CogMS - A Real-world Study Into Cognitive Impairment in People With Multiple Sclerosis

NCT05671055 | Completed

• 1 other identifier: ICO-S-001
• Study Type: observational
• Target: 300
• Locations: 3 countries
• Sites: 10

Brief 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.

Conditions

Multiple Sclerosis

Keywords

Cognition

Outcome Measures

Primary Outcomes (4)

• Neuro-QoL cognitive

  The Neuro-QoL (Quality of Life in Neurological Disorders) is a patient-reported outcome for subjective cognitive problems Minimum and maximum values: 8-40 (t-score: 17.3-64.2). High scores indicate better (desirable) self-reported health.

  Single cross-sectional time-point (max 2 months after signing ICF)

• icognition Symbol test score

  The icognition Symbol test is a smartphone-based symbol substitution test for information processing speed Minimum and maximum values: to be determined by a separate study which is being finalised High scores indicate better (desirable) self-reported health.

  Single cross-sectional time-point (max 2 months after signing ICF)

• icognition Dot test score

  The icognition Dot test score is a smartphone-based test for visual working memory Minimum and maximum values: to be determined by a separate study which is being finalised High scores indicate better (desirable) self-reported health.

  Single cross-sectional time-point (max 2 months after signing ICF)

• icognition Digit test score

  The icognition Digit test score is a smartphone-based test for working memory Minimum and maximum values: to be determined by a separate study which is being finalised High scores indicate better (desirable) self-reported health.

  Single cross-sectional time-point (max 2 months after signing ICF)

Secondary Outcomes (7)

• prEDSS

  Single cross-sectional time-point (max 2 months after signing ICF)

• Neuro-QoL fatigue

  Single cross-sectional time-point (max 2 months after signing ICF)

• Beck's depression inventory

  Single cross-sectional time-point (max 2 months after signing ICF)

• MRI volumetric variables

  at time of enrolment in study (in case MRI of <6months is available)

• System usability score (cognitive smartphone-based tests)

  Single cross-sectional time-point (max 2 months after signing ICF)

Study Arms (1)

Main arm

Use of icompanion through will all assessments are performed

Other: Custom study version of icompanion app

Interventions

Custom study version of icompanion app OTHER

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.

Main arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

300 CIS/RRMS patients, aged 18 to 65 (inclusive), with a maximum disease duration of 15 years.

You may qualify if:

• Providing a signed informed consent
• 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

You may not qualify if:

• Disease duration longer than 15 years
• Patients with established cognitive disorders other than MS
• Drug and/or alcohol abuse

Sponsors & Collaborators

• icometrix: lead
• Bristol-Myers Squibb: collaborator

Study Sites (10)

UCHealth

Aurora, Colorado, 80045, United States

Location

Brain Health Center of the Rockies

Fort Collins, Colorado, 80528, United States

Location

Dent Neurologic Institute

Buffalo, New York, 14226, United States

Location

The Boster Center for Multiple Sclerosis

Columbus, Ohio, 43235, United States

Location

Texas Neurology

Dallas, Texas, 75206, United States

Location

GZA Antwerpen

Antwerp, 2018, Belgium

Location

Imelda Ziekenhuis

Bonheiden, 2820, Belgium

Location

AZ Sint-Jan Brugge

Bruges, 8000, Belgium

Location

UZ Brussel

Jette, 1090, Belgium

Location

University of Greifswald

Greifswald, 17489, Germany

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

• Guy Nagels, Prof.

  UZ Brussel - icometrix

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: January 4, 2023
• Study Start: January 7, 2023
• Primary Completion: December 6, 2023
• Study Completion: December 6, 2023
• Last Updated: December 7, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); BE (4); US (5)