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NCT Number: NCT05566769

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

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.

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Key information

Conditions

Neuromyelitis Optica Autoimmune Diseases Autoimmune Diseases of the Nervous System Cranial Nerve Diseases Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Eye Diseases Immune System Diseases Myelitis, Transverse Nervous System Diseases Optic Nerve Diseases Optic Neuritis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Roger Salengro, Lille, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NMOSDCopilot smartphone application

Device

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

Primary outcomes

  1. To compare results obtained with unsupervised at-home e-active tests and the corresponding supervised in-clinic standard tests, test to test

    Time frame: Standard 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

Secondary outcomes

  1. To assess reproducibility between in-clinic and at-home e-active tests

    Time frame: Baseline, day 7, month 6 - 7 days, month 6

    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

  2. To assess test-retest reliability of at-home e-active tests

    Time frame: Month 1, month 2, month 3, month 4, month 5

    Intraclass correlation coefficient of e-active tests

  3. To compare results obtained with in-clinic e-active tests and in-clinic standard tests, test to test

    Time frame: Baseline, month 6, month 12

    Pearson's correlation coefficient of inc-clinic e-active tests and in-clinic standard tests

  4. To assess the adverse events related to of the mobile application use.

    Time frame: through study completion, 21 months

    descriptive analysis of adverse events (AEs) related to the use of the application.

  5. To assess pain

    Time frame: Month 3, month 6, month 12

    Pain Visual Analogue Scale (0-100) higher score meaning a worse outcome

  6. To assess fatigue

    Time frame: Month 3, month 6, month 12

    Modified Fatigue Impact Scale 5 (0-20) higher score meaning a worse outcome

  7. To assess bladder control

    Time frame: Month 3, month 6, month 12

    Bladder Control Scale (0-22) higher score meaning a worse outcome

  8. To assess bowel control

    Time frame: Month 3, month 6, month 12

    Bowel Control Scale (0-22) higher score meaning a worse outcome

  9. To assess depression

    Time frame: Month 3, month 6, month 12

    Patient Health Questionnaire-8 (0-12) higher score meaning a worse outcome

  10. To assess quality of life

    Time frame: Baseline, month 6, month 12

    p-value of multivariate analysis for non-parametric data

  11. To assess disability

    Time frame: Baseline, month 6, month 12

    Expanded Disability Status Scale (0-10), higher score meaning a worse outcome

  12. To assess satisfaction and user experience with the smartphone application and the web dashboard

    Time frame: Through study completion, 21 months

    Descriptive analysis of satisfaction and user experience questionnaires (System Usability Scale (1-100) higher score meaning a better outcome)

  13. To assess at-home compliance and adherence to the patient application

    Time frame: Through study completion, 21 months

    Descriptive analysis of the mobile application's adherence data (number of completed questionnaires, number of sessions performed etc.).

  14. To compare results obtained with at home MVT and in-clinic OCT-scan

    Time frame: Through study completion, 21 months

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Dr Levy

CONTACT

[email protected]

617-726-7565

Sponsors and collaborators

Lead sponsor

Ad scientiam

Other

Registry information

Official study title

Performance and Safety of a Digital Tool for Unsupervised Self-assessment of Neuromyelitis Optica Spectrum Disorder

Acronym: OPTIS

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Oct 4, 2022
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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