NCT05566769

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 103 (estimated)
• Sponsor: Ad scientiam · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neuromyelitis Optica

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-11-03
• Primary completion: 2025-09-01
• Completion: 2026-09-01
• First posted: 2022-10-04
• Last updated: 2025-04-10

Locations

22 sites across 3 countries: United States, France, Germany

Regulatory

• FDA-regulated device study