Status:
COMPLETED
Validation of DigiCog and Konectom Tools to Support Digitalized Clinical Assessment in Multiple Sclerosis
Lead Sponsor:
Biogen
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-64 years
Phase:
NA
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 \[Compute...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 26 2022
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT04756700
Start Date
October 12 2020
End Date
July 26 2022
Last Update
April 18 2023
Active Locations (1)
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1
Research Site
Bordeaux, France, 33000