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

NCT04756700 | Completed

• 2 other identifiers: FR-MSG-116542020-A01801-38
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (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

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

  Up to Day 28

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

  Up to Day 28

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

  Up to Day 28

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

  Up to Day 28

Study Arms (2)

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.

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.

Diagnostic Test: DigiCog (BCCAMS app); Diagnostic Test: Konectom Application

Interventions

DigiCog (BCCAMS app) DIAGNOSTIC_TEST

Administered as specified in the treatment arm.

Healthy Participants; PwMS: Participants with MS

Konectom Application DIAGNOSTIC_TEST

Administered as specified in the treatment arm.

Healthy Participants; PwMS: Participants with MS

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Biogen: lead

Study Sites (1)

Research Site

Bordeaux, 33000, France

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2021
• First Posted: February 16, 2021
• Study Start: October 12, 2020
• Primary Completion: July 26, 2022
• Study Completion: July 26, 2022
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)