"Selfie" Videos: A Novel, Patient-centered, Comprehensive Approach to Measuring Function in MS

NCT ID: NCT07222618

Last Updated: 2025-10-31

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2028-10-01

Brief 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. 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.

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 Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

• Patient unwilling to participate in the study. Participants unable to consent for themselves who do not have a surrogate decision maker or LAR.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Riley Bove, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kyra Henderson, Study Coordinator

Role: CONTACT

Phone: 415-353-8053

Email: kyra.henderson@ucsf.edu

Facility Contacts

Kyra Henderson, Study Coordinator

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 39690923 (View on PubMed)

Gopal 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.

Reference Type: BACKGROUND

PMID: 37877622 (View on PubMed)

Other Identifiers

21-33227

Identifier Type: -

Identifier Source: org_study_id