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DreaMS - Digital Biomarkers for Multiple Sclerosis (DreaMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04413032
Recruitment Status : Completed
First Posted : June 2, 2020
Last Update Posted : March 2, 2021
Sponsor:
Information provided by (Responsible Party):
Research Center for Clinical Neuroimmunology and Neuroscience Basel

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Device: DreaMS Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A group of patients with Multiple Sclerosis and a group of healthy volunteers will use the dreaMS App over the period of 6 weeks.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: DreaMS - Development of Digital Biomarkers in Multiple Sclerosis - Feasibility Study
Actual Study Start Date : October 5, 2020
Actual Primary Completion Date : February 26, 2021
Actual Study Completion Date : February 26, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04413032


Locations
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Switzerland
RC2NB
Basel, Switzerland, 4031
Sponsors and Collaborators
Research Center for Clinical Neuroimmunology and Neuroscience Basel
Investigators
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Principal Investigator: Ludwig Kappos, MD University Hospital Basel and RC2NB
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Research Center for Clinical Neuroimmunology and Neuroscience Basel
ClinicalTrials.gov Identifier: NCT04413032    
Other Study ID Numbers: DreaMS_2020F
First Posted: June 2, 2020    Key Record Dates
Last Update Posted: March 2, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases