Multiple SclerosisDigiTomsNCT04756700
Validation of DigiCog and Konectom Tools to Support Digitalized Clinical Assessment in Multiple Sclerosis
A study testing DigiCog (BCCAMS app) and Konectom Application in people with Multiple Sclerosis, run by Biogen at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- DigiCog (BCCAMS app) and Konectom Application
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteFrance
- Study dates
- 12 Oct 2020to 26 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 21Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- DigiCog (BCCAMS app), Konectom Application
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DigiCog (BCCAMS app)Diagnostic test
Administered as specified in the treatment arm.
Konectom ApplicationDiagnostic test
Administered as specified in the treatment arm.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Participants | Experimental | 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. Receives: Diagnostic Test: DigiCog (BCCAMS app); Diagnostic Test: Konectom Application |
| PwMS: Participants with MS | Experimental | 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. Receives: Diagnostic Test: DigiCog (BCCAMS app); Diagnostic Test: Konectom Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to Day 28
Secondary outcomes (63)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: Up to Day 28
Reliability of Konectom DOA in HS and PwMS: ICC of the score for Pinching Test
Measured: Up to Day 28
Reliability of Konectom DOA HS and PwMS: ICC of the score for Drawing Test
Measured: Up to Day 28
Reliability of Konectom DOA HS and PwMS: ICC of the score for Grip Force Tests
Measured: Up to Day 28
Reliability of Konectom DOA in HS and PwMS: ICC of the score for 6-minute Walk Test (6MWT)
Measured: Up to Day 28
Reliability of Konectom DOA in HS and PwMS: ICC of the score for U-turn Test (UTT)
Measured: Up to Day 28
Reliability of Konectom DOA in HS and PwMS: ICC of the score for Static Balance test (SBT)
Measured: 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
Measured: 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
Measured: Up to Day 28
Convergent Validity of Konectom DOA Against In-clinic Conventional Disability Outcome Assessment: Drawing Versus 9HPT in PwMS
Measured: Up to Day 28
Convergent Validity of Konectom DOA Against In-clinic Conventional Disability Outcome Assessment: Grip Force Test Versus 9HPT in PwMS
Measured: 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
Measured: Up to Day 28
Convergent Validity of Konectom DOA Against In-clinic Conventional Disability Outcome Assessment: UTT Versus T25FW in PwMS
Measured: Up to Day 28
Convergent Validity of Konectom DOA Against In-clinic Conventional Disability Outcome Assessment: 6MWT Versus T25FW in PwMS
Measured: Up to Day 28
Convergent Validity of Konectom DOA Against In-clinic Conventional Disability Outcome Assessment: Passive Mobility Versus T25FW in PwMS
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to Day 28
Difference in Konectom DOA (Self-administered at Home and In-clinic) Between PwMS and HS: Mood Scale Question (MSQ)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to Day 28
Difference in Konectom DOA Between In-clinic Supervised Administration Versus Self-assessments in Free-living Environment in HS and PwMS
Measured: 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
Measured: 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
Measured: Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: CPS Association with Daily Cog in PwMS
Measured: Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: Pinching Test Association with ABILHAND-56 in PwMS
Measured: Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: Pinching Test Association with early MS manual ability questionnaires
Measured: Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: Drawing Test Association with ABILHAND-56 in PwMS
Measured: Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: Drawing Test Association with early MS manual ability questionnaires
Measured: Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: Grip Force Test Association with ABILHAND-56 in PwMS
Measured: Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: Grip Force Test Association with Early MS Manual Ability Questionnaires
Measured: Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: SBT Association with Multiple Sclerosis Walking Scale 12 items (MSWS-12) in PwMS
Measured: Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: SBT Association with Early MS Walking Ability-gait Questionnaires in PwMS
Measured: Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: SBT Association with Ambulation-related Items of the MSIS-29 in PwMS
Measured: Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: SBT Association with PDDS in PwMS
Measured: Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: UTT Association with MSWS-12 in PwMS
Measured: Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: UTT Association with Early MS Walking Ability-gait Questionnaires in PwMS
Measured: Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: UTT Association with Ambulation-related Items of the MSIS-29 in PwMS
Measured: Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: UTT Association with PDDS in PwMS
