Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-26 @ 3:57 AM
Study NCT ID:
NCT07222618
Status:
RECRUITING
Last Update Posted:
2025-10-31
First Post:
2025-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
"Selfie" Videos: A Novel, Patient-centered, Comprehensive Approach to Measuring Function in MS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D020529', 'term': 'Multiple Sclerosis, Relapsing-Remitting'}, {'id': 'D020528', 'term': 'Multiple Sclerosis, Chronic Progressive'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2028-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-29', 'studyFirstSubmitDate': '2025-10-27', 'studyFirstSubmitQcDate': '2025-10-28', 'lastUpdatePostDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Validate key metrics derived from video "selfies" against the MS Functional Composite (MSFC)', 'timeFrame': '1 year', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Video acquisition protocol usability', 'timeFrame': '1 year', 'description': '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.'}, {'measure': 'Refine single-domain and composite video metrics', 'timeFrame': '1 year', 'description': '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.'}, {'measure': "Validate video metrics' sensitivity to subtle changes over time.", 'timeFrame': '1 year', 'description': "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."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['multiple sclerosis', 'MS', 'digital tool', 'UCSF'], 'conditions': ['Multiple Sclerosis', 'Multiple Sclerosis (MS) - Relapsing-remitting', 'Multiple Sclerosis (MS) Primary Progressive', 'MS (Multiple Sclerosis)', 'MS', 'Multiple Sclerosis (MS) Secondary Progressive']}, 'referencesModule': {'references': [{'pmid': '39690923', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '37877622', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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?\n\nParticipants 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).', 'detailedDescription': '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.\n\nThis 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.\n\nThis 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.\n\nDigital 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.\n\nOverall 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A diverse population of adults with MS', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* Age \\> 18 yrs, EDSS - \\<6.5, own a video recording device (smartphone, tablet, camera etc).\n\nExclusion Criteria:\n\n* Patient unwilling to participate in the study. Participants unable to consent for themselves who do not have a surrogate decision maker or LAR.'}, 'identificationModule': {'nctId': 'NCT07222618', 'briefTitle': '"Selfie" Videos: A Novel, Patient-centered, Comprehensive Approach to Measuring Function in MS', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': '"Selfie" Videos: A Novel, Patient-centered, Comprehensive Approach to Measuring Function in MS', 'orgStudyIdInfo': {'id': '21-33227'}}, 'contactsLocationsModule': {'locations': [{'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kyra Henderson, Study Coordinator', 'role': 'CONTACT', 'email': 'kyra.henderson@ucsf.edu', 'phone': '415-353-8053'}, {'name': 'Riley Bove, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'centralContacts': [{'name': 'Kyra Henderson, Study Coordinator', 'role': 'CONTACT', 'email': 'kyra.henderson@ucsf.edu', 'phone': '415-353-8053'}], 'overallOfficials': [{'name': 'Riley Bove, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}