Multiple SclerosisNCT07222618
"Selfie" Videos: A Novel, Patient-centered, Comprehensive Approach to Measuring Function in MS
An observational study of Multiple Sclerosis and Multiple Sclerosis (MS) - Relapsing-remitting, run by University of California, San Francisco at 1 site in United States.
Trial summary
The goal of this observational study is to validate a novel, cost-effective method for real-world assessment using patient-acquired "selfie" videos in people with multiple sclerosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Multiple Sclerosis (MS) - Relapsing-remitting, Multiple Sclerosis (MS) Primary Progressive
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to 1 Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A diverse population of adults with MS
Who may be able to join
- Any patient with MS who is above the age of 18 yrs. Participants who are unable to consent for themselves must have a surrogate decision maker or LAR.
- Age > 18 yrs, EDSS - <6.5, own a video recording device (smartphone, tablet, camera etc).
Who cannot join
- Patient unwilling to participate in the study. Participants unable to consent for themselves who do not have a surrogate decision maker or LAR.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, San Francisco
San Francisco, California, 94158
Kyra Henderson, Study Coordinator, 415-353-8053, kyra.henderson@ucsf.edu
Riley Bove, MD
About this study
The goal of this observational study is to validate a novel, cost-effective method for real-world assessment using patient-acquired "selfie" videos in people with multiple sclerosis. The investigators aim to prove the feasibility and validity of monitoring walking changes remotely through a truly patient-centered, low-burden, low-cost approach. The main question this study aims to answer is: do remotely collected walking and speech videos from a mobile phone match the information investigators can gather from an in person visit?
Participants will collect 5 "selfie" videos at baseline, 3 months, 6 months and 12 months (about 15 minutes every 3 months). They will also come in person at baseline, 6 months, and 12 months for in person data collection (about 1 hour per in person visit).
Read the detailed description
The investigators aim to validate a novel, cost-effective method for real-world assessment using patient-acquired "selfie" videos. The investigator's preliminary data demonstrate feasibility, validity and utility of this technology, which overcomes limitations of existing digital biomarkers and offers a truly patient-centered, low-burden approach to monitoring and treating diverse people with MS (PwMS). The investigators want to understand the barriers and facilitators to adoption of this approach, as well as the real-world validity and impact of the data generated. This will allow investigators to share the most accessible, generalizable and useful protocols and metrics with the MS community.
This approach to digital tool development prioritizes patients and clinicians. Indeed, the investigators leverage a tool used every day by the general population ("selfie" videos) that recapitulates clinicians' primary examination tool: observing how patients talk and walk.
This approach uses the patient's own device (device agnostic: including smartphones sold after 2010, as well as tablets, laptops or desktops with camera capture), without requiring proprietary software or technology, to collect "selfie" videos - which are ubiquitous in modern life - and provides a link to a secure web portal for simple uploading. The task minimizes burden: it is brief (5 <1min videos), can be done in individuals' own homes, requires no direct or indirect costs, and therefore is accessible to many diverse patients.
Digital biomarkers must demonstrate VALIDITY: sensitivity to subtle change over time, but also relevance to an individual's daily life and function (i.e. veridicality and verisimilitude). Patient selfie videos capture activities relevant in daily life (buttoning a shirt, walking down a hallway, talking about one's morning), across all levels of disability, using assessments that are holistic and that have veridicality and verisimilitude. Furthermore, the metrics show greater sensitivity to change than standard assessments.
Overall objective: Validate video "selfies" as a patient-centered, valid, comprehensive longitudinal data collection method in MS. This approach will be deemed successful if the investigators achieve key metrics informed by implementation science and digital monitoring biomarker validation as necessary for dissemination, which surpass the feasibility, usability or validity of most digital tools currently available for monitoring in MS.
- Conditions
- Multiple Sclerosis, Multiple Sclerosis (MS) - Relapsing-remitting, Multiple Sclerosis (MS) Primary Progressive, MS (Multiple Sclerosis), MS, Multiple Sclerosis (MS) Secondary Progressive
- Keywords
- multiple sclerosis, MS, digital tool, UCSF
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic Progressive
What is being measured
The primary outcome is the main question the study is designed to answer.
