DreaMS - Digital Biomarkers for Multiple Sclerosis (DreaMS)

March 1, 2021 updated by: Research Center for Clinical Neuroimmunology and Neuroscience Basel

DreaMS - Development of Digital Biomarkers in Multiple Sclerosis - Feasibility Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with MS
30 Patients with MS will use the DreaMS App over a study duration of 6 weeks.
Device: DreaMS
The dreaMS App is a data communication platform collecting data from the patients' mobile devices (smartphone and wearables). We analyze app-based tests, surveys and sensor data.
Experimental: Healthy Volunteers
30 Healthy Volunteers will use the DreaMS App over a study duration of 6 weeks.
Device: DreaMS
The dreaMS App is a data communication platform collecting data from the patients' mobile devices (smartphone and wearables). We analyze app-based tests, surveys and sensor data.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Test Reliability of digital biomarkers measured by Intra Class Correlation
Time Frame: 6 weeks
Number of digital biomarkers tested with an Intra Class Correlation of at least 0.6 if repeated 10 times
6 weeks
Test Reliability of digital biomarkers measured by Coefficient of variation
Time Frame: 6 weeks
Number of digital biomarkers tested with a coefficient of Variation of less than 20% if repeated 10 times
6 weeks
Determination of user acceptance of each digital biomarker with regards to acceptance based on a questionnaire using a likert scale
Time Frame: 6 weeks
Number of digital biomarkers tested with a good acceptance reflected by a mean response of more than 3 on a likert scale.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Research Center for Clinical Neuroimmunology and Neuroscience Basel

Investigators

  • Principal Investigator: Ludwig Kappos, MD, University Hospital Basel and RC2NB

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2020

Primary Completion (Actual)

February 26, 2021

Study Completion (Actual)

February 26, 2021

Study Registration Dates

First Submitted

May 12, 2020

First Submitted That Met QC Criteria

May 29, 2020

First Posted (Actual)

June 2, 2020

Study Record Updates

Last Update Posted (Actual)

March 2, 2021

Last Update Submitted That Met QC Criteria

March 1, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DreaMS_2020F

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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