Multiple SclerosisMSCopilotNCT03148938
Digitalization of Neurofunctional Tests Via a Mobile Application DAMS for Multiple Sclerosis Patients
A study testing Digital Assessment on mobile in people with Multiple Sclerosis, run by Ad scientiam at 10 sites in France.
Trial summary
Multiple Sclerosis (MS) is a chronic immune-mediated inflammatory disease with a broad diversity of symptoms and fluctuating progression patterns. Clinical assessments are challenging and are continually reviewed and enhanced. Optimal multiple sclerosis care depends on early detection of disease progression. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Digital Assessment on mobile
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 10 sitesFrance
- Study dates
- 2 Oct 2017to 29 Aug 2018
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- MS patients:
- subjects: 18 Years to 60 Years
- with a confirmed and documented MS diagnosis, per the 2010 Revised McDonald criteria
- with or without MS maintenance and/or symptomatic treatment, if MS maintenance and/or symptomatic treatment: stable for the past 6 months before enrolment (Centrally acting antalgics, antidepressant or neuroleptic treatment are authorized but shall not be modified in the past 2 months before enrolment)
- with an EDSS [0;7] in the past 6 months before enrolment
- with an EDSS [0;7] in the past 6 months before enrolment
Show all 35Show fewer
- with no evidence of EDSS score change since the last measure available
- with no evidence of relapse in the past 6 months before enrolment
- enrolled in or benefiting of a Social Security program
- who have read the information sheet and signed the informed consent form
- Healthy volunteers:
- subjects: 18 Years to 60 Years
- with no evidence of walk limitation (as per clinician's judgment) nor walking aid
- no personal and familial history of inflammatory disease (e.g. rheumatoid arthritis) or multiple sclerosis
- matched to the sociodemographic characteristics of MS patients sample (age, sex, height, weight, education)
- enrolled in or benefiting of a Social Security program
- who have read the information sheet and signed the informed consent form
- Non-Inclusion Criteria:
- MS patients and Healthy volunteers:
- Participants wearing pacemakers, implantable defibrillators, or hearing aids
- Inability to use their right hand for the Coordination test (MCT)
- Evidence of neurologic or psychiatric disorder other than MS, including but not limited to major head trauma, seizures or systemic medical diseases that are likely to affect cognitive functioning
- Evolutive rheumatology disease
- Any vision (ex. short-sightedness (-6; +6); congenital dyschromatopsia and glaucoma) or hearing conditions that could influence the performing of the tests
- Omission of the usual visual and/or walking aids if it's usually needed
- Acute asthenia (score>7 on a visual analogic scale)
- Systemic corticosteroid treatment in the past 30 days before enrolment
- Intramuscular botulinic toxin injection in the past 4 months before enrolment
- Change in centrally acting antalgic, antidepressant or neuroleptic treatment in the past 2 months before enrolment
- Rehabilitation in the past 6 months before enrolment
- Pregnant and nursing women - Person under guardianship or curatorship
- Bedridden patients or patients with a daily activity of less than 2 hours per day
- Inability to use a mobile application
- Current drugs or/and alcohol abuse that could influence performance on the tests (clinician's judgment)
- Participation to another study Healthy volunteers who will not match the sociodemographic characteristics of MS patients will not be included in the study.
