Multiple SclerosisNCT04288011
Validation of the BeCare Multiple Sclerosis Assessment App
An observational study of Multiple Sclerosis, run by BeCare Link LLC at 1 site in United States.
Trial summary
This study involves data collection from use of the BeCare Link LLC mobile device app by subjects with Multiple Sclerosis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2021to 20 Feb 2023
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with mild to moderate Multiple Sclerosis that can use a mobile app and are ambulatory.
Who may be able to join
- A history of Multiple Sclerosis, which will be verified through medical records and will be classified as clinically definite based on revised McDonald criteria
- Between the ages 18-75
- Mild to moderate disability in one or more of the modalities assessed by the BeCare App.
- Ability to provide Informed Consent.
Who cannot join
- Subjects at risk of falling
- Subjects with poor vision that cannot read the screen of a mobile phone
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University School of Medicine
New Haven, Connecticut, 06520
About this study
This study involves data collection from use of the BeCare Link LLC mobile device app by subjects with Multiple Sclerosis.
Read the detailed description
Subjects will be enrolled in the study over a period of 12 months beginning at the time of IRB approval or until a complete data set is collected on 50 subjects. This will be a longitudinal study following individual patients for six months and data collection for all patients will continue for a total of 18 months. Patients will be enrolled during their first visit. Additionally, at the first visit for each patient, an EDSS score will be measured, app training performed, and the first app-obtained measurements entered. The patients will be contacted by the research assistant to complete the app tasks on a weekly basis. Clinical EDSS scores will be measured in the clinic at 3 month and 6 month follow-up appointments Research personnel at the Clinical Site will screen for eligible subjects and obtain informed consent. The data collected from the application will continue to be sent to the sponsor.
The purpose of the BeCare App is to replicate the clinically-derived EDSS score. Because the app can be used independently by the patients at more frequent intervals, use of the app may lead to earlier detection of a decline in function than would be possible by clinic evaluations; the app would measure function utilizing data that closely parallels the clinically obtained EDSS score. In the clinic it may take up to two years before someone is noted to have progressive features. The implication of using the BeCare MS App is earlier intervention with switching to more effective Disease Modifying Treatment. Further, as the BeCare App has a cognitive assessment component not routinely performed during follow-up clinical visits, the need for earlier intervention may result in more effective therapy and, therefore, slowed disease progression.
The EDSS is scored by first assessing Human Functional systems (FS) scores. These systems include Sensory, Bowel\& Bladder, Cerebral, Ambulation and Visual. Function System Scores correspond to the amount of observed disability in that system. Low scores 0 represent no disability in that system, to a maximum score representing high disability.
Clinicians then assess EDSS scores from these Functional System scores (FS) according to their experience with patients. The EDSS is scored according to the following:
0 Normal neurological exam, no disability in any FS 1.0 No disability, minimal signs in one FS 1.5 No disability, minimal signs in more than one FS 2.0 Minimal disability in one FS 2.5 Mild disability in one FS or minimal disability in two FS 3.0 Moderate disability in one FS, or mild disability in three or four FS. No impairment to walking 3.5 Moderate disability in one FS and more than minimal disability in several others. No impairment to walking 4.0 Significant disability but self-sufficient and up and about some 12 hours a day. Able to walk without aid or rest for 500m 4.5 Significant disability but up and about much of the day, able to work a full day, may otherwise have some limitation of full activity or require minimal assistance. Able to walk without aid or rest for 300m 5.0 Disability severe enough to impair full daily activities and ability to work a full day without special provisions. Able to walk without aid or rest for 200m 5.5 Disability severe enough to preclude full daily activities. Able to walk without aid or rest for 100m 6.0 Requires a walking aid - cane, crutch, etc. - to walk about 100m with or without resting 6.5 Requires two walking aids - pair of canes, crutches, etc. - to walk about 20m without resting 7.0 Unable to walk beyond approximately 5m even with aid. Essentially restricted to wheelchair; though wheels self in standard wheelchair and transfers alone. Up and about in wheelchair some 12 hours a day 7.5 Unable to take more than a few steps. Restricted to wheelchair and may need aid in transferring. Can wheel self but cannot carry on in standard wheelchair for a full day and may require a motorised wheelchair 8.0 Essentially restricted to bed or chair or pushed in wheelchair. May be out of bed itself much of the day. Retains many self-care functions. Generally has effective use of arms 8.5 Essentially restricted to bed much of day. Has some effective use of arms retains some self-care functions 9.0 Confined to bed. Can still communicate and eat 9.5 Confined to bed and totally dependent. Unable to communicate effectively or eat/swallow 10.0 Death due to MS
