DreaMS - Validation Study 1

Last updated: March 27, 2025
Sponsor: Research Center for Clinical Neuroimmunology and Neuroscience Basel
Overall Status: Active - Recruiting

Phase

N/A

Condition

Multiple Sclerosis

Memory Loss

Neurologic Disorders

Treatment

dreaMS App R2.1

Clinical Study ID

NCT05009160
DreaMS_2021VS1
SNCTP000004678
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥18

  • Diagnosed with MS according to the revised McDonald criteria 2017, all clinicalforms 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

Exclusion Criteria:

  • Being diagnosed with MS or other disease affecting neurological and cognitivefunctions, for HC only

  • Other clinically significant concomitant disease states (e.g., renal failure, severehepatic dysfunction, severe/unstable cardiovascular disease, progressive cancer,etc.)

  • Known or suspected non-compliance, drug or alcohol abuse

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: dreaMS App R2.1
Phase:
Study Start date:
March 30, 2022
Estimated Completion Date:
March 31, 2027

Study 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.

Connect with a study center

  • Neurozentrum, Kantonsspital Aarau

    Aarau,
    Switzerland

    Active - Recruiting

  • MS Center, Department of Neurology University Hospital Basel

    Basel,
    Switzerland

    Active - Recruiting

  • Department of Neurology, CHUV Lausanne

    Lausanne,
    Switzerland

    Active - Recruiting

  • Centro Sclerosi Multipla, Ospedale Regionale di Lugano

    Lugano,
    Switzerland

    Active - Recruiting

  • Klinik für Neurologie, Kantonsspital St. Gallen

    St.Gallen,
    Switzerland

    Active - Recruiting

  • Klinik für Neurologie, Universitätsspital Zürich

    Zürich,
    Switzerland

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.