Who cannot join
- Patient experiencing a relapse once enrolled in the study
- Patient with a maintenance and symptomatic MS treatment modification
- Use of centrally acting antalgics, antidepressant or neuroleptic once enrolled in the study
- Substance or/and alcohol abuse that could influence performance on the tests between inclusion and follow-up visits (clinician's judgement)
- Omission or change in the usual visual and/or walking aids
- Acute asthenia (score>7 on a visual analogic scale) at the follow-up visit.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
Hôpital le Bocage
Dijon
Hôpital Saint-Phllibert
Lille
Hôpital La Timone Adulte
Marseille
Hôpital Gui de Chauliac
Montpellier
Hôpital Pasteur
Nice
Hôpital Pitié Salpêtrière
Paris
Hôpital Maison Blanche
Reims
Hôpital Saint Hélier
Rennes
Hôpital Charles Nicolle
Rouen
Hôpital Hautepierre
Strasbourg
About this study
Official title: " Digitalization of Neurofunctional Tests Via a Mobile Application, Digital Assessment Multiple Sclerosis (DAMS), for Multiple Sclerosis Patients"
Multiple Sclerosis (MS) is a chronic immune-mediated inflammatory disease with a broad diversity of symptoms and fluctuating progression patterns. Clinical assessments are challenging and are continually reviewed and enhanced. Optimal multiple sclerosis care depends on early detection of disease progression. The Digital self-Assessment for Multiple sclerosis (DAM) mobile program was developed by Ad Scientiam in order to create a robust and clinically validated remote monitoring platform for MS patients and clinicians. The correlation between DAM version 0 (the first iteration of DAMS) and Multiple Sclerosis Functional Composite (MSFC) has been clinically evaluated in a preliminary study in 30 subjects. DAM version 0 and MFSC global scores were correlated. However, the cognition test had a poor reproducibility and clinicians expressed the wish to measure a walking range rather than a walking speed. Even though vision is the main sense impacting all other tests, particularly when interacting with a mobile, visual tests are rarely performed in real life. A new version of DAM version 0, DAMS, was therefore developed with the addition of the Sloan Low Contrast Letter Acuity Test (SLCLAT), the replacement of the walking speed test with a walking distance test and the Paced Auditory Serial Addition Test (PASAT) by a new version of the cognitive test which resembles the Symbol Digit Modalities Test (SDMT).
The hypothesis is that systematic and prospective multi-dimensional data collection of MS disabilities through the DAMS mobile application will refine the quality and accuracy of both clinicians and patients' knowledge of the disease progression and will ultimately improve the current care of patients.
Read more
To test this assumption, the statistician will analyze:
- The global diagnostic performance of DAMS with (DAMS 4 tests) and without (DAMS 3 tests) the low contrast vision test versus standard MS scales
- The test-retest reliability of DAMS' scores at a 15 day interval
- Conditions
- Multiple Sclerosis
- Being tested
- Digital Assessment on mobile
- Keywords
- DAM, multiple sclerosis, MSFC, application, mobile
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Assessment on mobileOther
The digital assessment is composed on 4 tests:
- walking test
- coordination test
- attention test
- vision test
| Study group | Role | What they receive |
|---|---|---|
| Patients with Multiple Sclerosis | Experimental | Patients will perform one or two visits at 15 days interval. Patients will be randomly assigned to either traditional/digital group (Group A) or digital/traditional group (Group B), followed by a crossover to the other group at day 15 for patients who will do two visits. Receives: Other: Digital Assessment on mobile |
| Healthy volunteer | Active comparator | Healthy volunteers will only perform one visit. Healthy volunteers will be randomly assigned to either traditional/digital group (Group A) or digital/traditional group (Group B). Receives: Other: Digital Assessment on mobile |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of DAMS 3 test measured with digital assessment versus MSFC measured with traditional tests.
Determine the diagnostic performance of DAMS 3 tests (not included the vision test results) for the detection of MS patients in a population of healthy volunteers and MS patients (with Expanded Disability Status Scale (EDDSS) score [0;7]) compared to the traditional tests (MSFC)
Measured: Day 0
Secondary outcomes (10)
Diagnostic performance of DAMS 4 tests measured with digital assessment versus MSFC (with vision test) measured with traditional tests
Determine the diagnostic performance of DAMS 4 tests (included the vision test results) for the detection of MS patients in a population of healthy volunteers and MS patients (with Expanded Disability Status Scale (EDSS) score [0;7]) compared to the conventional MSFC + Sloan low contrast letter acuity test
Measured: Day 0
Diagnostic performance of DAMS 3 tests measured with digital assessment versus MSFC revised measured with traditional tests
Determine the diagnostic performance of DAMS 3 tests for the detection of MS patients in a population of healthy volunteers and MS patients (with EDSS score [0;7]) compared to a revised form of MSFC in which PASAT has been replaced by SDMT
Measured: Day 0
Diagnostic performance of DAMS 4 test measured with digital assessment versus MSFC revised with vision test measured with traditional tests
Determine the diagnostic performance of DAMS 4 tests for the detection of MS patients in a population of healthy volunteers and MS patients (with EDSS score [0;7]) compared to a revised form of MSFC in which PASAT has been replaced by SDMT and SLCLAT added.
