Multiple SclerosisNCT05009160
DreaMS - Validation Study 1
An observational study of Multiple Sclerosis, run by Research Center for Clinical Neuroimmunology and Neuroscience Basel at 6 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- dreaMS App R2.1
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 6 sitesSwitzerland
- Study dates
- 30 Mar 2022to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants of this study will be recruited from the outpatient department of the MS Center Basel at the University Hospital Basel.
Who may be able to join
- 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 Indivi 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Switzerland6 sites
Neurozentrum, Kantonsspital Aarau
Aarau, Switzerland
MS Center, Department of Neurology University Hospital Basel
Basel
Department of Neurology, CHUV Lausanne
Lausanne, Switzerland
Centro Sclerosi Multipla, Ospedale Regionale di Lugano
Lugano, Switzerland
Klinik für Neurologie, Kantonsspital St. Gallen
Sankt Gallen, Switzerland
Klinik für Neurologie, Universitätsspital Zürich
Zurich, Switzerland
About this study
Official title: DreaMS - Development of Digital Biomarkers in Multiple Sclerosis - Validation Study 1
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 persons with MS (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.
Read the 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 Indivi 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.
- Conditions
- Multiple Sclerosis
- Being tested
- dreaMS App R2.1
- Keywords
- Multiple Sclerosis, Digital Biomarker
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dreaMS App R2.1Device
The Indivi 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 group | Role | What they receive |
|---|---|---|
| Patients with Multiple Sclerosis (PwMS) | PwMS will download the Indivi platform App which contains the dreaMS App and will follow the study schedule. Receives: Device: dreaMS App R2.1 | |
| Healthy Control Persons (HC) | HC will download the Indivi platform App which contains the dreaMS App and will follow the same study schedule as PwMS. Receives: Device: dreaMS App R2.1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of the digital features with the respective measurements of the clinical reference tests
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).
Measured: Baseline to last visit (year two)
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
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).
Measured: Measurements at baseline and after two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start30 Mar 2022
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Research Center for Clinical Neuroimmunology and Neuroscience Basel
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Basel, Switzerland, University of Basel, Innosuisse - Swiss Innovation Agency, Novartis Pharmaceuticals, Hoffmann-La Roche, Indivi AG
- Responsible party
- Sponsor
- Investigators
- Ludwig Kappos, Study director, Research Center for Clinical Neuroimmunology and Neuroscience BaselJannis Müller, Principal investigator, RC2NB and Department of Neurology, University Hospital of Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05009160
- Sponsor's protocol ID
- DreaMS_2021VS1
- Other IDs
- SNCTP000004678
- Status last verified
- Feb 2026
- First submitted
- 23 Jul 2021
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DreaMS - Development of Digital Biomarkers in Multiple Sclerosis - Validation Study 1
- ClinicalTrials.gov ID
- NCT05009160
- Acronym / sponsor ID
- DreaMS_2021VS1
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Digital Biomarker
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Research Center for Clinical Neuroimmunology and Neuroscience BaselUniversity, hospital or other
- Collaborators
- University Hospital, Basel, Switzerland, University of Basel, Innosuisse - Swiss Innovation Agency, Novartis Pharmaceuticals, Hoffmann-La Roche, Indivi AG
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 17 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 persons with MS (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 Indivi 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Multiple Sclerosis (PwMS) | – | Device: dreaMS App R2.1PwMS will download the Indivi platform App which contains the dreaMS App and will follow the study schedule. |
| Healthy Control Persons (HC) | – | Device: dreaMS App R2.1HC will download the Indivi platform App which contains the dreaMS App and will follow the same study schedule as PwMS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants of this study will be recruited from the outpatient department of the MS Center Basel at the University Hospital Basel.
Key inclusion criteria (7 listed)
- 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 Indivi App compatible smartphone (iOS/Android)
- Corrected close visual acuity of ≥0.5
- Hand motor skills sufficient for using a smartphone
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dreaMS App R2.1The Indivi platform App which contains the dreaMS App will be downloaded by all participants and all participants (PwMS and HC) will follow the same schedule | Device | Healthy Control Persons (HC), Patients with Multiple Sclerosis (PwMS) |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ludwig Kappos study director
Research Center for Clinical Neuroimmunology and Neuroscience Basel
Jannis Müller principal investigator
RC2NB and Department of Neurology, University Hospital of Basel, Switzerland
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Research Center for Clinical Neuroimmunology and Neuroscience Basel at 6 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of the digital features with the respective measurements of the clinical reference tests (time frame: Baseline to last visit (year two)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.