- Conditions
- Multiple Sclerosis
- Keywords
- MS, mobile app, machine learning, EDSS, BeCare
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Clinical EDSS | The Kurtzke EDSS, is a clinical rating scale for multiple sclerosis having scores between 0 to 10 that are assigned by a trained clinician. Smaller impairments are assessed at lower scores and disability is assessed at higher scores. It is important to note, however, that despite being denoted on an ordinal scale, each level on the scale is not indicative of an equal change in disability. | |
| MLA EDSS | The Kurtzke EDSS, is a clinical rating scale or multiple sclerosis having scores between 0 to 10 that are assigned by a technique based upon several different Machine Learning Algorithms that are combined to produce a single score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical EDSS score vs MLA EDSS score comparison
To assess the efficacy of using a mobile application to perform routine assessments of neurological and physical functioning in subjects with MS by comparing clinically assigned EDSS scores with EDSS scores assigned by a single or multiple artificial intelligence techniques at various timed intervals
Measured: day 1 (initial visit)
Clinical EDSS score vs MLA EDSS score comparison
To assess the efficacy of using a mobile application to perform routine assessments of neurological and physical functioning in subjects with MS by comparing clinically assigned EDSS scores with EDSS scores assigned by a single or multiple artificial intelligence techniques at various timed intervals
Measured: 90 days after day 1
Clinical EDSS score vs MLA EDSS score comparison
To assess the efficacy of using a mobile application to perform routine assessments of neurological and physical functioning in subjects with MS by comparing clinically assigned EDSS scores with EDSS scores assigned by a single or multiple artificial intelligence techniques at various timed intervals
Measured: 180 days after day 1
Secondary outcomes (2)
Disease Progression Measured by Change in EDSS score
To improve the understanding of disease progression over a shorter time interval captured by weekly BeCare application's monitoring.
Measured: weekly for 26 weeks
Development of a novel application to measure change in MS
To assist in the development of a novel application that is easy to use and is capable of evaluating MS patients' neurological and physical functioning outside the clinical setting, that allows both patients and clinicians to view their disease progression over time. The data this application will collect could prove to be a valuable source of information and may improve how well MS symptoms and functioning can be evaluated by healthcare providers.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start26 Feb 2021
- Primary completion20 Dec 2022
- Study completion20 Feb 2023
Why it stopped: Study was ended because of COVID19. Patients did not want to come to hospital for continued participation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- BeCare Link LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Yale University
- Responsible party
- Sponsor
- Investigators
- Sharon Stoll, DO,MS, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04288011
- Sponsor's protocol ID
- 2000023992
- Status last verified
- Sep 2026
- First submitted
- 22 Feb 2020
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Polman CH, Reingold SC, Banwell B, Clanet M, Cohen JA, Filippi M, Fujihara K, Havrdova E, Hutchinson M, Kappos L, Lublin FD, Montalban X, O'Connor P, Sandberg-Wollheim M, Thompson AJ, Waubant E, Weinshenker B, Wolinsky JS. Diagnostic criteria for multiple sclerosis: 2010 revisions to the McDonald criteria. Ann Neurol. 2011 Feb;69(2):292-302. doi: 10.1002/ana.22366.
PubMed 21387374Sebastiao E, Sandroff BM, Learmonth YC, Motl RW. Validity of the Timed Up and Go Test as a Measure of Functional Mobility in Persons With Multiple Sclerosis. Arch Phys Med Rehabil. 2016 Jul;97(7):1072-7. doi: 10.1016/j.apmr.2015.12.031. Epub 2016 Mar 2.
PubMed 26944709Berrigan LI, Fisk JD, Walker LA, Wojtowicz M, Rees LM, Freedman MS, Marrie RA. Reliability of regression-based normative data for the oral symbol digit modalities test: an evaluation of demographic influences, construct validity, and impairment classification rates in multiple sclerosis samples. Clin Neuropsychol. 2014;28(2):281-99. doi: 10.1080/13854046.2013.871337. Epub 2014 Jan 20.
