NCT05566769Recruiting
Performance and Safety of a Digital Tool for Unsupervised Self-assessment of NMOSD
Performance and Safety of a Digital Tool for Unsupervised Self-assessment of Neuromyelitis Optica Spectrum Disorder
Source: ClinicalTrials.gov · Last updated 10 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 103 (estimated)
- First submitted
- 7 Sept 2022
- Start date
- 3 Nov 2023
- Primary completion date
- Sept 2025
- Lead sponsor
- Ad scientiam
- Diseases
- Neuromyelitis optica (NMOSD)
- NCT number
- NCT05566769
What you commit to
- Study type: Interventional
- Planned participants: 103
- From 3 Nov 2023 to the primary completion date, Sept 2025
- 22 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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
Other
- Pregnant and nursing women
- Person under guardianship or curatorship
- Bedridden patients or patients with a daily activity of less than 2 hours per day
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (22)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitätsklinikum Carl Gustav Carus Coordinator of this site? Confirm its status | Dresden | Germany | Recruiting |
| Universitätsklinik Essen Coordinator of this site? Confirm its status | Essen | Germany | Recruiting |
| Hopital Rechts der Isar der Technischen Universitat Munchen Coordinator of this site? Confirm its status | Munich | Germany | Not yet recruiting |
| University Munich Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
| Hopital Roger Salengro Coordinator of this site? Confirm its status | Lille | France | Recruiting |
| CHU Marseille - La Timone Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| CHU de Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Recruiting |
| Hopital Pasteur 2 Coordinator of this site? Confirm its status | Nice | France | Recruiting |
| Hôpital La Pitié Salpetrière Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| CHU Rouen Coordinator of this site? Confirm its status | Rouen | France | Active, not recruiting |
| Hôpital de Hautepierre Coordinator of this site? Confirm its status | Strasbourg | France | Completed |
| CHU Toulouse - Hôpital Purpan Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
| Johns Hopkins Outpatient Center (now called Levi Watkins, Jr., M.D., Outpatient Center) Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| Massachussets General Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| University of North Carolina at Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Recruiting |
| NorthShore University HealthSystem Coordinator of this site? Confirm its status | Evanston | United States | Recruiting |
| CC Lou Ruvo Center for Brain Health Coordinator of this site? Confirm its status | Las Vegas | United States | Recruiting |
| University of Southern California Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Oklahoma Medical Research Foundation Coordinator of this site? Confirm its status | Oklahoma City | United States | Recruiting |
| University of California Davis Health Coordinator of this site? Confirm its status | Sacramento | United States | Recruiting |
| University of South Florida Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| Washington University in St. Louis Coordinator of this site? Confirm its status | Washington | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.