Validate key metrics derived from video "selfies" against the MS Functional Composite (MSFC)
The investigators will optimize key metrics until they show at least 0.75 correlation coefficient with MSFC z scores, as well as individual domains (walking speed/Timed 25 foot walk, processing speed/Symbol digit modalities test, dexterity/9 hole peg test).
Measured: 1 year
Secondary outcomes (3)
Video acquisition protocol usability
The investigators will explore barriers and facilitators to adoption, and iteratively optimize outreach, instructions, video prompts, camera angles and uploading parameters so diverse PwMS can participate in research and care.
Measured: 1 year
Refine single-domain and composite video metrics
Aim 2. Refine single-domain and composite video metrics. Machine learning techniques will generate comprehensive single-domain and holistic metrics of patient functioning that: can be observed asynchronously by clinicians, recapitulate MSFC and EDSS, but are more relevant to daily life than standard metrics.
Measured: 1 year
Validate video metrics' sensitivity to subtle changes over time.
Aim 3. Validate video metrics' sensitivity to subtle changes over time. Over 12 months, the investigators will detect subtle worsening in substantially more patients than by existing single domain / global metrics (MSFC, EDSS), informing the tool's utility in measuring PIRA and response to neurorehabilitation, remyelination, and symptom management.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2025
- Study start1 Oct 2025
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
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.
- More trials run by University of California, San FranciscoThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Riley Bove, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07222618
- Sponsor's protocol ID
- 21-33227
- Status last verified
- Oct 2025
- First submitted
- 27 Oct 2025
- Last updated
- 31 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nylander A, Sisodia N, Henderson K, Wijangco J, Koshal K, Poole S, Dias M, Linz N, Troger J, Konig A, Hayward-Koennecke H, Pedotti R, Brown E, Halabi C, Staffaroni A, Bove R. From "invisible" to "audible": Features extracted during simple speech tasks classify patient-reported fatigue in multiple sclerosis. Mult Scler. 2025 Feb;31(2):231-241. doi: 10.1177/13524585241303855. Epub 2024 Dec 17.
PubMed 39690923Gopal A, Torres WO, Winawer I, Poole S, Balan A, Stuart HS, Fritz NE, Gelfand JM, Allen DD, Bove R. "Self-care selfies": Patient-uploaded videos capture meaningful changes in dexterity over 6 months. Ann Clin Transl Neurol. 2023 Dec;10(12):2394-2406. doi: 10.1002/acn3.51928. Epub 2023 Oct 25.
PubMed 37877622
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Selfie" Videos: A Novel, Patient-centered, Comprehensive Approach to Measuring Function in MS
- ClinicalTrials.gov ID
- NCT07222618
- Acronym / sponsor ID
- 21-33227
- Conditions
- Multiple Sclerosis, Multiple Sclerosis (MS) - Relapsing-remitting, Multiple Sclerosis (MS) Primary Progressive, MS (Multiple Sclerosis), MS, Multiple Sclerosis (MS) Secondary Progressive
- Keywords
- multiple sclerosis, MS, digital tool, UCSF
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 30 Oct 2025 (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 goal of this observational study is to validate a novel, cost-effective method for real-world assessment using patient-acquired "selfie" videos in people with multiple sclerosis. The investigators aim to prove the feasibility and validity of monitoring walking changes remotely through a truly patient-centered, low-burden, low-cost approach. The main question this study aims to answer is: do remotely collected walking and speech videos from a mobile phone match the information investigators can gather from an in person visit?
Participants will collect 5 "selfie" videos at baseline, 3 months, 6 months and 12 months (about 15 minutes every 3 months). They will also come in person at baseline, 6 months, and 12 months for in person data collection (about 1 hour per in person visit).
Detailed description
The investigators aim to validate a novel, cost-effective method for real-world assessment using patient-acquired "selfie" videos. The investigator's preliminary data demonstrate feasibility, validity and utility of this technology, which overcomes limitations of existing digital biomarkers and offers a truly patient-centered, low-burden approach to monitoring and treating diverse people with MS (PwMS). The investigators want to understand the barriers and facilitators to adoption of this approach, as well as the real-world validity and impact of the data generated. This will allow investigators to share the most accessible, generalizable and useful protocols and metrics with the MS community.
