NMOSDCopilot App for Neuromyelitis Optica
(OPTIS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new smartphone app designed to help individuals with Neuromyelitis Optica Spectrum Disorder (NMOSD) track their symptoms at home. The app, NMOSDCopilot, enables users to perform tests related to vision, walking, thinking, and hand movements, while healthcare professionals monitor results remotely through a web portal. The study aims to determine if the app's home results are as reliable as in-clinic tests and to evaluate the app's user-friendliness and safety. Suitable participants have NMOSD confirmed by specific criteria, have maintained stable treatment for six months, and have not experienced a recent relapse. Participants must be comfortable using a smartphone that meets the app's requirements. As an unphased trial, this study offers a unique opportunity to contribute to innovative technology that could enhance daily life for those with NMOSD.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it requires that your NMOSD treatment has not changed in the last 6 months, and analgesics, antidepressants, and neuroleptics have not changed in the last month.
What prior data suggests that the NMOSDCopilot app is safe for use?
Research shows that the NMOSDCopilot smartphone app is undergoing tests to determine its safety and effectiveness in helping people with Neuromyelitis Optica Spectrum Disorder (NMOSD) track their symptoms. This digital tool allows users to monitor symptoms like vision and walking from home.
As an app rather than a medicine, the focus is on usability and user satisfaction, not side effects. Current studies are evaluating the app's effectiveness and user-friendliness. So far, no reports of harm or negative effects have emerged, suggesting it is likely well-tolerated.
Testing continues to ensure the app functions as intended and is easy for patients to use regularly. For those considering joining the study, this indicates the app is likely safe, with an emphasis on aiding NMOSD symptom management.12345Why are researchers excited about this trial?
Researchers are excited about the NMOSDCopilot app because it introduces a novel, digital approach to managing neuromyelitis optica, a rare autoimmune condition typically treated with immunosuppressive medications. Unlike traditional treatments that focus on medication, NMOSDCopilot offers continuous at-home monitoring and self-management tools through a smartphone app. This digital solution allows patients to perform tests and track their symptoms between clinic visits, potentially improving disease management and enhancing patient engagement. By empowering patients with real-time data and insights, NMOSDCopilot could lead to more personalized and timely interventions, which is a significant advancement over current treatment options.
What evidence suggests that the NMOSDCopilot app is effective for self-assessing Neuromyelitis Optica symptoms?
Research shows that NMOSDCopilot, the investigational treatment in this trial, is a promising digital tool for people with Neuromyelitis Optica Spectrum Disorder (NMOSD). This app helps users track symptoms like vision problems, difficulty walking, and trouble with thinking or hand movements. Early results suggest that the app's self-checks align well with standard clinical tests, indicating it might provide accurate results from home. Developers created the tool with feedback from NMOSD patients and healthcare professionals to enhance symptom tracking's ease and reliability. Such digital tools could improve patient care by enabling continuous monitoring and potentially detecting symptom changes early.12467
Are You a Good Fit for This Trial?
This trial is for adults aged 18-60 with Neuromyelitis Optica (NMO), specifically AQP4+ diagnosed by the 2015 criteria. Participants must be stable on treatment for at least 6 months, have an EDSS score of ≤7, and no relapses in the past 3 months. They need to own a compatible smartphone and understand the app's language.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Initial in-clinic assessment and performance of digital tests and standard tests
At-home Self-assessment
Participants use the NMOSDCopilot application for unsupervised self-assessment of symptoms
In-clinic Follow-up Assessments
In-clinic assessments to compare with at-home results and evaluate safety, usability, and satisfaction
Follow-up
Participants are monitored for safety and effectiveness after the main assessment period
What Are the Treatments Tested in This Trial?
Interventions
- NMOSDCopilot smartphone application
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ad scientiam
Lead Sponsor