Measured: Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: 6MWT Association with MSWS-12 in PwMS
Measured: Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: 6MWT Association with Early MS Walking Ability-gait Questionnaires in PwMS
Measured: Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: 6MWT Association with Ambulation-related Items of the MSIS-29 in PwMS
Measured: Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: 6MWT Association with PDDS in PwMS
Measured: Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: Passive Mobility Association with MSWS-12 in PwMS
Measured: Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: Passive Mobility Association with Early MS Walking Ability-gait Questionnaires in PwMS
Measured: Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: Passive Mobility Association with Ambulation-related Items of the MSIS-29 in PwMS
Measured: Up to Day 28
Clinical Meaningfulness of Konectom DOA Against PRO: Passive Mobility Association with PDDS in PwMS
Measured: Up to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start12 Oct 2020
- Primary completion26 Jul 2022
- Study completion26 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04756700
- Sponsor's protocol ID
- FR-MSG-11654
- Other IDs
- 2020-A01801-38
- Acronym
- DigiToms
- Status last verified
- Apr 2023
- First submitted
- 12 Feb 2021
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04756700
- Acronym / sponsor ID
- DigiToms / FR-MSG-11654
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 12 Oct 2020 (actual)
- Primary completion
- 26 Jul 2022 (actual)
- Study completion
- 26 Jul 2022 (actual)
- First posted
- 16 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Participants | Experimental | Diagnostic Test: DigiCog (BCCAMS app), Diagnostic Test: Konectom ApplicationHealthy 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. |
| PwMS: Participants with MS | Experimental | Diagnostic Test: DigiCog (BCCAMS app), Diagnostic Test: Konectom ApplicationParticipants 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Expanded Disability Status Scale (EDSS) score ≤ 6.
- Multiple Sclerosis (MS) diagnosis according to 2017 revised McDonald criteria.
- Gender-, age- and education-matched with Multiple Sclerosis participants.
Key exclusion criteria (21 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DigiCog (BCCAMS app)Administered as specified in the treatment arm. | Diagnostic test | Healthy Participants, PwMS: Participants with MS |
| Konectom ApplicationAdministered as specified in the treatment arm. | Diagnostic test | Healthy Participants, PwMS: Participants with MS |
Primary outcome
Raw Score of the Computerized Speed Cognitive Test (CSCT) using DigiCog (BCCAMS app)
Time frame: Up to Day 28
Number of the correct answers will provide raw score of CSCT from which regression based norms will be calculated.
Raw Score of the Computerized Episodic Visual Memory Test (CEVMT) using DigiCog (BCCAMS app)
Time frame: Up to Day 28
Total number of correct answers of the 3 trials will provide raw score of CEVMT from which regression based norms will be calculated.
Raw Score of the French Learning Test (FLT), using DigiCog (BCCAMS app)
Time frame: Up to Day 28
Total number of correct answers for the 5 trials will provide raw score of FLT from which regression based norms will be calculated.
63 secondary outcomes
Sensitivity of the DigiCog (BCCAMS app) to detect CI in PwMS as compared to the Brief International Cognitive Assessment for MS (BICAMS)
Time frame: Up to Day 28
Specificity of the DigiCog (BCCAMS app) to detect CI in PwMS as compared to the BICAMS
Time frame: Up to Day 28
Accuracy of the DigiCog (BCCAMS app) to detect CI in PwMS as compared to the BICAMS
Time frame: Up to Day 28
Relationship between Depressive Symptoms with BDI FAST and Cognitive Performance ((BICAMS/DigiCog)
Time frame: Up to Day 28
Relationship Between Subjective Perception of CI with DailyCog and Cognitive Performance (BICAMS/DigiCog)
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
Time frame: Up to Day 28
Difference in Konectom DOA (Self-administered at Home and In-clinic) Between PwMS and HS: Pinching Test Score
Time frame: Up to Day 28
Difference in Konectom DOA (Self-administered at Home and In-clinic) Between PwMS and HS: Drawing Test Score
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
Time frame: Up to Day 28
Difference in Konectom DOA (Self-administered at Home and In-clinic) Between PwMS and HS: 6MWT Score
Time frame: Up to Day 28
DDifference in Konectom DOA (Self-administered at Home and In-clinic) Between PwMS and HS: UTT Score
Time frame: Up to Day 28
Difference in Konectom DOA (Self-administered at Home and In-clinic) Between PwMS and HS: SBT Score
Time frame: Up to Day 28
Difference in Konectom DOA (Self-administered at Home and In-clinic) Between PwMS and HS: Mobility Behavior Score
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: Yes. In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Biogen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DigiCog (BCCAMS app) and Konectom Application in people with Multiple Sclerosis, run by Biogen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Raw Score of the Computerized Speed Cognitive Test (CSCT) using DigiCog (BCCAMS app) (time frame: Up to Day 28). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.