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Digital Tool for NMOSD Self-Assessment

This study is testing a smartphone application called NMOSDCopilot. This app helps people with Neuromyelitis Optica Spectrum Disorder (NMOSD), a rare autoimmune disease that affects the brain and spinal cord, to self-assess their symptoms. The study wants to see how well the results from the app's tests (for walking, thinking, dexterity, and vision) compare to standard tests done in a clinic. To join, you must be over 18, have NMOSD (specifically AQP4+ type), be on stable NMOSD treatment for at least 6 months, and not have had a relapse in the past 3 months. The study aims to enroll 103 participants. The current status of the study is unclear.

Study design
This is an interventional study comparing results from a smartphone app to standard clinic tests. It plans to enroll 103 participants.
What's involved
You would use the NMOSDCopilot smartphone application for self-assessment. Your results from the app will be compared to standard clinic tests at baseline and 7 days later.
Compensation
Not stated in the trial record.
Follow-up
The primary comparison of test results is measured at baseline versus 7 days after using the e-active tests.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05566769

Performance and Safety of a Digital Tool for Unsupervised Self-assessment of NMOSD

Recruiting
NAAges 18+Interventional
Ad scientiam
~103 participants
Updated 2025-04-10 on ClinicalTrials.gov
What's tested:NMOSDCopilot smartphone application

At a glance

Recruiting sites
19 of 22 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To compare results obtained with unsupervised at-home e-active tests and the corresponding supervised in-clinic standard tests, test to test
Measured over Standard tests results at Baseline versus e-active tests results at D0 + 7 days

Conditions

Neuromyelitis Optica

Explore related trials

Neuromyelitis OpticaAQP4 Gene

Where it's being run

22 sites across 11 states
France8
Germany4
California2
Florida1
Illinois1
Maryland1
Massachusetts1
Missouri1

Who to contact

Dr Levy
[email protected]
617-726-7565
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • To compare results obtained with unsupervised at-home e-active tests and the corresponding supervised in-clinic standard tests, test to testStandard tests results at Baseline versus e-active tests results at D0 + 7 days

    Pearson correlation coefficient (or Spearman's rank-order correlation depending on the data distribution) between e-active tests at day 7 versus standard tests at baseline