CogMS - A Real-world Study Into Cognitive Impairment in People With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis; Cognitive Dysfunction
Study type: Observational

Summary: 
      The present study will investigate the correlation between objective and subjective cognition
      in multiple sclerosis. The study will also investigate the impact of covariates such as
      fatigue and depression, the relationship with the Expanded Disability Status Scale (EDSS) and
      brain volumetrics as measured on magnetic resonance imaging (MRI). Additionally, the study
      will provide insights into patients' experiences with cognition, and the usability of the
      used objective cognitive assessments.
    

Detailed description: 
      Cognitive impairment is a significant burden that affects 43 to 70% of persons with multiple
      sclerosis (pwMS) 1. Cognitive problems have been observed in the earliest stages of multiple
      sclerosis (MS) and multiple studies have provided evidence for the predictive value of early
      cognitive impairment for future disease progression 2-6. However, cognitive function is not
      often discussed with pwMS or routinely assessed by healthcare providers (HCPs) leading to
      sub-optimal treatment of cognitive problems in MS 7. Furthermore, cognitive dysfunction that
      can be reliably detected by objective measures is poorly recognized by pwMS, resulting in a
      disconnect between objective and subjective measures of cognitive function 8-10.

      The present study will investigate the correlation between what cognitive problems people
      with MS perceive and what objective cognitive testing actually shows. This study will also
      provide insights about the presence of this disconnect in different strata of the Expanded
      Disability Status Scale (EDSS) 11, and the relationship with possible confounders (MS
      symptoms, fatigue, etc.) and brain volumetrics as measured on magnetic resonance imaging
      (MRI).

      Study Design:

      CogMS is an observational, cross-sectional, remote, real-world study of cognitive function in
      patients with multiple sclerosis. We will investigate the correlation between subjective and
      objective patient self-evaluations of cognitive function while also investigating the
      prevalence of objective cognitive impairment in different EDSS strata of pwMS. MS patients
      will be stratified by EDSS to evaluate the correlation between objective and subjective
      cognition in three different EDSS strata (EDSS 0 - 2; 2.5 - 3.5; 4.0 - 5.5) and the
      occurrence of objective cognitive dysfunction in these EDSS stages of MS.

      All data will be captured using the icompanion app in a remote, non-clinical setting (i.e.,
      patient's home) within three weeks of patient onboarding. In the icompanion app, patients
      will be asked to perform the icognition cognitive test battery together with patient-reported
      outcomes (PROs) for subjective cognition, MS symptoms, prEDSS, depression and fatigue. If
      available, a recent (max. 6 months) MRI scan will be provided from which volumetric
      measurements can be calculated using icometrix' icobrain software.

      Finally, patients will be asked to answer questions on their experiences with cognition since
      diagnosis, their preferences and opinions about cognition as a treatment goal, and the
      usability of the icognition battery, and the preference compared to paper-based
      neuropsychological tests.
    

Intervention name(s): Custom study version of icompanion app
Intervention type(s): Other
Intervention description(s): Patients complete patient-reported outcomes on cognition and covariates, as well as objective cognitive tests through a version of icompanion app customized specifically for this study. Patients complete all assessments remotely in an at-home situation.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        300 CIS/RRMS patients, aged 18 to 65 (inclusive), with a maximum disease duration of 15
        years.
      
Keywords: Cognition