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

NCT05566769 · tracked via the Priya Life Science France tracker

Sponsor

Ad scientiam

Phase

Not applicable

Started

2023-11-03

Last updated

2025-04-10

Condition(s) studied

Neuromyelitis Optica

Investigational drug(s) / intervention(s)

NMOSDCopilot smartphone application

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

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

Primary outcome measure(s)

To compare results obtained with unsupervised at-home e-active tests and the corresponding supervised in-clinic standard tests, test to test — Standard tests results at Baseline versus e-active tests results at D0 + 7 days
Pearson correlation coefficient (or Spearman's rank-order correlation depending on the data distribution) between e-active tests at day 7 versus standard tests at baseline

Trial sites (22)

Facility	City	Region	Status
University of Southern California	Los Angeles	California	Recruiting
University of California Davis Health	Sacramento	California	Recruiting
University of south Florida	Tampa	Florida	Recruiting
NorthShore University HealthSystem	Evanston	Illinois	Recruiting
Johns Hopkins Outpatient Center (now called Levi Watkins, Jr., M.D., Outpatient Center)	Baltimore	Maryland	Recruiting
Massachussets General Hospital	Boston	Massachusetts	Recruiting
Washington University in St. Louis	Washington	Missouri	Recruiting
CC Lou Ruvo Center for Brain Health	Las Vegas	Nevada	Recruiting
University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	Recruiting
Oklahoma Medical Research Foundation	Oklahoma City	Oklahoma	Recruiting
Hôpital Roger Salengro	Lille	France	Recruiting
CHU Marseille - La Timone	Marseille	France	Recruiting
CHU de Montpellier	Montpellier	France	Recruiting
Hopital Pasteur 2	Nice	France	Recruiting
Hopital La Pitié Salpétrière	Paris	France	Recruiting
CHU Rouen	Rouen	France	Active Not Recruiting
Hopital de Hautepierre	Strasbourg	France	Completed
CHU Toulouse - Hôpital Purpan	Toulouse	France	Recruiting
Universitätsklinikum Carl Gustav Carus	Dresden	Germany	Recruiting
Universitätsklinik Essen	Essen	Germany	Recruiting
University Munich	Munich	Germany	Recruiting
Hopital Rechts der Isar der Technischen Universitat Munchen	Munich	Germany	Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05566769 on ClinicalTrials.gov ↗ ← All trials in France