CogMS - A Real-world Study Into Cognitive Impairment in People With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 10
- 主要终点
- Neuro-QoL cognitive
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Disease duration longer than 15 years
- •Patients with established cognitive disorders other than MS
- •Drug and/or alcohol abuse
结局指标
主要结局
Neuro-QoL cognitive
时间窗: 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 Dot test score
时间窗: 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 Symbol test score
时间窗: 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 Digit test score
时间窗: 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.
次要结局
- 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))
- System usability score (cognitive smartphone-based tests)(Single cross-sectional time-point (max 2 months after signing ICF))
- prEDSS(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))
- Preference icognition vs. paper-based assessments(Single cross-sectional time-point (max 2 months after signing ICF))
- SymptoMScreen(Single cross-sectional time-point (max 2 months after signing ICF))