PubMed 24438521
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the BeCare Multiple Sclerosis Assessment App
- ClinicalTrials.gov ID
- NCT04288011
- Acronym / sponsor ID
- 2000023992
- Conditions
- Multiple Sclerosis
- Keywords
- MS, mobile app, machine learning, EDSS, BeCare
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study was ended because of COVID19. Patients did not want to come to hospital for continued participation
- Enrolment
- 30 participants (actual)
- Lead sponsor
- BeCare Link LLCIndustry (pharma, biotech, devices)
- Collaborators
- Yale University
- Study start
- 26 Feb 2021 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 20 Feb 2023 (actual)
- First posted
- 27 Feb 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.
This study involves data collection from use of the BeCare Link LLC mobile device app by subjects with Multiple Sclerosis.
Detailed description
Subjects will be enrolled in the study over a period of 12 months beginning at the time of IRB approval or until a complete data set is collected on 50 subjects. This will be a longitudinal study following individual patients for six months and data collection for all patients will continue for a total of 18 months. Patients will be enrolled during their first visit. Additionally, at the first visit for each patient, an EDSS score will be measured, app training performed, and the first app-obtained measurements entered. The patients will be contacted by the research assistant to complete the app tasks on a weekly basis. Clinical EDSS scores will be measured in the clinic at 3 month and 6 month follow-up appointments Research personnel at the Clinical Site will screen for eligible subjects and obtain informed consent. The data collected from the application will continue to be sent to the sponsor.
The purpose of the BeCare App is to replicate the clinically-derived EDSS score. Because the app can be used independently by the patients at more frequent intervals, use of the app may lead to earlier detection of a decline in function than would be possible by clinic evaluations; the app would measure function utilizing data that closely parallels the clinically obtained EDSS score. In the clinic it may take up to two years before someone is noted to have progressive features. The implication of using the BeCare MS App is earlier intervention with switching to more effective Disease Modifying Treatment. Further, as the BeCare App has a cognitive assessment component not routinely performed during follow-up clinical visits, the need for earlier intervention may result in more effective therapy and, therefore, slowed disease progression.
The EDSS is scored by first assessing Human Functional systems (FS) scores. These systems include Sensory, Bowel\& Bladder, Cerebral, Ambulation and Visual. Function System Scores correspond to the amount of observed disability in that system. Low scores 0 represent no disability in that system, to a maximum score representing high disability.
Clinicians then assess EDSS scores from these Functional System scores (FS) according to their experience with patients. The EDSS is scored according to the following:
0 Normal neurological exam, no disability in any FS 1.0 No disability, minimal signs in one FS 1.5 No disability, minimal signs in more than one FS 2.0 Minimal disability in one FS 2.5 Mild disability in one FS or minimal disability in two FS 3.0 Moderate disability in one FS, or mild disability in three or four FS. No impairment to walking 3.5 Moderate disability in one FS and more than minimal disability in several others. No impairment to walking 4.0 Significant disability but self-sufficient and up and about some 12 hours a day. Able to walk without aid or rest for 500m 4.5 Significant disability but up and about much of the day, able to work a full day, may otherwise have some limitation of full activity or require minimal assistance. Able to walk without aid or rest for 300m 5.0 Disability severe enough to impair full daily activities and ability to work a full day without special provisions. Able to walk without aid or rest for 200m 5.5 Disability severe enough to preclude full daily activities. Able to walk without aid or rest for 100m 6.0 Requires a walking aid - cane, crutch, etc. - to walk about 100m with or without resting 6.5 Requires two walking aids - pair of canes, crutches, etc. - to walk about 20m without resting 7.0 Unable to walk beyond approximately 5m even with aid. Essentially restricted to wheelchair; though wheels self in standard wheelchair and transfers alone. Up and about in wheelchair some 12 hours a day 7.5 Unable to take more than a few steps. Restricted to wheelchair and may need aid in transferring. Can wheel self but cannot carry on in standard wheelchair for a full day and may require a motorised wheelchair 8.0 Essentially restricted to bed or chair or pushed in wheelchair. May be out of bed itself much of the day. Retains many self-care functions. Generally has effective use of arms 8.5 Essentially restricted to bed much of day. Has some effective use of arms retains some self-care functions 9.0 Confined to bed. Can still communicate and eat 9.5 Confined to bed and totally dependent. Unable to communicate effectively or eat/swallow 10.0 Death due to MS
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical EDSS | – | –The Kurtzke EDSS, is a clinical rating scale for multiple sclerosis having scores between 0 to 10 that are assigned by a trained clinician. Smaller impairments are assessed at lower scores and disability is assessed at higher scores. It is important to note, however, that despite being denoted on an ordinal scale, each level on the scale is not indicative of an equal change in disability. |
| MLA EDSS | – | –The Kurtzke EDSS, is a clinical rating scale or multiple sclerosis having scores between 0 to 10 that are assigned by a technique based upon several different Machine Learning Algorithms that are combined to produce a single score |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with mild to moderate Multiple Sclerosis that can use a mobile app and are ambulatory.
