Performance and Safety of a Digital Tool for Unsupervised Self-assessment of NMOSD
Recruiting now · Not applicable
Conditions studied: Neuromyelitis Optica
In brief
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.
Key facts
- Study ID
- NCT05566769
- Run by
- Ad scientiam
- People needed
- 103
- Starts
- 2023-11-03
- Expected to finish
- 2026-09-01
- Last updated by the study team
- 2025-04-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Aged over 18 years old
- NMOSD as defined by the 2015 international consensus diagnostic criteria (AQP4+ only)
- With NMOSD treatment (treatment must be unchanged since 6 months before enrollment, and 1 month for analgesics, antidepressants, neuroleptics)
- EDSS =< 7
- With no evidence of relapse in the past 3 months before enrollment
- Who have read the information sheet and signed the informed consent form
- Able to use a smartphone
- Owns a personal smartphone which version is above 13 for IOS and 8 for Android included
- Able to read language in which the mobile application is available and able to understand pictograms
You may not qualify if…
- Evidence of neurologic, rheumatologic or psychiatric disorder other than NMOSD, including but not limited to major head trauma, seizures or systemic medical diseases that are likely to affect cognitive, upper limb or lower limb functioning
- Pregnant and nursing women
- Person under guardianship or curatorship
- Bedridden patients or patients with a daily activity of less than 2 hours per day
- Current drugs or/and alcohol abuse that could influence performance on the tests (clinician's judgment)
- Subject has participated in another clinical study within the previous 30 days of screening or is currently participating in another study that, in the opinion of the Investigator, might interfere with the participant's full participation in the study or confound the assessment of the participant or outcome of the study.
Where it is running
- University of Southern California — Los Angeles, California, United States (enrolling)
- University of California Davis Health — Sacramento, California, United States (enrolling)
- University of south Florida — Tampa, Florida, United States (enrolling)
- NorthShore University HealthSystem — Evanston, Illinois, United States (enrolling)
- Johns Hopkins Outpatient Center (now called Levi Watkins, Jr., M.D., Outpatient Center) — Baltimore, Maryland, United States (enrolling)
- Massachussets General Hospital — Boston, Massachusetts, United States (enrolling)
- Washington University in St. Louis — Washington, Missouri, United States (enrolling)
- CC Lou Ruvo Center for Brain Health — Las Vegas, Nevada, United States (enrolling)
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)
- Oklahoma Medical Research Foundation — Oklahoma City, Oklahoma, United States (enrolling)
- Hôpital Roger Salengro — Lille, France (enrolling)
- CHU Marseille - La Timone — Marseille, France (enrolling)
- CHU de Montpellier — Montpellier, France (enrolling)
- Hopital Pasteur 2 — Nice, France (enrolling)
- Hopital La Pitié Salpétrière — Paris, France (enrolling)
- Universitätsklinikum Carl Gustav Carus — Dresden, Germany (enrolling)
- Universitätsklinik Essen — Essen, Germany (enrolling)
- University Munich — Munich, Germany (enrolling)
- CHU Toulouse - Hôpital Purpan — Toulouse, France (enrolling)
- CHU Rouen — Rouen, France
- Hopital de Hautepierre — Strasbourg, France
- Hopital Rechts der Isar der Technischen Universitat Munchen — Munich, Germany
Full record on ClinicalTrials.gov
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