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

Launched by AD SCIENTIAM · Oct 3, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new digital tool called NMOSDCopilot, designed to help people with Neuromyelitis Optica Spectrum Disorder (NMOSD) assess their symptoms from home. The tool includes a smartphone app that allows patients to perform simple tests related to their vision, walking, thinking, and hand movements, as well as answer questions about their health. The results are sent to healthcare professionals through a web portal, enabling them to monitor patients' symptoms remotely. The goal of the trial is to confirm that this at-home self-assessment is accurate and reliable compared to traditional in-clinic tests, while also ensuring that the tool is safe and easy to use.

To participate in this study, individuals need to be over 18 years old and diagnosed with NMOSD. They should have stable treatment for at least six months and be able to use a smartphone. Participants will not be eligible if they have other serious health conditions, are pregnant or nursing, or have recently participated in another clinical trial. If eligible, participants can expect to use the app to monitor their symptoms and provide feedback, contributing to the development of a tool that may improve the quality of life for others with NMOSD.

Gender

ALL

Eligibility criteria

• 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.