Measured: Day 0
Correlation between DAMS 3 tests measured with digital assessment and MSFC measured with traditional tests
To assess correlation between DAMS 3 tests and MSFC in MS patients and healthy volunteers
Measured: Day 0
Correlation between DAMS 3 tests measured with digital assessment and MSFC revised measured with traditional tests
To assess correlation between DAMS 3 tests and MSFC in which PASAT has been replaced by SDMT in MS patients and healthy volunteers
Measured: Day 0
Correlation between DAMS 4 tests measured with digital assessment and MSFC with vision test measured with traditional tests
To assess correlation between DAMS 4 tests and MSFC with vision test result in MS patients and healthy volunteers
Measured: Day 0
Correlation between DAMS 3 tests measured with digital assessment and MSFC revised with vision test measured with traditional tests
- assess correlation between DAMS 3 tests and MSFC in which PASAT has been replaced by SDMT with vision test result in MS patients and healthy volunteers
Measured: Day 0
Compare scores of digital assessment versus scores of traditional tests
To compare the scores obtained with each DAMS' evaluation test [mobile walking test, coordination test, attention test, vision test ] to those obtained with traditional tests (T25FW, 9-HPT, PASAT, SDMT, SLCLAT) in MS patients and healthy volunteers
Measured: Day 0
Compare scores of digital assessment at day 0 versus 15 days later
To assess the test-retest reliability of DAMS 3 and 4 tests during the study in MS patients with EDSS score [0;7]
Measured: Day 15
Safety of Mobile assessment with the collect of all the adverse events
Measured: Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start2 Oct 2017
- Primary completion30 Jul 2018
- Study completion29 Aug 2018
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Patients will perform one or two visits at 15 days interval. Healthy volunteers will only perform one visit. Patients and healthy volunteers will be randomly assigned to either traditional/digital group (Group A) or digital/traditional group (Group B), followed by a crossover to the other group at day 15 for patients who will do two visits.
- Masking
- None (open label)
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ad scientiam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisabeth MAILLART, MD, Principal investigator, Pitié-Salpêtrière Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03148938
- Sponsor's protocol ID
- P005
- Acronym
- MSCopilot
- Status last verified
- Jul 2018
- First submitted
- 5 May 2017
- Last updated
- 14 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- " Digitalization of Neurofunctional Tests Via a Mobile Application, Digital Assessment Multiple Sclerosis (DAMS), for Multiple Sclerosis Patients"
- ClinicalTrials.gov ID
- NCT03148938
- Acronym / sponsor ID
- MSCopilot / P005
- Conditions
- Multiple Sclerosis
- Keywords
- DAM, multiple sclerosis, MSFC, application, mobile
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Ad scientiamUniversity, hospital or other
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 29 Aug 2018 (actual)
- First posted
- 11 May 2017 (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 immune-mediated inflammatory disease with a broad diversity of symptoms and fluctuating progression patterns. Clinical assessments are challenging and are continually reviewed and enhanced. Optimal multiple sclerosis care depends on early detection of disease progression. The Digital self-Assessment for Multiple sclerosis (DAM) mobile program was developed by Ad Scientiam in order to create a robust and clinically validated remote monitoring platform for MS patients and clinicians. The correlation between DAM version 0 (the first iteration of DAMS) and Multiple Sclerosis Functional Composite (MSFC) has been clinically evaluated in a preliminary study in 30 subjects. DAM version 0 and MFSC global scores were correlated. However, the cognition test had a poor reproducibility and clinicians expressed the wish to measure a walking range rather than a walking speed. Even though vision is the main sense impacting all other tests, particularly when interacting with a mobile, visual tests are rarely performed in real life. A new version of DAM version 0, DAMS, was therefore developed with the addition of the Sloan Low Contrast Letter Acuity Test (SLCLAT), the replacement of the walking speed test with a walking distance test and the Paced Auditory Serial Addition Test (PASAT) by a new version of the cognitive test which resembles the Symbol Digit Modalities Test (SDMT).
The hypothesis is that systematic and prospective multi-dimensional data collection of MS disabilities through the DAMS mobile application will refine the quality and accuracy of both clinicians and patients' knowledge of the disease progression and will ultimately improve the current care of patients.
