFrame: Up to Day 28
measure: Difference in Konectom DOA (Self-administered at Home and In-clinic) Between PwMS and HS: SBT Score
timeFrame: Up to Day 28
measure: Difference in Konectom DOA (Self-administered at Home and In-clinic) Between PwMS and HS: Mobility Behavior Score
timeFrame: Up to Day 28
measure: Difference in Konectom DOA (Self-administered at Home and In-clinic) Between PwMS and HS: Mood Scale Question (MSQ)
timeFrame: Up to Day 28
measure: Variability of the Participant Performance throughout Konectom™ DOAs Self-administered at Home in Free-living Environment in HS and PwMS: CPS Score
timeFrame: Up to Day 28
measure: Variability of the Participant Performance throughout Konectom™ DOAs Self-administered at Home in Free-living Environment in HS and PwMS: Pinching Test Score
timeFrame: Up to Day 28
measure: Variability of the Participant Performance throughout Konectom™ DOAs Self-administered at Home in Free-living Environment in HS and PwMS: Drawing Test Score
timeFrame: Up to Day 28
measure: Variability of the Participant Performance throughout Konectom™ DOAs Self-administered at Home in Free-living Environment in HS and PwMS: Grip Force Test Score
timeFrame: Up to Day 28
measure: Variability of the Participant Performance throughout Konectom™ DOAs Self-administered at Home in Free-living Environment in HS and PwMS: 6MWT Score
timeFrame: Up to Day 28
measure: Variability of the Participant Performance throughout Konectom™ DOAs Self-administered at Home in Free-living Environment in HS and PwMS: UTT Score
timeFrame: Up to Day 28
measure: Variability of the Participant Performance throughout Konectom™ DOAs Self-administered at Home in Free-living Environment in HS and PwMS: SBT Score
timeFrame: Up to Day 28
measure: Difference in Konectom DOA Between In-clinic Supervised Administration Versus Self-assessments in Free-living Environment in HS and PwMS
timeFrame: Up to Day 28
measure: 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
timeFrame: Up to Day 28
measure: Clinical Meaningfulness of Konectom DOA Against PRO: CPS Association with Cognitive/Psychological Items of the Multiple Sclerosis Impact Scale 29 (MSIS-29) in PwMS
timeFrame: Up to Day 28
measure: Clinical Meaningfulness of Konectom DOA Against PRO: CPS Association with Daily Cog in PwMS
timeFrame: Up to Day 28
measure: Clinical Meaningfulness of Konectom DOA Against PRO: Pinching Test Association with ABILHAND-56 in PwMS
timeFrame: Up to Day 28
measure: Clinical Meaningfulness of Konectom DOA Against PRO: Pinching Test Association with early MS manual ability questionnaires
timeFrame: Up to Day 28
measure: Clinical Meaningfulness of Konectom DOA Against PRO: Drawing Test Association with ABILHAND-56 in PwMS
timeFrame: Up to Day 28
measure: Clinical Meaningfulness of Konectom DOA Against PRO: Drawing Test Association with early MS manual ability questionnaires
timeFrame: Up to Day 28
measure: Clinical Meaningfulness of Konectom DOA Against PRO: Grip Force Test Association with ABILHAND-56 in PwMS
timeFrame: Up to Day 28
measure: Clinical Meaningfulness of Konectom DOA Against PRO: Grip Force Test Association with Early MS Manual Ability Questionnaires
timeFrame: Up to Day 28
measure: Clinical Meaningfulness of Konectom DOA Against PRO: SBT Association with Multiple Sclerosis Walking Scale 12 items (MSWS-12) in PwMS
timeFrame: Up to Day 28
measure: Clinical Meaningfulness of Konectom DOA Against PRO: SBT Association with Early MS Walking Ability-gait Questionnaires in PwMS
timeFrame: Up to Day 28
measure: Clinical Meaningfulness of Konectom DOA Against PRO: SBT Association with Ambulation-related Items of the MSIS-29 in PwMS
timeFrame: Up to Day 28
measure: Clinical Meaningfulness of Konectom DOA Against PRO: SBT Association with PDDS in PwMS
timeFrame: Up to Day 28
measure: Clinical Meaningfulness of Konectom DOA Against PRO: UTT Association with MSWS-12 in PwMS
timeFrame: Up to Day 28
measure: Clinical Meaningfulness of Konectom DOA Against PRO: UTT Association with Early MS Walking Ability-gait Questionnaires in PwMS
timeFrame: Up to Day 28
measure: Clinical Meaningfulness of Konectom DOA Against PRO: UTT Association with Ambulation-related Items of the MSIS-29 in PwMS
timeFrame: Up to Day 28
measure: Clinical Meaningfulness of Konectom DOA Against PRO: UTT Association with PDDS in PwMS
timeFrame: Up to Day 28
measure: Clinical Meaningfulness of Konectom DOA Against PRO: 6MWT Association with MSWS-12 in PwMS
timeFrame: Up to Day 28
measure: Clinical Meaningfulness of Konectom DOA Against PRO: 6MWT Association with Early MS Walking Ability-gait Questionnaires in PwMS
timeFrame: Up to Day 28
measure: Clinical Meaningfulness of Konectom DOA Against PRO: 6MWT Association with Ambulation-related Items of the MSIS-29 in PwMS
timeFrame: Up to Day 28
measure: Clinical Meaningfulness of Konectom DOA Against PRO: 6MWT Association with PDDS in PwMS
timeFrame: Up to Day 28
measure: Clinical Meaningfulness of Konectom DOA Against PRO: Passive Mobility Association with MSWS-12 in PwMS
timeFrame: Up to Day 28
measure: Clinical Meaningfulness of Konectom DOA Against PRO: Passive Mobility Association with Early MS Walking Ability-gait Questionnaires in PwMS
timeFrame: Up to Day 28
measure: Clinical Meaningfulness of Konectom DOA Against PRO: Passive Mobility Association with Ambulation-related Items of the MSIS-29 in PwMS
timeFrame: Up to Day 28
measure: Clinical Meaningfulness of Konectom DOA Against PRO: Passive Mobility Association with PDDS in PwMS
timeFrame: Up to Day 28
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Research Site
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: