DreaMS - Development of Digital Biomarkers in Multiple Sclerosis - Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Test Reliability of digital biomarkers measured by Coefficient of variation
研究概览
简要总结
The Investigators have developed the dreaMS App, a data communication platform collecting data from the patients' mobile devices (smartphone and wearables). Through the use of app-based tests, surveys and sensor data, the Investigators aim to identify novel types of clinical data that can be used as digital biomarkers with complementary clinical value as compared to the traditional diagnostic methods and techniques.
In this feasibility study a number of digital biomarkers will be applied to test their technical reproducibility/stability and meaningfulness to patients.
详细描述
Multiple Sclerosis (MS) is a chronic inflammatory disease of the central nervous system (CNS) causing focal lesions of demyelination and diffuse neurodegeneration in the grey and white matter of the brain and spinal cord, leading to physical and cognitive disability. Currently there is a limited number of relevant biomarkers available in patients with MS, such as clinical, imaging or biological measures. Patient history and neurologic examination in combination with magnetic resonance imaging (MRI), evoked potentials and analysis of serum and cerebrospinal fluid (CSF) are the gold standard of diagnosis and mainly patient history, neurologic examination and MRI are used for patient monitoring. However, their prognostic value on a patient level is still very limited. Therefore, the scientific community and patients are in need for new and more reliable biomarkers, especially biomarkers of disease progression in order to adapt therapeutic approaches on an individual level. Digital biomarkers have the potential to fill this gap allowing for quasi-continuous measures that might be more informative than episodically collected conventional data concerning the impact of the disease on activities of daily living.
The Investigators have developed the dreaMS App, a data communication platform collecting data from the patients' mobile devices (smartphone and wearables). Through the use of app-based tests, surveys and sensor data, the Investigators aim to identify novel types of clinical data that can be used as digital biomarkers with complementary clinical value as compared to the traditional diagnostic methods and techniques.
In this feasibility study a number of digital biomarkers will be applied to test their technical reproducibility/stability and meaningfulness to patients and to select the most informative for the planned validation study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with MS
- •Inclusion Criteria:
- •Age 18-70
- •Diagnosed with MS according to the revised McDonald criteria 2017, all clinical forms inclusive (CIS, RRMS, SPMS, PPMS)
- •EDSS ≤ 6.5
- •In possession of a smart phone
排除标准
- •Age <18 and > 70
- •EDSS > 6.5
- •Other clinically significant concomitant disease states (e.g., renal failure, severe hepatic dysfunction, severe/unstable cardiovascular disease, progressive cancer, etc.)
- •Known or suspected non-compliance, drug or alcohol abuse
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
- •Women who are pregnant or breast feeding
- •Not in possession of a smart phone
- •Healthy Volunteers
- •Inclusion Criteria:
- •Age 18-70
- •In possession of a smart phone
- •Exclusion Criteria:
- •Age <18 and > 70
- •Diagnosis of MS
- •Clinically significant concomitant disease states (e.g., renal failure, severe hepatic dysfunction, severe/unstable cardiovascular disease, progressive cancer, etc.)
- •Known or suspected non-compliance, drug or alcohol abuse
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
- •Women who are pregnant or breast feeding
- •Not in possession of a smart phone
结局指标
主要结局
Test Reliability of digital biomarkers measured by Coefficient of variation
时间窗: 6 weeks
Number of digital biomarkers tested with a coefficient of Variation of less than 20% if repeated 10 times
Test Reliability of digital biomarkers measured by Intra Class Correlation
时间窗: 6 weeks
Number of digital biomarkers tested with an Intra Class Correlation of at least 0.6 if repeated 10 times
Determination of user acceptance of each digital biomarker with regards to acceptance based on a questionnaire using a likert scale
时间窗: 6 weeks
Number of digital biomarkers tested with a good acceptance reflected by a mean response of more than 3 on a likert scale.
次要结局
未报告次要终点