Digital tool for self-assessing symptoms of Neuromyelitis Optica

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Dr Levy
• Email: mlevy11@mgh.harvard.edu
• Phone: 617-726-7565

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.