Multiple SclerosisNCT02952911
Monitoring of Multiple Sclerosis (MS) Participants With the Use of Digital Technology (Smartphones and Smartwatches) - A Feasibility Study
A study testing Smartphone and Smartwatch in people with Multiple Sclerosis, run by Hoffmann-La Roche at 2 sites in 2 countries.
Trial summary
This prospective pilot study will assess the feasibility of remote participant monitoring using digital technology in participants with MS and healthy controls. At the enrollment visit, the participants as well as the healthy controls will be provided with a remote patient monitoring solution which includes… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Smartphone and Smartwatch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 28 Nov 2016to 4 May 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- For MS Participants:
- Definite diagnosis of MS, confirmed as per the revised McDonald 2010 criteria
- Expanded Disability Status Scale (EDSS) of 0.0 to 5.5, inclusive
- For All Participants:
- Weight: 45 to 110 kilograms (kg)
Who cannot join
- For MS Participants:
- Severely ill and unstable participants as per investigator's discretion
- Change in dosing regimen or switch of Disease Modifying Therapy (DMT) in the last 12 weeks prior to enrollment
- For All Participants:
- Pregnant or lactating, or intending to become pregnant during the study
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
UCSF- Multiple Sclerosis Centre; Department of Neurology
San Francisco, California, CA94158
About this study
This prospective pilot study will assess the feasibility of remote participant monitoring using digital technology in participants with MS and healthy controls. At the enrollment visit, the participants as well as the healthy controls will be provided with a remote patient monitoring solution which includes preconfigured smartphone and smartwatch. The configured smartphone and smartwatch pair will contain application software that prompts the user to perform various assessments, referred to as active tests and passive monitoring. Active tests will include Hand Motor Function Test (HMFT), gait test, static balance test, electronic version of the Symbol Digit Modalities Test (eSDMT), Mood Scale Question (MSQ), MS Impact Scale (29-item scale) (MSIS-29) questionnaire, MS Symptom Tracking (MSST). Passive monitoring will be done to collect metrics on gait and mobility throughout the daily life of participants in a continuous and unobtrusive manner.
- Conditions
- Multiple Sclerosis
- Being tested
- Smartphone and Smartwatch
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone and SmartwatchDevice
Multiple sclerosis participants and healthy controls are required to wear the smartwatch; and to carry smartphone preferably in a median position in a belt bag, or alternatively in their pocket as they go about their daily routine.
| Study group | Role | What they receive |
|---|---|---|
| A: MS Participants | Experimental | MS participants will perform various active tests (daily, weekly or bi-weekly) and passive monitoring (daily) using smartphone and smartwatch over 24 weeks. Receives: Device: Smartphone and Smartwatch |
| B: Healthy Controls | Other | Healthy participants will perform various active tests (daily, weekly or bi-weekly) and passive monitoring (daily) using smartphone and smartwatch over 24 weeks. Receives: Device: Smartphone and Smartwatch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance Level: Number of Active and Passive Tests Conducted by MS Participants and Healthy Controls in 12 Weeks
Measured: Week 12
Compliance Level: Number of Active and Passive Tests Conducted by MS Participants and Healthy Controls in 24 Weeks
Measured: Week 24
Satisfaction Questionnaire Score at Week 12: Assessment of MS Participants' and Healthy Volunteers' Experience Regarding Smartphone and Smartwatch Use and its Impact on Their Daily Activities
Measured: Week 12
Satisfaction Questionnaire Score at Week 24: Assessment of MS Participants' and Healthy Volunteers' Experience Regarding Smartphone and Smartwatch Use and its Impact on Their Daily Activities
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2016 (estimated)
- Study start28 Nov 2016
- Primary completion4 May 2018
- Study completion4 May 2018
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.
- More trials run by Hoffmann-La RocheThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02952911
- Sponsor's protocol ID
- MA30162
- Status last verified
- Feb 2019
- First submitted
- 1 Nov 2016
- Last updated
- 22 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Graves JS, Elantkowski M, Zhang YP, Dondelinger F, Lipsmeier F, Bernasconi C, Montalban X, Midaglia L, Lindemann M. Assessment of Upper Extremity Function in Multiple Sclerosis: Feasibility of a Digital Pinching Test. JMIR Form Res. 2023 Oct 2;7:e46521. doi: 10.2196/46521.
PubMed 37782540Montalban X, Graves J, Midaglia L, Mulero P, Julian L, Baker M, Schadrack J, Gossens C, Ganzetti M, Scotland A, Lipsmeier F, van Beek J, Bernasconi C, Belachew S, Lindemann M, Hauser SL. A smartphone sensor-based digital outcome assessment of multiple sclerosis. Mult Scler. 2022 Apr;28(4):654-664. doi: 10.1177/13524585211028561. Epub 2021 Jul 14.
PubMed 34259588Midaglia L, Mulero P, Montalban X, Graves J, Hauser SL, Julian L, Baker M, Schadrack J, Gossens C, Scotland A, Lipsmeier F, van Beek J, Bernasconi C, Belachew S, Lindemann M. Adherence and Satisfaction of Smartphone- and Smartwatch-Based Remote Active Testing and Passive Monitoring in People With Multiple Sclerosis: Nonrandomized Interventional Feasibility Study. J Med Internet Res. 2019 Aug 30;21(8):e14863. doi: 10.2196/14863.
