Performance and Safety of a Digital Tool for Unsupervised Self-assessment of NMOSD (NCT05566769)
Performance and Safety of a Digital Tool for Unsupervised Self-assessment of Neuromyelitis Optica Spectrum Disorder
🩺 Plain-English Summary (8th-Grade Level)
NMOSDCopilot is a digital tool developed for the self-assessment of Neuromyelitis Optica Spectrum Disorder symptoms that impact patients' functioning and quality of life. It has been co-designed with the help of patient advocacy groups, NMOSD patients and medical experts. It includes a smartphone-based application for patients, connected to a web portal developed for healthcare professionals (HCSPs). The patient application is composed of vision, walking, cognition, and dexterity e-active tests inspired by clinical standards, as well as e-questionnaires. The HCP web portal is a desktop-based software that allows HCPs to access the results generated via the patient application and facilitates remote monitoring of patients' symptoms. The objectives of this study are to validate the accuracy, reliability and reproducibility of the unsupervised at-home self-assessment of symptoms on the patient's smartphone versus the standard in-clinic testing, as well as to evaluate the safety of use of the tool, its usability, and satisfaction towards the patient application among NMOSD patients, and the HCP web dashboard among HCPs.
Who can join: Review the eligibility criteria below.
Location: University of Southern California — Los Angeles, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (22 Sites)
- University of Southern California — Los Angeles, California
- University of California Davis Health — Sacramento, California
- University of south Florida — Tampa, Florida
- NorthShore University HealthSystem — Evanston, Illinois
- Johns Hopkins Outpatient Center (now called Levi Watkins, Jr., M.D., Outpatient Center) — Baltimore, Maryland
- Massachussets General Hospital — Boston, Massachusetts
- Washington University in St. Louis — Washington, Missouri
- CC Lou Ruvo Center for Brain Health — Las Vegas, Nevada
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina
- Oklahoma Medical Research Foundation — Oklahoma City, Oklahoma
- Hôpital Roger Salengro — Lille,
- CHU Marseille - La Timone — Marseille,
- CHU de Montpellier — Montpellier,
- Hopital Pasteur 2 — Nice,
- Hopital La Pitié Salpétrière — Paris,
- CHU Rouen — Rouen,
- Hopital de Hautepierre — Strasbourg,
- CHU Toulouse - Hôpital Purpan — Toulouse,
- Universitätsklinikum Carl Gustav Carus — Dresden,
- Universitätsklinik Essen — Essen,
- University Munich — Munich,
- Hopital Rechts der Isar der Technischen Universitat Munchen — Munich,
📞 Contact the Study Coordinator
Phone: (617) 726-7565
Email: mlevy11@mgh.harvard.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.