NMOSDCopilot App for Neuromyelitis Optica
(OPTIS Trial)
Recruiting in Palo Alto (17 mi)
+19 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Ad scientiam
Must be taking: NMOSD treatment
Disqualifiers: Neurologic, Rheumatologic, Psychiatric disorders, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial is testing NMOSDCopilot, a digital tool for NMOSD patients to self-assess symptoms at home using a smartphone app. The app includes tests and questionnaires, and doctors can monitor the results through a web portal. The study aims to validate the tool's accuracy, reliability, safety, and user satisfaction.
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.
How is the NMOSDCopilot app treatment for neuromyelitis optica different from other treatments?
The NMOSDCopilot app is unique because it is a smartphone application designed to assist in managing neuromyelitis optica, unlike traditional treatments that focus on medication or physical interventions. This app may provide a novel way to track symptoms, manage treatment plans, and offer educational resources, which is different from standard drug therapies.
12345Eligibility Criteria
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
Able to read language in which the mobile application is available and understand pictograms
Able to use a smartphone
My condition has been stable for the last 3 months.
+6 more
Exclusion Criteria
I do not have major neurological, mental health issues, or severe injuries affecting my brain or limbs.
I am under legal guardianship or curatorship.
Pregnant and nursing women
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Baseline Assessment
Initial in-clinic assessment and performance of digital tests and standard tests
1 day
1 visit (in-person)
At-home Self-assessment
Participants use the NMOSDCopilot application for unsupervised self-assessment of symptoms
12 months
Remote monitoring
In-clinic Follow-up Assessments
In-clinic assessments to compare with at-home results and evaluate safety, usability, and satisfaction
21 months
Visits at month 3, month 6, month 12
Follow-up
Participants are monitored for safety and effectiveness after the main assessment period
4 weeks
Participant Groups
The NMOSDCopilot smartphone application is being tested for its ability to accurately assess NMO symptoms at home compared to standard in-clinic tests. The study will also evaluate safety, usability, and satisfaction with both patient app and healthcare professional web portal.
1Treatment groups
Experimental Treatment
Group I: NMOSDCopilotExperimental Treatment1 Intervention
Performance of digital tests and standard test in clinic at D0 and M6 Use of NMOSDCopilot at-home in between visits during 12 months
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Southern CaliforniaLos Angeles, CA
University of California Davis HealthSacramento, CA
University of North Carolina at Chapel HillChapel Hill, NC
Massachussets General HospitalBoston, MA
More Trial Locations
Loading ...
Who Is Running the Clinical Trial?
Ad scientiamLead Sponsor
References
[Progress in the treatment of neuromyelitis optica spectrum disorders related optic neuritis]. [2020]Neuromyelitis optica spectrum disorders (NMOSD) related optic neuritis (NMOSD-ON) is a common neuro-ophthalmic disease which often results in permanent blindness. NMOSD is characterized by high recurrence rate and poor prognosis. Therefore the two key objectives of the therapeutic approach for patients with NMOSD are treatment of the acute attacks and prevention of the relapses. With the in-depth study of the pathogenesis of NMOSD, new treatments developed for different stages of the disease are emerging. This review gives an update of latest knowledge of NMOSD-ON, emphasizing both current and future therapeutic approaches. (Chin J Ophthalmol, 2020, 56: 539-543).
Collaborative International Research in Clinical and Longitudinal Experience Study in NMOSD. [2023]To develop a resource of systematically collected, longitudinal clinical data and biospecimens for assisting in the investigation into neuromyelitis optica spectrum disorder (NMOSD) epidemiology, pathogenesis, and treatment.
Neuromyelitis Optica Spectrum Disorders in Africa: A Systematic Review. [2023]Neuromyelitis optica (NMO) is a CNS inflammatory disease that predominantly affects the optic nerves and the spinal cord. It is more frequent in Asian and African populations than in European ones. Data on epidemiology, clinical presentation, additional investigations, and treatment in the African continent are scarce. We aim to (1) collect and analyze published data on neuromyelitis optica spectrum disorder (NMOSD), (2) indicate challenges in the diagnosis and management, and (3) discuss opportunities for future research, education, and policy making, specifically on the African continent.
Statistical Considerations for an Adaptive Design for a Serious Rare Disease. [2020]Neuromyelitis optica spectrum disorder (NMOSD) is a rare, disabling autoimmune disorder of the central nervous system. Clinical trials in NMOSD present unique design and statistical challenges to adequately determine treatment effect and to minimize risk.
NMO-DBr: the Brazilian Neuromyelitis Optica Database System. [2019]To present the Brazilian Neuromyelitis Optica Database System (NMO-DBr), a database system which collects, stores, retrieves, and analyzes information from patients with NMO and NMO-related disorders.