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

October 29, 2025 updated by: University of California, San Francisco

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).

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94158
        • Recruiting
        • University of California, San Francisco
        • Principal Investigator:
          • Riley Bove, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

A diverse population of adults with MS

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Refine single-domain and composite video metrics
Time Frame: 1 year
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.
1 year
Video acquisition protocol usability
Time Frame: 1 year
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.
1 year
Validate video metrics' sensitivity to subtle changes over time.
Time Frame: 1 year
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

Genentech, Inc.

Investigators

  • Principal Investigator: Riley Bove, MD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2025

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

October 27, 2025

First Submitted That Met QC Criteria

October 28, 2025

First Posted (Estimated)

October 30, 2025

Study Record Updates

Last Update Posted (Estimated)

October 31, 2025

Last Update Submitted That Met QC Criteria

October 29, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-33227

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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