Multiple SclerosisMSSTNCT04595799
Use of a Smartphone Application to Predict the Prognosis in Patients With Newly Diagnosed Multiple Sclerosis.
An observational study of Multiple Sclerosis, run by Centre Hospitalier Universitaire de Nice at 10 sites in France.
Trial summary
Multiple sclerosis (MS) is a chronic demyelinating disease of the central nervous system for which the investigators now have many treatment alternatives. These treatments have a preventive goal and the data in the literature suggest the interest in rapidly achieving optimal control of the disease in order to decrease… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 240 participants
- Where
- 10 sitesFrance
- Study dates
- 9 Nov 2020to 9 Nov 2025
- Phase
- Observational
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with newly diagnosed multiple sclerosis starting first-line background therapy
Who may be able to join
- Patient between 18 and 60 years of age
- Presenting a diagnosis of relapsing-remitting MS defined according to McDonald 2017 criteria confirmed within 6 months prior to inclusion
- Starting first-line treatment (interferon beta, glatiramer acetate, teriflunomide, dimethyl fumarate)
- Having an encephalic and cervical MRI in OFSEP format, within 6 months prior to inclusion
- No relapse within 30 days prior to inclusion
Who cannot join
- presence of a motor, visual or cognitive deficit not related to MS
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
Lille University Hospital
Lille, 59037
LYON Civil Hospital
Lyon, 69000
Montpellier university hospital
Montpellier, 34295
Nice University Hospital
Nice, 06000
Nimes University Hospital
Nîmes, 30900
Paris University Hospital - la pitié salpétriere
Paris, 75013
Rennes University Hospital
Rennes, 35033
Rouen University hospital
Rouen, 76031
Strasbourg University Hospital
Strasbourg, 67000
Toulouse university hospital
Toulouse, 31059
About this study
Official title: MS Screen Test: Using a Smartphone Application to Predict the Prognosis in Patients With Newly Diagnosed Multiple Sclerosis
Multiple sclerosis (MS) is a chronic demyelinating disease of the central nervous system for which the investigators now have many treatment alternatives. These treatments have a preventive goal and the data in the literature suggest the interest in rapidly achieving optimal control of the disease in order to decrease the risk of long-term disability progression.
One of the current unmet needs is to have markers that can be used at the individual level to predict the long-term prognosis in order to propose optimal and personalized therapeutic management.
Read more
Classically used clinical markers do not meet this need. It is recognized that there is a so-called silent course of MS (not measurable by clinical parameters), which may, after several months or years, be expressed as a physical or cognitive disability.
MRI is the reference examination for monitoring the sub-clinical activity of the disease but it does not allow the neurodegenerative side of the disease to be assessed. Other blood or imaging markers are being studied but are not yet usable in daily practice.
The project aims to evaluate the interest in using digital biomarkers, based on a rapid assessment of patients using a locally developed mobile application (MS Screen Test - MSST) to predict the evolutionary prognosis of the disease.
- Conditions
- Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
speed test in MMST results
the average speed (in taps per second or Hz) for the dominant and non-dominant hand
Measured: 12 months
agility test in MMST results
time required (in seconds) to bring the ball to the target as well as the actual time the ball will be held inside the target (expressed as a percentage of the total recording time)
Measured: 12 months
synchronization test in MMST results
the average time interval expressed in milliseconds separating the left and right index strokes.
Measured: 12 months
visual test in MMST results
number of letters seen
Measured: 12 months
Cognitive test in MMST results
the average response latency (the time in milliseconds between the display and the click on a good answer) expressed in milliseconds, the number of wrong answers as well as the number of missed letters.
the average response latency is the combination of multiple measurements (time of response, number of wrong answers and number of missed letters.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start9 Nov 2020
- Primary completion9 Nov 2025 (estimated)
- Study completion9 Nov 2025 (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.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04595799
- Sponsor's protocol ID
- 20-AOI-01
- Acronym
- MSST
- Status last verified
- May 2024
- First submitted
- 7 Oct 2020
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MS Screen Test: Using a Smartphone Application to Predict the Prognosis in Patients With Newly Diagnosed Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04595799
- Acronym / sponsor ID
- MSST / 20-AOI-01
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 9 Nov 2025 (estimated)
- Study completion
- 9 Nov 2025 (estimated)
- First posted
- 22 Oct 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.
Multiple sclerosis (MS) is a chronic demyelinating disease of the central nervous system for which the investigators now have many treatment alternatives. These treatments have a preventive goal and the data in the literature suggest the interest in rapidly achieving optimal control of the disease in order to decrease the risk of long-term disability progression.
One of the current unmet needs is to have markers that can be used at the individual level to predict the long-term prognosis in order to propose optimal and personalized therapeutic management.
Classically used clinical markers do not meet this need. It is recognized that there is a so-called silent course of MS (not measurable by clinical parameters), which may, after several months or years, be expressed as a physical or cognitive disability.
MRI is the reference examination for monitoring the sub-clinical activity of the disease but it does not allow the neurodegenerative side of the disease to be assessed. Other blood or imaging markers are being studied but are not yet usable in daily practice.
The project aims to evaluate the interest in using digital biomarkers, based on a rapid assessment of patients using a locally developed mobile application (MS Screen Test - MSST) to predict the evolutionary prognosis of the disease.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with newly diagnosed multiple sclerosis starting first-line background therapy
Key inclusion criteria (5 listed)
- Patient between 18 and 60 years of age
- Presenting a diagnosis of relapsing-remitting MS defined according to McDonald 2017 criteria confirmed within 6 months prior to inclusion
- Starting first-line treatment (interferon beta, glatiramer acetate, teriflunomide, dimethyl fumarate)
- Having an encephalic and cervical MRI in OFSEP format, within 6 months prior to inclusion
- No relapse within 30 days prior to inclusion
Key exclusion criteria (1 listed)
- presence of a motor, visual or cognitive deficit not related to MS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
speed test in MMST results
Time frame: 12 months
the average speed (in taps per second or Hz) for the dominant and non-dominant hand
agility test in MMST results
Time frame: 12 months
time required (in seconds) to bring the ball to the target as well as the actual time the ball will be held inside the target (expressed as a percentage of the total recording time)
synchronization test in MMST results
Time frame: 12 months
the average time interval expressed in milliseconds separating the left and right index strokes.
visual test in MMST results
Time frame: 12 months
number of letters seen
Cognitive test in MMST results
Time frame: 12 months
the average response latency (the time in milliseconds between the display and the click on a good answer) expressed in milliseconds, the number of wrong answers as well as the number of missed letters. the average response latency is the combination of multiple measurements (time of response, number of wrong answers and number of missed letters.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
Related trials for Multiple Sclerosis
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Multiple Sclerosis
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.
The record lists no contact. Use the official record to reach the sponsor.
10 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 Centre Hospitalier Universitaire de Nice at 10 sites in France.
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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. 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?
Results are not available in the source record.
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?
speed test in MMST results (time frame: 12 months). The study lists 5 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 17 May 2024.