NMOSDCopilot App for Neuromyelitis Optica

(OPTIS Trial)

Recruiting at 20 trial locations

Overseen By Dr Levy

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ad scientiam

Must be taking: NMOSD treatment

Disqualifiers: Neurologic, Rheumatologic, Psychiatric disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

103 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{1 2 4 6 7}

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

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.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• NMOSDCopilot smartphone application

Trial Overview

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.

How Is the Trial Designed?

Group I: NMOSDCopilot Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Ad scientiam

Lead Sponsor

Trials

12

Recruited

1,500+

Published Research Related to This Trial

The CIRCLES study has successfully enrolled over 1,000 participants with neuromyelitis optica spectrum disorder (NMOSD), providing a valuable resource for understanding the disease's epidemiology and treatment, with 77.5% of cases still actively followed up.

Key findings from the study indicate that the majority of active NMOSD cases are female (84%) and anti-AQP4 seropositive (76%), with a median age of onset at 38.4 years and an annualized relapse rate of 0.5, highlighting demographic patterns that could inform future research and treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collaborative International Research in Clinical and Longitudinal Experience Study in NMOSD. Cook, LJ., Rose, JW., Alvey, JS., et al.[2023]

The N-MOmentum trial is investigating the safety and efficacy of MEDI-551, an anti-CD19 monoclonal antibody, in patients with neuromyelitis optica spectrum disorder (NMOSD), with a focus on minimizing patient exposure to placebo over a treatment period of up to 197 days.

This trial employs innovative statistical methods and interim analyses to ensure robust results while addressing the unique challenges of NMOSD clinical trials, aiming to accurately assess treatment effects and reduce risks for participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Statistical Considerations for an Adaptive Design for a Serious Rare Disease. Patra, K., Cree, BAC., Katz, E., et al.[2020]

The Brazilian Neuromyelitis Optica Database System (NMO-DBr) is a comprehensive database that collects and analyzes data from patients with neuromyelitis optica (NMO) and related disorders, enhancing the consistency of medical practice and research.

NMO-DBr includes detailed patient information such as symptoms, MRI results, and treatment history, while ensuring confidentiality and enabling statistical analysis, which can improve understanding and management of NMO.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

NMO-DBr: the Brazilian Neuromyelitis Optica Database System. Lana-Peixoto, MA., Talim, LE., Faria-Campos, AC., et al.[2019]

Neuromyelitis optica spectrum disorders (NMOSD) related optic neuritis (NMOSD-ON) can lead to permanent blindness and is characterized by a high rate of recurrence and poor prognosis, highlighting the need for effective treatment strategies.

Recent advancements in understanding the pathogenesis of NMOSD have led to the development of new therapeutic approaches aimed at both treating acute attacks and preventing relapses, offering hope for improved patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Progress in the treatment of neuromyelitis optica spectrum disorders related optic neuritis]. Song, HL., Xu, QG., Wei, SH.[2020]

A systematic review of 19 studies identified 410 cases of neuromyelitis optica spectrum disorder (NMOSD) in Africa, revealing a mean age of diagnosis at 33 years and a predominance of female patients (75%).

The most common symptoms at presentation were transverse myelitis and optic neuritis, with treatment primarily involving IV methylprednisolone for relapses and azathioprine for maintenance, highlighting the need for better data collection and healthcare access for NMOSD in Africa.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromyelitis Optica Spectrum Disorders in Africa: A Systematic Review. Musubire, AK., Derdelinckx, J., Reynders, T., et al.[2023]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05566769

NCT05566769 | Performance and Safety of a Digital Tool ...

NMOSDCopilot is a digital tool developed for the self-assessment of Neuromyelitis Optica Spectrum Disorder symptoms that impact patients' functioning and ...

2.

withpower.com

withpower.com/trial/phase-neuromyelitis-optica-1-2023-87703

NMOSDCopilot App for Neuromyelitis Optica (OPTIS Trial)

Key findings from the study indicate that the majority of active NMOSD cases are female (84%) and anti-AQP4 seropositive (76%), with a median age of onset at ...

3.

vjneurology.com

vjneurology.com/video/v_o29etuzze-nmosdcopilot-smartphone-based-digital-biomarkers/

AAN 2023 | NMOSDCopilot: smartphone-based digital ...

NMOSDCopilot is a mobile app that tracks the progress of patients with neuromyelitis optica spectrum disorder (NMOSD). Michael Levy, MD, PhD, Massachusetts ...

4.

neurology.org

neurology.org/doi/10.1212/WNL.0000000000205132

Validation Process of NMOSDCopilotTM, a Software as ...

Objective:To describe the results of the validation process of NMOSDCopilot™ through an usability evaluation, and the design of the OPTIS ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7365197/

Inpatient Multidisciplinary Rehabilitation Intervention ...

Multidisciplinary rehabilitation may improve functional recovery after NMOSD attacks. Younger age and two or less attacks were associated with better outcomes ...

6.

ctv.veeva.com

ctv.veeva.com/study/performance-and-safety-of-a-digital-tool-for-unsupervised-self-assessment-of-nmosd

Performance and Safety of a Digital Tool for Unsupervised ...

NMOSDCopilot is a digital tool developed for the self-assessment of Neuromyelitis Optica Spectrum Disorder symptoms that impact patients' ...

7.

clinconnect.io

clinconnect.io/trials/NCT05566769

Performance and Safety of a Digital Tool for - ClinConnect

NMOSDCopilot is a digital tool developed for the self-assessment of Neuromyelitis Optica Spectrum Disorder symptoms that impact patients' functioning and ...