This approach to digital tool development prioritizes patients and clinicians. Indeed, the investigators leverage a tool used every day by the general population ("selfie" videos) that recapitulates clinicians' primary examination tool: observing how patients talk and walk.
This approach uses the patient's own device (device agnostic: including smartphones sold after 2010, as well as tablets, laptops or desktops with camera capture), without requiring proprietary software or technology, to collect "selfie" videos - which are ubiquitous in modern life - and provides a link to a secure web portal for simple uploading. The task minimizes burden: it is brief (5 <1min videos), can be done in individuals' own homes, requires no direct or indirect costs, and therefore is accessible to many diverse patients.
Digital biomarkers must demonstrate VALIDITY: sensitivity to subtle change over time, but also relevance to an individual's daily life and function (i.e. veridicality and verisimilitude). Patient selfie videos capture activities relevant in daily life (buttoning a shirt, walking down a hallway, talking about one's morning), across all levels of disability, using assessments that are holistic and that have veridicality and verisimilitude. Furthermore, the metrics show greater sensitivity to change than standard assessments.
Overall objective: Validate video "selfies" as a patient-centered, valid, comprehensive longitudinal data collection method in MS. This approach will be deemed successful if the investigators achieve key metrics informed by implementation science and digital monitoring biomarker validation as necessary for dissemination, which surpass the feasibility, usability or validity of most digital tools currently available for monitoring in MS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A diverse population of adults with MS
Key inclusion criteria (2 listed)
- Any patient with MS who is above the age of 18 yrs. Participants who are unable to consent for themselves must have a surrogate decision maker or LAR.
- Age > 18 yrs, EDSS - <6.5, own a video recording device (smartphone, tablet, camera etc).
Key exclusion criteria (1 listed)
- Patient unwilling to participate in the study. Participants unable to consent for themselves who do not have a surrogate decision maker or LAR.
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
Validate key metrics derived from video "selfies" against the MS Functional Composite (MSFC)
Time frame: 1 year
The investigators will optimize key metrics until they show at least 0.75 correlation coefficient with MSFC z scores, as well as individual domains (walking speed/Timed 25 foot walk, processing speed/Symbol digit modalities test, dexterity/9 hole peg test).
3 secondary outcomes
Video acquisition protocol usability
Time frame: 1 year
Refine single-domain and composite video metrics
Time frame: 1 year
Validate video metrics' sensitivity to subtle changes over time.
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2025.
- Background: PubMed 39690923Nylander A, Sisodia N, Henderson K, Wijangco J, Koshal K, Poole S, Dias M, Linz N, Troger J, Konig A, Hayward-Koennecke H, Pedotti R, Brown E, Halabi C, Staffaroni A, Bove R. From "invisible" to "audible": Features extracted during simple speech tasks classify patient-reported fatigue in multiple sclerosis. Mult Scler. 2025 Feb;31(2):231-241. doi: 10.1177/13524585241303855. Epub 2024 Dec 17.
- Background: PubMed 37877622Gopal A, Torres WO, Winawer I, Poole S, Balan A, Stuart HS, Fritz NE, Gelfand JM, Allen DD, Bove R. "Self-care selfies": Patient-uploaded videos capture meaningful changes in dexterity over 6 months. Ann Clin Transl Neurol. 2023 Dec;10(12):2394-2406. doi: 10.1002/acn3.51928. Epub 2023 Oct 25.
- 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.
Riley Bove, MD principal investigator
University of California, San Francisco
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 and Multiple Sclerosis (MS) - Relapsing-remitting, run by University of California, San Francisco 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 2 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: looking for participants now, as of the sponsor's last update on 31 Oct 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kyra Henderson, Study Coordinator (415-353-8053, kyra.henderson@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validate key metrics derived from video "selfies" against the MS Functional Composite (MSFC) (time frame: 1 year). 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 NCT07222618, 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 31 Oct 2025.