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โ† Trials
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Performance and Safety of a Digital Tool for Unsupervised Self-assessment of NMOSD

RecruitingNAAges 18 Years - anyAllAd scientiam
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In plain words

What the trial is, and whether it could suit you

NMOSDCopilot is a digital tool developed for the self-assessment of Neuromyelitis Optica Spectrum Disorder symptoms that impact patients' functioning and quality of life. It has been co-designed with the help of patient advocacy groups, NMOSD patients and medical experts. It includes a smartphone-based application for patients, connected to a web portal developed for healthcare professionals (HCSPs). The patient application is composed of vision, walking, cognition, and dexterity e-active tests inspired by clinical standards, as well as e-questionnaires. The HCP web portal is a desktop-based software that allows HCPs to access the results generated via the patient application and facilitates remote monitoring of patients' symptoms. The objectives of this study are to validate the accuracy, reliability and reproducibility of the unsupervised at-home self-assessment of symptoms on the pat

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • NMOSDCopilot smartphone application
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Where

22 sites
University of Southern California
Los Angeles, United States
University of California Davis Health
Sacramento, United States
University of south Florida
Tampa, United States
NorthShore University HealthSystem
Evanston, United States
Johns Hopkins Outpatient Center (now called Levi Watkins, Jr., M.D., Outpatient Center)
Baltimore, United States
Massachussets General Hospital
Boston, United States
Washington University in St. Louis
Washington, United States
CC Lou Ruvo Center for Brain Health
Las Vegas, United States

โ€ฆand 14 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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