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DreaMS - Validation Study 1

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05009160
Recruitment Status : Recruiting
First Posted : August 17, 2021
Last Update Posted : June 13, 2022
Sponsor:
Collaborators:
Healios AG
University Hospital, Basel, Switzerland
University of Basel
Innosuisse - Swiss Innovation Agency
Novartis Pharmaceuticals
Hoffmann-La Roche
Information provided by (Responsible Party):
Research Center for Clinical Neuroimmunology and Neuroscience Basel

Tracking Information
First Submitted Date July 23, 2021
First Posted Date August 17, 2021
Last Update Posted Date June 13, 2022
Actual Study Start Date March 30, 2022
Estimated Primary Completion Date April 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 10, 2021)
  • Correlation of the digital features with the respective measurements of the clinical reference tests [ Time Frame: Baseline to last visit (year two) ]
    Spearman correlation coefficients higher than 0.4 (lower bound of 95% confidence interval) are considered relevant. All scheduled pairs of measurements collected during the study will be used. As the yearly observations of a patient are not independent, standard confidence intervals cannot be used. Therefore, a bootstrap approach will be used to determine a 95% confidence interval for the Spearman correlations (where data will be resampled on the patient level).
  • The ability of measurements of the changes in the digital biomarkers over the two-year follow-up to predict worsening in the clinical reference test over the same period expressed as binary variables [ Time Frame: Measurements at baseline and after two years ]
    The change of the digital biomarker over two years allows to distinguish patients experiencing a relevant worsening in the corresponding reference test over the same period from those who do not with an area under the receiver operating characteristic curve (AUC) larger than 0.6 (lower bound of 95% confidence interval).
Original Primary Outcome Measures
 (submitted: August 16, 2021)
  • Correlation of the digital features with the respective measurements of the clinical reference tests [ Time Frame: Baseline to last visit (year two) ]
    Spearman correlation coefficients higher than 0.4 (lower bound of 95% confidence interval) are considered relevant. All scheduled pairs of measurements collected during the study will be used. As the yearly observations of a patient are not independent, standard confidence intervals cannot be used. Therefore, a bootstrap approach will be used to determine a 95% confidence interval for the Spearman correlations (where data will be resampled on the patient level).
  • The ability of measurements of the changes in the digital biomarkers over the two-year follow-up to predict worsening in the clinical reference test over the same period expressed as binary variables [ Time Frame: Measurements at baseline and after two years ]
    The change of the digital biomarker over two years allows to distinguish patients experiencing a relevant worsening in the corresponding reference test over the same period from those who do not with an area under the receiver operating characteristic curve (AUC) larger than 0.7 (lower bound of 95% confidence interval).
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title DreaMS - Validation Study 1
Official Title DreaMS - Development of Digital Biomarkers in Multiple Sclerosis - Validation Study 1
Brief Summary

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. 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.

Using app-based challenges, continuous monitoring and surveys the Investigators aim to obtain data that can be used as digital biomarkers (DB). These digital biomarkers will provide more granular and precise assessments, thus complementing traditional diagnostic measures and techniques. After a first feasibility study (ClinicalTrials.gov: NCT04413032) a number of digital biomarkers have been identified as reliable, reproducible and meaningful to PwMS and are therefore being validated in a bigger cohort of PwMS with a longer follow-up within this validation study 1. Those digital biomarkers will be compared to state-of-the-Art clinical, imaging and body fluid assessment.
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 persons with MS (PwMS), 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 Healios+Me platform App which contains the dreaMS App and serves as a data collection, communication and management platform using data collected through the patients' mobile devices (smartphone and wearables). Using the dreaMS app-based challenges, continuous monitoring and surveys the Investigators aim to obtain data that can be used as digital biomarkers (DB). These digital biomarkers will provide more granular and precise assessments, thus complementing traditional diagnostic measures and techniques. After a first feasibility study (ClinicalTrials.gov: NCT04413032) a number of digital biomarkers have been identified as reliable, reproducible and meaningful to PwMS and are therefore being validated in a bigger cohort of PwMS with a longer follow-up within this validation study 1. Those digital biomarkers will be compared to state-of-the-Art clinical, imaging and body fluid assessment.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Participants of this study will be recruited from the outpatient department of the MS Center Basel at the University Hospital Basel.
Condition Multiple Sclerosis
Intervention Device: dreaMS App R2.1
The Healios+Me platform App which contains the dreaMS App will be downloaded by all participants and all participants (PwMS and HC) will follow the same schedule
Study Groups/Cohorts
  • Patients with Multiple Sclerosis (PwMS)
    PwMS will download the Healios+Me platform App which contains the dreaMS App and will follow the study schedule.
    Intervention: Device: dreaMS App R2.1
  • Healthy Control Persons (HC)
    HC will download the Healios+Me platform App which contains the dreaMS App and will follow the same study schedule as PwMS.
    Intervention: Device: dreaMS App R2.1
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 16, 2021)		 450
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 2025
Estimated Primary Completion Date April 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Age ≥18
  • Diagnosed with MS according to the revised McDonald criteria 2017, all clinical forms inclusive (CIS, RRMS, SPMS, PPMS), for PwMS only
  • In possession of a Healios+Me App compatible smartphone (iOS/Android)
  • Corrected close visual acuity of ≥0.5
  • Hand motor skills sufficient for using a smartphone
  • Ability to follow the study procedures
  • Informed Consent as documented by signature

Exclusion Criteria:

  • Being diagnosed with MS or other disease affecting neurological and cognitive functions, for HC only
  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Johannes Lorscheider +41615565796 johannes.lorscheider@usb.ch
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT05009160
Other Study ID Numbers DreaMS_2021VS1
SNCTP000004678 ( Registry Identifier: Swiss National Clinical Trials Portal )
Has Data Monitoring Committee No
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
Plan to Share IPD: Undecided
Current Responsible Party Research Center for Clinical Neuroimmunology and Neuroscience Basel
Original Responsible Party Same as current
Current Study Sponsor Research Center for Clinical Neuroimmunology and Neuroscience Basel
Original Study Sponsor Same as current
Collaborators
  • Healios AG
  • University Hospital, Basel, Switzerland
  • University of Basel
  • Innosuisse - Swiss Innovation Agency
  • Novartis Pharmaceuticals
  • Hoffmann-La Roche
Investigators
Study Director: Ludwig Kappos Research Center for Clinical Neuroimmunology and Neuroscience Basel
Principal Investigator: Johannes Lorscheider RC2NB and Department of Neurology, University Hospital of Basel, Switzerland
PRS Account Research Center for Clinical Neuroimmunology and Neuroscience Basel
Verification Date June 2022