Multiple SclerosisNCT05671055
CogMS - A Real-world Study Into Cognitive Impairment in People With Multiple Sclerosis
An observational study of Multiple Sclerosis, run by icometrix at 10 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Custom study version of icompanion app
- How many people
- 300 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 7 Jan 2023to 6 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 300 CIS/RRMS patients, aged 18 to 65 (inclusive), with a maximum disease duration of 15 years.
Who may be able to join
- 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
Who cannot join
- Disease duration longer than 15 years
- Patients with established cognitive disorders other than MS
- Drug and/or alcohol abuse
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
United States5 sites
UCHealth
Aurora, Colorado, 80045
Dent Neurologic Institute
Buffalo, New York, 14226
The Boster Center for Multiple Sclerosis
Columbus, Ohio, 43235
Texas Neurology
Dallas, Texas, 75206
Brain Health Center of the Rockies
Fort Collins, Colorado, 80528
Belgium4 sites
GZA Antwerpen
Antwerp, 2018
Imelda Ziekenhuis
Bonheiden, 2820
AZ Sint-Jan Brugge
Bruges, 8000
UZ Brussel
Jette, 1090
About this study
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Custom study version of icompanion app
- Keywords
- Cognition
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Custom study version of icompanion appOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Main arm | Use of icompanion through will all assessments are performed Receives: Other: Custom study version of icompanion app |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Single cross-sectional time-point (max 2 months after signing ICF)
Secondary outcomes (7)
prEDSS
is a patient-reported outcome (PRO) version of the Expanded Disability Status Scale (EDSS), the current golden standard method for assessing disability (progression) in MS.
Minimum and maximum values: 0-10 Low scores indicate better (desirable) self-reported health.
Measured: Single cross-sectional time-point (max 2 months after signing ICF)
Neuro-QoL fatigue
Neuro-QoL Fatigue is a patient-reported outcome for fatigue Minimum and maximum values: 8-40 (t-score: 29.5-74.1). Low scores indicate better (desirable) self-reported health.
Measured: Single cross-sectional time-point (max 2 months after signing ICF)
Beck's depression inventory
The BDI is a 21-question multiple-choice self-report psychometric tests for measuring the severity of depression.
Minimum and maximum values: 0-63. Low scores indicate better (desirable) self-reported health.
Measured: Single cross-sectional time-point (max 2 months after signing ICF)
MRI volumetric variables
icobrain volumetric MRI measurements: whole brain volume and atrophy, grey matter volume and atrophy, lesion load, total lesion volume, volume of new lesions, volume of enlarging lesions, volume of shrinking lesions, lesion volume and volume changes assessed locally (i.e. juxtacortical, periventricular, deep white matter, infratentorial)
Measured: at time of enrolment in study (in case MRI of <6months is available)
System usability score (cognitive smartphone-based tests)
Usability questionnaire
Measured: Single cross-sectional time-point (max 2 months after signing ICF)
Preference icognition vs. paper-based assessments
Likert scale [0-5]
Measured: Single cross-sectional time-point (max 2 months after signing ICF)
SymptoMScreen
Questionnaire assessing the severity of the twelve most common MS Symptoms Minimum and maximum values: 0-6 Low scores indicate better (desirable) self-reported health.
Measured: Single cross-sectional time-point (max 2 months after signing ICF)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start7 Jan 2023
- Primary completion6 Dec 2023
- Study completion6 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- icometrix
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Guy Nagels, Prof., Principal investigator, UZ Brussel - icometrix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05671055
- Sponsor's protocol ID
- ICO-S-001
- Status last verified
- Dec 2023
- First submitted
- 28 Nov 2022
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CogMS - A Real-world Study Into Cognitive Impairment in People With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05671055
- Acronym / sponsor ID
- ICO-S-001
- Conditions
- Multiple Sclerosis
- Keywords
- Cognition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- icometrixIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- 7 Jan 2023 (actual)
- Primary completion
- 6 Dec 2023 (actual)
- Study completion
- 6 Dec 2023 (actual)
- First posted
- 4 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main arm | – | Other: Custom study version of icompanion appUse of icompanion through will all assessments are performed |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 300 CIS/RRMS patients, aged 18 to 65 (inclusive), with a maximum disease duration of 15 years.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- Disease duration longer than 15 years
- Patients with established cognitive disorders other than MS
- Drug and/or alcohol abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Custom study version of icompanion appPatients 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. | Other | Main arm |
Primary outcome
Neuro-QoL cognitive
Time frame: Single cross-sectional time-point (max 2 months after signing ICF)
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.
icognition Symbol test score
Time frame: Single cross-sectional time-point (max 2 months after signing ICF)
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.
icognition Dot test score
Time frame: Single cross-sectional time-point (max 2 months after signing ICF)
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.
icognition Digit test score
Time frame: Single cross-sectional time-point (max 2 months after signing ICF)
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.
7 secondary outcomes
prEDSS
Time frame: Single cross-sectional time-point (max 2 months after signing ICF)
Neuro-QoL fatigue
Time frame: Single cross-sectional time-point (max 2 months after signing ICF)
Beck's depression inventory
Time frame: Single cross-sectional time-point (max 2 months after signing ICF)
MRI volumetric variables
Time frame: at time of enrolment in study (in case MRI of <6months is available)
System usability score (cognitive smartphone-based tests)
Time frame: Single cross-sectional time-point (max 2 months after signing ICF)
Preference icognition vs. paper-based assessments
Time frame: Single cross-sectional time-point (max 2 months after signing ICF)
SymptoMScreen
Time frame: Single cross-sectional time-point (max 2 months after signing ICF)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guy Nagels, Prof. principal investigator
UZ Brussel - icometrix
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by icometrix at 10 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Belgium, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuro-QoL cognitive (time frame: Single cross-sectional time-point (max 2 months after signing ICF)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2023.