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History of Changes for Study: NCT05009160
DreaMS - Validation Study 1
Latest version (submitted June 9, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 16, 2021 None (earliest Version on record)
2 September 10, 2021 Groups and Interventions, Study Status, Contacts/Locations, Outcome Measures and Oversight
3 December 28, 2021 Study Status and Oversight
4 June 9, 2022 Recruitment Status, Study Status, Contacts/Locations, Groups and Interventions, Eligibility, Study Design, Study Description and Study Identification
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Study NCT05009160
Submitted Date:  August 16, 2021 (v1)

Open or close this module Study Identification
Unique Protocol ID: DreaMS_2021VS1
Brief Title: DreaMS - Validation Study 1
Official Title: DreaMS - Development of Digital Biomarkers in Multiple Sclerosis - Validation Study 1
Secondary IDs:
Open or close this module Study Status
Record Verification: August 2021
Overall Status: Not yet recruiting
Study Start: October 2021
Primary Completion: April 2025 [Anticipated]
Study Completion: April 2025 [Anticipated]
First Submitted: July 23, 2021
First Submitted that
Met QC Criteria:
August 16, 2021
First Posted: August 17, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
August 16, 2021
Last Update Posted: August 17, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Research Center for Clinical Neuroimmunology and Neuroscience Basel
Responsible Party: Sponsor
Collaborators: Healios AG
University Hospital, Basel, Switzerland
University of Basel
Innosuisse - Swiss Innovation Agency
Novartis Pharmaceuticals
Hoffmann-La Roche
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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 dreaMS App, a data collection, communication and management platform using data collected through the patients' mobile devices (smartphone and wearables). 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.

Open or close this module Conditions
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Digital Biomarker
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Case-Control
Time Perspective: Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 450 [Anticipated]
Number of Groups/Cohorts 2
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
Patients with Multiple Sclerosis (PwMS)
PwMS will download the dreaMS App and will follow the study schedule.
Device: dreaMS App R2.0
dreaMS App will be downloaded by all participants and all participants (PwMS and HC) will follow the same schedule
Healthy Control Persons (HC)
HC will download the dreaMS App and will follow the same study schedule as PwMS.
Device: dreaMS App R2.0
dreaMS App will be downloaded by all participants and all participants (PwMS and HC) will follow the same schedule
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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).
2. 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).
Open or close this module Eligibility
Study Population: Participants of this study will be recruited from the outpatient department of the MS Center Basel at the University Hospital Basel.
Sampling Method: Non-Probability Sample
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
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 DreaMS 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
Open or close this module Contacts/Locations
Central Contact Person: Yvonne Naegelin
Telephone: +41613285306
Email: yvonne.naegelin@usb.ch
Central Contact Backup: Johannes Lorscheider
Telephone: +41615565796
Email: johannes.lorscheider@usb.ch
Study Officials: Ludwig Kappos
Principal Investigator
Research Center for Clinical Neuroimmunology and Neuroscience Basel
Yvonne Naegelin
Principal Investigator
RC2NB and Department of Neurology, University Hospital of Basel, Switzerland
Johannes Lorscheider
Principal Investigator
RC2NB and Department of Neurology, University Hospital of Basel, Switzerland
Locations:
Open or close this module IPDSharing
Plan to Share IPD: Undecided
Open or close this module References
Citations:
Links:
Available IPD/Information:

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