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RECRUITING
NCT05566769
NA

Performance and Safety of a Digital Tool for Unsupervised Self-assessment of NMOSD

Sponsor: Ad scientiam

View on ClinicalTrials.gov

Summary

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.

Official title: Performance and Safety of a Digital Tool for Unsupervised Self-assessment of Neuromyelitis Optica Spectrum Disorder

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

103

Start Date

2023-11-03

Completion Date

2026-09

Last Updated

2025-04-10

Healthy Volunteers

No

Interventions

DEVICE

NMOSDCopilot smartphone application

NMOSDCopilot includes active tests for walking, cognition, dexterity and vision, and e-questionnaires related to pain, fatigue, quality of life, bladder and bowel dysfunction, depression

Locations (22)

University of Southern California

Los Angeles, California, United States

University of California Davis Health

Sacramento, California, United States

University of south Florida

Tampa, Florida, United States

NorthShore University HealthSystem

Evanston, Illinois, United States

Johns Hopkins Outpatient Center (now called Levi Watkins, Jr., M.D., Outpatient Center)

Baltimore, Maryland, United States

Massachussets General Hospital

Boston, Massachusetts, United States

Washington University in St. Louis

Washington, Missouri, United States

CC Lou Ruvo Center for Brain Health

Las Vegas, Nevada, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Oklahoma Medical Research Foundation

Oklahoma City, Oklahoma, United States

Hôpital Roger Salengro

Lille, France

CHU Marseille - La Timone

Marseille, France

CHU de Montpellier

Montpellier, France

Hopital Pasteur 2

Nice, France

Hopital La Pitié Salpétrière

Paris, France

CHU Rouen

Rouen, France

Hopital de Hautepierre

Strasbourg, France

CHU Toulouse - Hôpital Purpan

Toulouse, France

Universitätsklinikum Carl Gustav Carus

Dresden, Germany

Universitätsklinik Essen

Essen, Germany

University Munich

Munich, Germany

Hopital Rechts der Isar der Technischen Universitat Munchen

Munich, Germany