CompletedNot a drug-phase studyRelapsing and progressiveNCT04413032

What it found

Result in a paper, not read yet

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • DreaMS

What it measured

Main measures

  • Test Reliability of digital biomarkers measured by Intra Class Correlation

    6 weeks

    Blood or spinal fluid markers
  • Test Reliability of digital biomarkers measured by Coefficient of variation

    6 weeks

    Blood or spinal fluid markers
  • Determination of user acceptance of each digital biomarker with regards to acceptance based on a questionnaire using a likert scale

    6 weeks

    Blood or spinal fluid markers

Who could take part

Relapsing and progressive · 18 to 70

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 Exclusion Criteria: * 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

Loading reviews and guidelines…

Linked trials

Links found where a registry record names another trial's registry number.

History

    1. Started

      Oct 2020

    2. Main results due

      Feb 2021

    3. Finished

      Feb 2021

    Assembled by software from public sources and not checked by people. Each record links to its source. Report an error