An interventional study of NMOSDCopilot smartphone application in Neuromyelitis Optica, sponsored by Ad scientiam. Recruiting at 22 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-10.
Sponsored by Ad scientiam · Not applicable, Interventional, and Other
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 patient's smartphone versus the standard in-clinic testing, as well as to evaluate the safety of use of the tool, its usability, and satisfaction towards the patient application among NMOSD patients, and the HCP web dashboard among HCPs.
178 studies on the registry are indexed under Neuromyelitis Optica; 78 are open to participants now.
This study's planned enrollment of 103 is above the median of 29 across 108 interventional studies indexed under Neuromyelitis Optica.
Browse Neuromyelitis Optica studies →Ad scientiam is the lead sponsor of 14 studies on the registry; 5 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Performance of digital tests and standard test in clinic at D0 and M6 Use of NMOSDCopilot at-home in between visits during 12 months
Device: NMOSDCopilot smartphone application
NMOSDCopilot includes active tests for walking, cognition, dexterity and vision, and e-questionnaires related to pain, fatigue, quality of life, bladder and bowel dysfunction, depression
To compare results obtained with unsupervised at-home e-active tests and the corresponding supervised in-clinic standard tests, test to test
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
Time frame: Standard tests results at Baseline versus e-active tests results at D0 + 7 days
To assess reproducibility between in-clinic and at-home e-active tests
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 and between and month 6 and month 6- 7days
Time frame: Baseline, day 7, month 6 - 7 days, month 6
To assess test-retest reliability of at-home e-active tests
Intraclass correlation coefficient of e-active tests
Time frame: Month 1, month 2, month 3, month 4, month 5
To compare results obtained with in-clinic e-active tests and in-clinic standard tests, test to test
Pearson's correlation coefficient of inc-clinic e-active tests and in-clinic standard tests
Time frame: Baseline, month 6, month 12
To assess the adverse events related to of the mobile application use.
descriptive analysis of adverse events (AEs) related to the use of the application.
Time frame: through study completion, 21 months
To assess pain
Pain Visual Analogue Scale (0-100) higher score meaning a worse outcome
Time frame: Month 3, month 6, month 12
To assess fatigue
Modified Fatigue Impact Scale 5 (0-20) higher score meaning a worse outcome
Time frame: Month 3, month 6, month 12
To assess bladder control
Bladder Control Scale (0-22) higher score meaning a worse outcome
Time frame: Month 3, month 6, month 12
To assess bowel control
Bowel Control Scale (0-22) higher score meaning a worse outcome
Time frame: Month 3, month 6, month 12
To assess depression
Patient Health Questionnaire-8 (0-12) higher score meaning a worse outcome
Time frame: Month 3, month 6, month 12
To assess quality of life
p-value of multivariate analysis for non-parametric data
Time frame: Baseline, month 6, month 12
To assess disability
Expanded Disability Status Scale (0-10), higher score meaning a worse outcome
Time frame: Baseline, month 6, month 12
To assess satisfaction and user experience with the smartphone application and the web dashboard
Descriptive analysis of satisfaction and user experience questionnaires (System Usability Scale (1-100) higher score meaning a better outcome)
Time frame: Through study completion, 21 months
To assess at-home compliance and adherence to the patient application
Descriptive analysis of the mobile application's adherence data (number of completed questionnaires, number of sessions performed etc.).
Time frame: Through study completion, 21 months
To compare results obtained with at home MVT and in-clinic OCT-scan
The Pearson's correlation coefficient will be used to assess the relation between MVT e-active test at D0 +7 (home) versus standard OCT-scan test at D0 (in clinic). The minimum coefficient to reach is 0.65 to show that low contrast visual acuity measurement is associated with. RNF \& GCIP layer thickness
Time frame: Through study completion, 21 months
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Plan to share: No
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Started Nov 2023 (actual). Primary completion is estimated for Sep 2025, 22 months after the start.
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