To test this assumption, the statistician will analyze:
- The global diagnostic performance of DAMS with (DAMS 4 tests) and without (DAMS 3 tests) the low contrast vision test versus standard MS scales
- The test-retest reliability of DAMS' scores at a 15 day interval
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will perform one or two visits at 15 days interval. Healthy volunteers will only perform one visit. Patients and healthy volunteers will be randomly assigned to either traditional/digital group (Group A) or digital/traditional group (Group B), followed by a crossover to the other group at day 15 for patients who will do two visits.
| Arm | Type | Receives |
|---|---|---|
| Patients with Multiple Sclerosis | Experimental | Other: Digital Assessment on mobilePatients will perform one or two visits at 15 days interval. Patients will be randomly assigned to either traditional/digital group (Group A) or digital/traditional group (Group B), followed by a crossover to the other group at day 15 for patients who will do two visits. |
| Healthy volunteer | Active comparator | Other: Digital Assessment on mobileHealthy volunteers will only perform one visit. Healthy volunteers will be randomly assigned to either traditional/digital group (Group A) or digital/traditional group (Group B). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (35 listed)
- subjects: 18 Years to 60 Years
- with a confirmed and documented MS diagnosis, per the 2010 Revised McDonald criteria
- with or without MS maintenance and/or symptomatic treatment, if MS maintenance and/or symptomatic treatment: stable for the past 6 months before enrolment (Centrally acting antalgics, antidepressant or neuroleptic treatment are authorized but shall not be modified in the past 2 months before enrolment)
- with an EDSS [0;7] in the past 6 months before enrolment
- with an EDSS [0;7] in the past 6 months before enrolment
Key exclusion criteria (6 listed)
- Patient experiencing a relapse once enrolled in the study
- Patient with a maintenance and symptomatic MS treatment modification
- Use of centrally acting antalgics, antidepressant or neuroleptic once enrolled in the study
- Substance or/and alcohol abuse that could influence performance on the tests between inclusion and follow-up visits (clinician's judgement)
- Omission or change in the usual visual and/or walking aids
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 |
|---|---|---|
| Digital Assessment on mobileThe digital assessment is composed on 4 tests: * walking test * coordination test * attention test * vision test | Other | Healthy volunteer, Patients with Multiple Sclerosis |
Primary outcome
Diagnostic performance of DAMS 3 test measured with digital assessment versus MSFC measured with traditional tests.
Time frame: Day 0
Determine the diagnostic performance of DAMS 3 tests (not included the vision test results) for the detection of MS patients in a population of healthy volunteers and MS patients (with Expanded Disability Status Scale (EDDSS) score [0;7]) compared to the traditional tests (MSFC)
10 secondary outcomes
Diagnostic performance of DAMS 4 tests measured with digital assessment versus MSFC (with vision test) measured with traditional tests
Time frame: Day 0
Diagnostic performance of DAMS 3 tests measured with digital assessment versus MSFC revised measured with traditional tests
Time frame: Day 0
Diagnostic performance of DAMS 4 test measured with digital assessment versus MSFC revised with vision test measured with traditional tests
Time frame: Day 0
Correlation between DAMS 3 tests measured with digital assessment and MSFC measured with traditional tests
Time frame: Day 0
Correlation between DAMS 3 tests measured with digital assessment and MSFC revised measured with traditional tests
Time frame: Day 0
Correlation between DAMS 4 tests measured with digital assessment and MSFC with vision test measured with traditional tests
Time frame: Day 0
Correlation between DAMS 3 tests measured with digital assessment and MSFC revised with vision test measured with traditional tests
Time frame: Day 0
Compare scores of digital assessment versus scores of traditional tests
Time frame: Day 0
Compare scores of digital assessment at day 0 versus 15 days later
Time frame: Day 15
Safety of Mobile assessment with the collect of all the adverse events
Time frame: Day 15
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 14 Sep 2018.
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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.
Elisabeth MAILLART, MD principal investigator
Pitié-Salpêtrière Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Assessment on mobile in people with Multiple Sclerosis, run by Ad scientiam 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 35 inclusion and 6 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 14 Sep 2018. 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?
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?
Diagnostic performance of DAMS 3 test measured with digital assessment versus MSFC measured with traditional tests. (time frame: Day 0). 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 14 Sep 2018.