Digital tool for self-assessing symptoms of Neuromyelitis Optica
Performance and Safety of a Digital Tool for Unsupervised Self-assessment of Neuromyelitis Optica Spectrum Disorder
NA · Ad scientiam · NCT05566769
This study is testing a smartphone app that helps people with Neuromyelitis Optica Spectrum Disorder track their symptoms to see if it works as well as traditional in-clinic assessments.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 103 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ad scientiam (other) |
| Locations | 22 sites (Los Angeles, California and 21 other locations) |
| Trial ID | NCT05566769 on ClinicalTrials.gov |
What this trial studies
This study evaluates NMOSDCopilot, a digital tool designed for patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) to self-assess their symptoms using a smartphone application. The app includes various e-active tests and questionnaires that measure vision, walking, cognition, and dexterity. Results from the app will be compared to standard in-clinic assessments to validate its accuracy and reliability. Additionally, the study aims to ensure the safety of using this tool for unsupervised self-assessment.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with a confirmed diagnosis of NMOSD who have stable treatment and can use a smartphone.
Not a fit: Patients with other significant neurological, rheumatological, or psychiatric disorders, or those who are bedridden, may not benefit from this study.
Why it matters
Potential benefit: If successful, this tool could empower patients to monitor their symptoms more effectively and improve their quality of life.
How similar studies have performed: Other studies have shown promise in using digital tools for patient self-assessment, indicating a growing interest in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Los Angeles, California and 21 other locations
- University of Southern California — Los Angeles, California, United States (RECRUITING)
- University of California Davis Health — Sacramento, California, United States (RECRUITING)
- University of south Florida — Tampa, Florida, United States (RECRUITING)
- NorthShore University HealthSystem — Evanston, Illinois, United States (RECRUITING)
- Johns Hopkins Outpatient Center (now called Levi Watkins, Jr., M.D., Outpatient Center) — Baltimore, Maryland, United States (RECRUITING)
- Massachussets General Hospital — Boston, Massachusetts, United States (RECRUITING)
- Washington University in St. Louis — Washington, Missouri, United States (RECRUITING)
- CC Lou Ruvo Center for Brain Health — Las Vegas, Nevada, United States (RECRUITING)
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (RECRUITING)
- Oklahoma Medical Research Foundation — Oklahoma City, Oklahoma, United States (RECRUITING)
- Hôpital Roger Salengro — Lille, France (RECRUITING)
- CHU Marseille - La Timone — Marseille, France (RECRUITING)
- CHU de Montpellier — Montpellier, France (RECRUITING)
- Hopital Pasteur 2 — Nice, France (RECRUITING)
- Hopital La Pitié Salpétrière — Paris, France (RECRUITING)
- CHU Rouen — Rouen, France (ACTIVE_NOT_RECRUITING)
- Hopital de Hautepierre — Strasbourg, France (COMPLETED)
- CHU Toulouse - Hôpital Purpan — Toulouse, France (RECRUITING)
- Universitätsklinikum Carl Gustav Carus — Dresden, Germany (RECRUITING)
- Universitätsklinik Essen — Essen, Germany (RECRUITING)
- University Munich — Munich, Germany (RECRUITING)
- Hopital Rechts der Isar der Technischen Universitat Munchen — Munich, Germany (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: Dr Levy
- Email: mlevy11@mgh.harvard.edu
- Phone: 617-726-7565
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Neuromyelitis Optica, NMO, NMOSD, Neuromyelitis optica, Neuromyelitis optica spectrum disorder