Multiple SclerosisDreaMSNCT04413032
DreaMS - Digital Biomarkers for Multiple Sclerosis
A study testing DreaMS in people with Multiple Sclerosis, run by Research Center for Clinical Neuroimmunology and Neuroscience Basel at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- DreaMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteSwitzerland
- Study dates
- 5 Oct 2020to 26 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- Age 18-70
- In possession of a smart phone
Who cannot join
- 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
Show all 15Show fewer
- Not in possession of a smart phone
- Healthy Volunteers
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DreaMS - Development of Digital Biomarkers in Multiple Sclerosis - Feasibility Study
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.
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 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.
- Conditions
- Multiple Sclerosis
- Being tested
- DreaMS
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DreaMSDevice
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 group | Role | What they receive |
|---|---|---|
| Patients with MS | Experimental | 30 Patients with MS will use the DreaMS App over a study duration of 6 weeks. Receives: Device: DreaMS |
| Healthy Volunteers | Experimental | 30 Healthy Volunteers will use the DreaMS App over a study duration of 6 weeks. Receives: Device: DreaMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test Reliability of digital biomarkers measured by Intra Class Correlation
Number of digital biomarkers tested with an Intra Class Correlation of at least 0.6 if repeated 10 times
Measured: 6 weeks
Test Reliability of digital biomarkers measured by Coefficient of variation
Number of digital biomarkers tested with a coefficient of Variation of less than 20% if repeated 10 times
Measured: 6 weeks
Determination of user acceptance of each digital biomarker with regards to acceptance based on a questionnaire using a likert scale
Number of digital biomarkers tested with a good acceptance reflected by a mean response of more than 3 on a likert scale.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start5 Oct 2020
- Primary completion26 Feb 2021
- Study completion26 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Center for Clinical Neuroimmunology and Neuroscience Basel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ludwig Kappos, MD, Principal investigator, University Hospital Basel and RC2NB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04413032
- Sponsor's protocol ID
- DreaMS_2020F
- Acronym
- DreaMS
- Status last verified
- Mar 2021
- First submitted
- 12 May 2020
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pless S, Woelfle T, Naegelin Y, Lorscheider J, Wiencierz A, Reyes O, Calabrese P, Kappos L. Assessment of cognitive performance in multiple sclerosis using smartphone-based training games: a feasibility study. J Neurol. 2023 Jul;270(7):3451-3463. doi: 10.1007/s00415-023-11671-9. Epub 2023 Mar 23.
PubMed 36952010Woelfle 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.
PubMed 36042020
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DreaMS - Development of Digital Biomarkers in Multiple Sclerosis - Feasibility Study
- ClinicalTrials.gov ID
- NCT04413032
- Acronym / sponsor ID
- DreaMS / DreaMS_2020F
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Research Center for Clinical Neuroimmunology and Neuroscience BaselUniversity, hospital or other
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 26 Feb 2021 (actual)
- Study completion
- 26 Feb 2021 (actual)
- First posted
- 2 Jun 2020 (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.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Patients with MS | Experimental | Device: DreaMS30 Patients with MS will use the DreaMS App over a study duration of 6 weeks. |
| Healthy Volunteers | Experimental | Device: DreaMS30 Healthy Volunteers will use the DreaMS App over a study duration of 6 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- Age 18-70
Key exclusion criteria (15 listed)
- 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.
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 |
|---|---|---|
| DreaMSThe 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. | Device | Healthy Volunteers, Patients with MS |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
- Derived from this study: PubMed 36952010Pless S, Woelfle T, Naegelin Y, Lorscheider J, Wiencierz A, Reyes O, Calabrese P, Kappos L. Assessment of cognitive performance in multiple sclerosis using smartphone-based training games: a feasibility study. J Neurol. 2023 Jul;270(7):3451-3463. doi: 10.1007/s00415-023-11671-9. Epub 2023 Mar 23.
- Derived from this study: PubMed 36042020Woelfle 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.
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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, MD principal investigator
University Hospital Basel and RC2NB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DreaMS in people with Multiple Sclerosis, run by Research Center for Clinical Neuroimmunology and Neuroscience Basel at 1 site 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 6 inclusion and 15 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: finished, as of the sponsor's last update on 2 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Test Reliability of digital biomarkers measured by Intra Class Correlation (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04413032, which also lists 2 linked publications.
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 2 Mar 2021.