PubMed 31471961
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of Multiple Sclerosis (MS) Participants With the Use of Digital Technology (Smartphones and Smartwatches) - A Feasibility Study
- ClinicalTrials.gov ID
- NCT02952911
- Acronym / sponsor ID
- MA30162
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 28 Nov 2016 (actual)
- Primary completion
- 4 May 2018 (actual)
- Study completion
- 4 May 2018 (actual)
- First posted
- 2 Nov 2016 (estimated)
- 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 prospective pilot study will assess the feasibility of remote participant monitoring using digital technology in participants with MS and healthy controls. At the enrollment visit, the participants as well as the healthy controls will be provided with a remote patient monitoring solution which includes preconfigured smartphone and smartwatch. The configured smartphone and smartwatch pair will contain application software that prompts the user to perform various assessments, referred to as active tests and passive monitoring. Active tests will include Hand Motor Function Test (HMFT), gait test, static balance test, electronic version of the Symbol Digit Modalities Test (eSDMT), Mood Scale Question (MSQ), MS Impact Scale (29-item scale) (MSIS-29) questionnaire, MS Symptom Tracking (MSST). Passive monitoring will be done to collect metrics on gait and mobility throughout the daily life of participants in a continuous and unobtrusive manner.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: MS Participants | Experimental | Device: Smartphone and SmartwatchMS participants will perform various active tests (daily, weekly or bi-weekly) and passive monitoring (daily) using smartphone and smartwatch over 24 weeks. |
| B: Healthy Controls | Other | Device: Smartphone and SmartwatchHealthy participants will perform various active tests (daily, weekly or bi-weekly) and passive monitoring (daily) using smartphone and smartwatch over 24 weeks. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Definite diagnosis of MS, confirmed as per the revised McDonald 2010 criteria
- Expanded Disability Status Scale (EDSS) of 0.0 to 5.5, inclusive
- Weight: 45 to 110 kilograms (kg)
Key exclusion criteria (5 listed)
- Severely ill and unstable participants as per investigator's discretion
- Change in dosing regimen or switch of Disease Modifying Therapy (DMT) in the last 12 weeks prior to enrollment
- Pregnant or lactating, or intending to become pregnant during the study
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 |
|---|---|---|
| Smartphone and SmartwatchMultiple sclerosis participants and healthy controls are required to wear the smartwatch; and to carry smartphone preferably in a median position in a belt bag, or alternatively in their pocket as they go about their daily routine. | Device | A: MS Participants, B: Healthy Controls |
Primary outcome
Compliance Level: Number of Active and Passive Tests Conducted by MS Participants and Healthy Controls in 12 Weeks
Time frame: Week 12
Compliance Level: Number of Active and Passive Tests Conducted by MS Participants and Healthy Controls in 24 Weeks
Time frame: Week 24
Satisfaction Questionnaire Score at Week 12: Assessment of MS Participants' and Healthy Volunteers' Experience Regarding Smartphone and Smartwatch Use and its Impact on Their Daily Activities
Time frame: Week 12
Satisfaction Questionnaire Score at Week 24: Assessment of MS Participants' and Healthy Volunteers' Experience Regarding Smartphone and Smartwatch Use and its Impact on Their Daily Activities
Time frame: Week 24
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 22 Feb 2019.
- Derived from this study: PubMed 37782540Graves JS, Elantkowski M, Zhang YP, Dondelinger F, Lipsmeier F, Bernasconi C, Montalban X, Midaglia L, Lindemann M. Assessment of Upper Extremity Function in Multiple Sclerosis: Feasibility of a Digital Pinching Test. JMIR Form Res. 2023 Oct 2;7:e46521. doi: 10.2196/46521.
- Derived from this study: PubMed 34259588Montalban X, Graves J, Midaglia L, Mulero P, Julian L, Baker M, Schadrack J, Gossens C, Ganzetti M, Scotland A, Lipsmeier F, van Beek J, Bernasconi C, Belachew S, Lindemann M, Hauser SL. A smartphone sensor-based digital outcome assessment of multiple sclerosis. Mult Scler. 2022 Apr;28(4):654-664. doi: 10.1177/13524585211028561. Epub 2021 Jul 14.
- Derived from this study: PubMed 31471961Midaglia L, Mulero P, Montalban X, Graves J, Hauser SL, Julian L, Baker M, Schadrack J, Gossens C, Scotland A, Lipsmeier F, van Beek J, Bernasconi C, Belachew S, Lindemann M. Adherence and Satisfaction of Smartphone- and Smartwatch-Based Remote Active Testing and Passive Monitoring in People With Multiple Sclerosis: Nonrandomized Interventional Feasibility Study. J Med Internet Res. 2019 Aug 30;21(8):e14863. doi: 10.2196/14863.
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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.
Clinical Trials study director
Hoffmann-La Roche
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone and Smartwatch in people with Multiple Sclerosis, run by Hoffmann-La Roche at 2 sites in 2 countries.
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 5 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 22 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Spain. 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?
Compliance Level: Number of Active and Passive Tests Conducted by MS Participants and Healthy Controls in 12 Weeks (time frame: Week 12). The study lists 4 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 NCT02952911, 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 22 Feb 2019.