MS-DETECT: Early Detection of Multiple Sclerosis Progression With MSCopilot® Detect
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Ad scientiam
- 入组人数
- 336
- 试验地点
- 46
- 主要终点
- To evaluate MSCopilot® Detect individual scores and/or composite scores sensitivity to detect disability worsening based on revised-MSFC scores.
研究概览
简要总结
The study aims to evaluate MSCopilot® Detect, a smartphone application for at-home monitoring of patients with Multiple Sclerosis (MS).
The primary objective is to enhance and standardize remote monitoring of MS patients to accurately assess disease progression caused by either Relapse Activity Worsening (RAW) or Progression Independent of Relapses (PIRA). The study also aims to assess the safety, usability, and satisfaction of the solution.
A secondary objective is to determine MSCopilot® Detect's ability to provide early detection of disease changes and predict changes in Expanded Disability Status Scale (EDSS) scores in more patients.
Exploratory objectives include evaluating the relationship between MSCopilot® Detect composite and individual scores and other biomarkers such as MRI, soluble glial fibrillary acidic protein (sGFAP), and soluble neurofilament light chain (sNfL).
Patients will be able to download the free MSCopilot® Detect app. They will participate in 1 inclusion visit and 3 follow-up visits, scheduled at 6 months, 12 months, and 18 months (an additional visit at 24 months may be scheduled if necessary). Every 3 months, patients will complete validated questionnaires regarding MS symptoms and quality of life and participate in digital tests designed to monitor MS symptom progression.
The study will include 336 MS patients and will be conducted in the United States, Canada, Germany, Italy, Spain, Denmark and France
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients living with RRMS or SPMS, aged 30 to 65
- •EDSS score between 2.5 to 6.5 points
- •With a disease duration > 5 years
- •Clinically stable during the last 3 months before inclusion (no relapses, no disability progression)
- •No change in the DMT* during the last 3 months before inclusion
- •Receiving optimal symptomatic treatments at baseline (clinician's judgment)
- •Owns a personal smartphone which mobile operating system is above 14 for IOS (iPhone) and 8 for Android included with a good internet connexion
- •Able to use a smartphone
- •Able to read language in wich the mobile application is available and able to understand pictograms.
- •Applicable to patients enrolled in France only: affiliated to a social security system.
排除标准
- •Medically unstable conditions that may hinder patient's ability to comply with the study procedures
- •Inability to use a smartphone or MSCopilot® Detect application
- •Patient with corrected visual acuity less than 4/10 (Monoyer) or 20/50 (Snellen at 20 feet) or +0,4 (LogMAR)
- •Pregnancy and nursing women
- •Persons under guardianship or curatorship
- •Current drugs or/and alcohol abuse that could influence performance on the tests (clinician's judgment)
- •Patients have participated in another clinical study within the previous 30 days of screening or are currently participating in another study that, in the opinion of the Investigator, might interfere with the patient's full participation in the study or confound the assessment of the patient or outcome of the study.
研究组 & 干预措施
MSCopilot® Detect
Performance of digital tests and standard test in clinic at D0, M6, M12, M18 and M24 (if applicable) Use of MSCopilot® Detect at-home in between visits during 18 or 24 months (if applicable)
干预措施: MSCopilot® Detect mobile application (Device)
结局指标
主要结局
To evaluate MSCopilot® Detect individual scores and/or composite scores sensitivity to detect disability worsening based on revised-MSFC scores.
时间窗: Throughout the study at each hospital visit: Day 0, Month 6, Month 12, Month 18 and Month 24 (if applicable)
The discriminatory ability of the MSCopilot® Detect application in detecting clinically meaningful worsening (disability worsening) based on the revised-MSFC will be evaluated using the Area Under the ROC Curve (AUC) method. Confidence intervals will also be estimated. The minimum significant AUC value will be set at \>0.67, and Confidence Intervals will be calculated. Sensitivity and specificity will also be determined. To validate the estimated AUC values and cutoffs generated by the MSCopilot® Detect application, a train/test set will be utilised.
次要结局
- To evaluate MSCopilot® Detect individual and/or composite scores ability to detect disease progression in absence of a relapsing activity (PIRA).(Throughout the study at each hospital visit: Day 0, Month 6, Month 12, Month 18 and Month 24 (if applicable))
- To assess reliability of MSCopilot® Detect individual scores and/or composite scores at-home over time.(Day 0 versus Month 6, Month 6 versus Month 12, Month 12 versus Month 18, Month18 versus Month 24 (if applicable) AND Day 0 to Month 18 or Day 0 to Month 24 (if applicable) and Day 0 to Month 15 or Day 0 to Month 21 (if applicable) at home.)
- To evaluate MSCopilot® Detect individual scores and/or composite scores sensitivity to detect disability worsening based on EDSS.(Throughout the study at each hospital visit: Day 0, Month 6, Month 12, Month 18 and Month 24 (if applicable))
- To evaluate MSCopilot® Detect individual scores and/or composite scores sensitivity to detect disability worsening earlier than the EDSS.(Throughout the study at each hospital visit: Day 0, Month 6, Month 12, Month 18 and Month 24 (if applicable))
- To assess the satisfaction and user experience with the MSCopilot® Detect web dashboard.(Every 6 months for about 24 months)
- To measure MSCopilot® Detect individual scores and/or composite scores association with the clinical scores.(Throughout the study at each hospital visit: Day 0, Month 6, Month 12, Month 18 and Month 24 (if applicable))
- To evaluate Patient QoL (Multiple Sclerosis Impact Scale: MSIS-29 and Modified Fatigue Impact Scale - 5-item version: MFIS-5) and their association with MSCopilot® Detect individual and composite scores.(Throughout the study between in clinic visit, an average of 24 months)
- To evaluate MSCopilot® Detect Adherence(Throughout the study between in clinic visit, an average of 24 months)
- To evaluate MSCopilot® Detect individual scores and/or composite scores ability to detect MSFC changes over time.(Throughout the study at each hospital visit: Day 0, Month 6, Month 12, Month 18 and Month 24 (if applicable))
- To assess reproducibility of MSCopilot® Detect individual scores and/or composite scores between in-clinic and at-home digital tests.(At home (Day 1, Month 6+1 day, Month 12 + 1 day, Month 18-1 day and Month 24-1 day (if applicable)) and in-clinic ((Day 0, Month 6, Month 12, Month 18 and Month 24 (if applicable)))
- To assess the satisfaction and user experience with the MSCopilot® Detect smartphone application and the MSCopilot® Detect web dashboard.(Every 3 months for about 24 months)
- To describe the evolution of MSCopilot® Detect individual scores and/or composite scores at-home over time.(Throughout the study between in clinic visit, an average of 24 months)
- To evaluate the ability of MSCopilot® Detect individual scores and/or composite score to discriminate between a relapse and a momentary disability worsening (+1 point EDSS score for an initial EDSS <5,5; +0.5 point for an initial EDSS ≥5.5).(Throughout the study at each hospital visit: Day 0, Month 6, Month 12, Month 18 and Month 24 (if applicable))
- To evaluate MSCopilot® Detect Safety(Throughout the study between in clinic visit, an average of 24 months)