CogMS - A Real-world Study Into Cognitive Impairment in People With Multiple Sclerosis
NCT ID: NCT05671055
Last Updated: 2023-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
300 participants
OBSERVATIONAL
2023-01-07
2023-12-06
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Main arm
Use of icompanion through will all assessments are performed
Custom study version of icompanion app
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.
Interventions
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Custom study version of icompanion app
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.
Eligibility Criteria
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Inclusion Criteria
* Aged between 18 and 65 years old
* MS diagnosis (CIS, RRMS)
* Absence of hand function problems which limit the use of a device like a smartphone
* No history of relapse with onset 30 days prior to start of study
* No other major neurological or psychiatric disorders
* No history of cognitive rehabilitation treatment
Exclusion Criteria
* Patients with established cognitive disorders other than MS
* Drug and/or alcohol abuse
18 Years
65 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
icometrix
INDUSTRY
Responsible Party
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Principal Investigators
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Guy Nagels, Prof.
Role: PRINCIPAL_INVESTIGATOR
UZ Brussel - icometrix
Locations
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UCHealth
Aurora, Colorado, United States
Brain Health Center of the Rockies
Fort Collins, Colorado, United States
Dent Neurologic Institute
Buffalo, New York, United States
The Boster Center for Multiple Sclerosis
Columbus, Ohio, United States
Texas Neurology
Dallas, Texas, United States
GZA Antwerpen
Antwerp, , Belgium
Imelda Ziekenhuis
Bonheiden, , Belgium
AZ Sint-Jan Brugge
Bruges, , Belgium
UZ Brussel
Jette, , Belgium
University of Greifswald
Greifswald, , Germany
Countries
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Other Identifiers
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ICO-S-001
Identifier Type: -
Identifier Source: org_study_id