Validation of DigiCog and Konectom Tools to Support Digitalized Clinic

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

CompletedNot a drug-phase studyMS (type not specified)NCT04756700

We could not find results for this trial

What it found

No results found

We found no results in the registry or in papers.

This trial finished 4 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • DigiCog (BCCAMS app)
  • Konectom Application

What it measured

Main measures

  • Raw Score of the Computerized Speed Cognitive Test (CSCT) using DigiCog (BCCAMS app)

    Up to Day 28

    Thinking and memory

  • Raw Score of the Computerized Episodic Visual Memory Test (CEVMT) using DigiCog (BCCAMS app)

    Up to Day 28

    Thinking and memory

  • Raw Score of the French Learning Test (FLT), using DigiCog (BCCAMS app)

    Up to Day 28

Other measures (63)

  • Sensitivity of the DigiCog (BCCAMS app) to detect CI in PwMS as compared to the Brief International Cognitive Assessment for MS (BICAMS)

    Up to Day 28

    Thinking and memory

  • Specificity of the DigiCog (BCCAMS app) to detect CI in PwMS as compared to the BICAMS

    Up to Day 28

    Thinking and memory

  • Accuracy of the DigiCog (BCCAMS app) to detect CI in PwMS as compared to the BICAMS

    Up to Day 28

    Thinking and memory

  • Relationship between Depressive Symptoms with BDI FAST and Cognitive Performance ((BICAMS/DigiCog)

    Up to Day 28

    Thinking and memoryMood and sleep

  • Relationship Between Subjective Perception of CI with DailyCog and Cognitive Performance (BICAMS/DigiCog)

    Up to Day 28

    Thinking and memory

  • 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

    Thinking and memory

  • 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

    Arm and hand function

  • Reliability of Konectom DOA in HS and PwMS: ICC of the score for 6-minute Walk Test (6MWT)

    Up to Day 28

    Walking and mobility

Who could take part

MS (type not specified) · 18 to 64

Show the full 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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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    History

      1. Started

        Oct 2020

      2. Main results due

        Jul 2022

      3. Finished

        Jul 2022

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