Key inclusion criteria (4 listed)
- A history of Multiple Sclerosis, which will be verified through medical records and will be classified as clinically definite based on revised McDonald criteria
- Between the ages 18-75
- Mild to moderate disability in one or more of the modalities assessed by the BeCare App.
- Ability to provide Informed Consent.
Key exclusion criteria (2 listed)
- Subjects at risk of falling
- Subjects with poor vision that cannot read the screen of a mobile phone
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
Clinical EDSS score vs MLA EDSS score comparison
Time frame: day 1 (initial visit)
To assess the efficacy of using a mobile application to perform routine assessments of neurological and physical functioning in subjects with MS by comparing clinically assigned EDSS scores with EDSS scores assigned by a single or multiple artificial intelligence techniques at various timed intervals
Clinical EDSS score vs MLA EDSS score comparison
Time frame: 90 days after day 1
To assess the efficacy of using a mobile application to perform routine assessments of neurological and physical functioning in subjects with MS by comparing clinically assigned EDSS scores with EDSS scores assigned by a single or multiple artificial intelligence techniques at various timed intervals
Clinical EDSS score vs MLA EDSS score comparison
Time frame: 180 days after day 1
To assess the efficacy of using a mobile application to perform routine assessments of neurological and physical functioning in subjects with MS by comparing clinically assigned EDSS scores with EDSS scores assigned by a single or multiple artificial intelligence techniques at various timed intervals
2 secondary outcomes
Disease Progression Measured by Change in EDSS score
Time frame: weekly for 26 weeks
Development of a novel application to measure change in MS
Time frame: 18 months
Results and safety
The study was stopped early (reason given: Study was ended because of COVID19. Patients did not want to come to hospital for continued participation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Background: PubMed 21387374Polman CH, Reingold SC, Banwell B, Clanet M, Cohen JA, Filippi M, Fujihara K, Havrdova E, Hutchinson M, Kappos L, Lublin FD, Montalban X, O'Connor P, Sandberg-Wollheim M, Thompson AJ, Waubant E, Weinshenker B, Wolinsky JS. Diagnostic criteria for multiple sclerosis: 2010 revisions to the McDonald criteria. Ann Neurol. 2011 Feb;69(2):292-302. doi: 10.1002/ana.22366.
- Background: PubMed 26944709Sebastiao E, Sandroff BM, Learmonth YC, Motl RW. Validity of the Timed Up and Go Test as a Measure of Functional Mobility in Persons With Multiple Sclerosis. Arch Phys Med Rehabil. 2016 Jul;97(7):1072-7. doi: 10.1016/j.apmr.2015.12.031. Epub 2016 Mar 2.
- Background: PubMed 24438521Berrigan LI, Fisk JD, Walker LA, Wojtowicz M, Rees LM, Freedman MS, Marrie RA. Reliability of regression-based normative data for the oral symbol digit modalities test: an evaluation of demographic influences, construct validity, and impairment classification rates in multiple sclerosis samples. Clin Neuropsychol. 2014;28(2):281-99. doi: 10.1080/13854046.2013.871337. Epub 2014 Jan 20.
- Individual participant dataSharing planned: No
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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.
Sharon Stoll, DO,MS principal investigator
Yale University
1 site 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 BeCare Link LLC at 1 site in United States.
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 4 inclusion and 2 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: stopped early, as of the sponsor's last update on 30 Sep 2026. 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 United States. 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 was stopped early (reason given: Study was ended because of COVID19. Patients did not want to come to hospital for continued participation). 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?
Clinical EDSS score vs MLA EDSS score comparison (time frame: day 1 (initial visit)). 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 NCT04288011, which also lists 3 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 30 Sep 2026.