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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

Tracking Information
First Submitted Date  ICMJE May 12, 2020
First Posted Date  ICMJE June 2, 2020
Last Update Posted Date March 2, 2021
Actual Study Start Date  ICMJE October 5, 2020
Actual Primary Completion Date February 26, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2020)
  • 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
  • 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
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE DreaMS - Digital Biomarkers for Multiple Sclerosis
Official Title  ICMJE DreaMS - Development of Digital Biomarkers in Multiple Sclerosis - Feasibility Study
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Patients with MS
    30 Patients with MS will use the DreaMS App over a study duration of 6 weeks.
    Intervention: Device: DreaMS
  • Experimental: Healthy Volunteers
    30 Healthy Volunteers will use the DreaMS App over a study duration of 6 weeks.
    Intervention: Device: DreaMS
Publications * Woelfle T, Pless S, Reyes O, Wiencierz A, Feinstein A, Calabrese P, Gugleta K, Kappos L, Lorscheider J, Naegelin Y. Reliability and acceptance of dreaMS, a software application for people with multiple sclerosis: a feasibility study. J Neurol. 2023 Jan;270(1):262-271. doi: 10.1007/s00415-022-11306-5. Epub 2022 Aug 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 30, 2020)		 62
Original Estimated Enrollment  ICMJE
 (submitted: May 29, 2020)		 60
Actual Study Completion Date  ICMJE February 26, 2021
Actual Primary Completion Date February 26, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04413032
Other Study ID Numbers  ICMJE DreaMS_2020F
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Research Center for Clinical Neuroimmunology and Neuroscience Basel
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Research Center for Clinical Neuroimmunology and Neuroscience Basel
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ludwig Kappos, MD University Hospital Basel and RC2NB
PRS Account Research Center for Clinical Neuroimmunology and Neuroscience Basel
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP