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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05566769
Other study ID # OPTIS
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 3, 2023
Est. completion date July 1, 2025

Study information

Verified date March 2024
Source Ad scientiam
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 103
Est. completion date July 1, 2025
Est. primary completion date November 3, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Aged 18 to 60 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
France Hôpital Roger Salengro Lille
France CHU de Montpellier Montpellier
France Hopital Pasteur 2 Nice
France Hopital La Pitié Salpétrière Paris
France CHU Rouen Rouen
France Hopital de Hautepierre Strasbourg
United States Johns Hopkins Outpatient Center (now called Levi Watkins, Jr., M.D., Outpatient Center) Baltimore Maryland
United States Massachussets General Hospital Boston Massachusetts
United States NorthShore University HealthSystem Evanston Illinois
United States CC Lou Ruvo Center for Brain Health Las Vegas Nevada
United States Oklahoma Medical Research Foundation Oklahoma City Oklahoma
United States University of south Florida Tampa Florida
United States Washington University in St. Louis Washington Missouri

Sponsors (1)

Lead Sponsor Collaborator
Ad scientiam

Countries where clinical trial is conducted

United States,  France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Standard tests results at Baseline versus e-active tests results at D0 + 7 days
Secondary 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 Baseline, day 7, month 6 - 7 days, month 6
Secondary To assess test-retest reliability of at-home e-active tests Intraclass correlation coefficient of e-active tests Month 1, month 2, month 3, month 4, month 5
Secondary 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 Baseline, month 6, month 12
Secondary 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. through study completion, 21 months
Secondary To assess pain Pain Visual Analogue Scale (0-100) higher score meaning a worse outcome Month 3, month 6, month 12
Secondary To assess fatigue Modified Fatigue Impact Scale 5 (0-20) higher score meaning a worse outcome Month 3, month 6, month 12
Secondary To assess bladder control Bladder Control Scale (0-22) higher score meaning a worse outcome Month 3, month 6, month 12
Secondary To assess bowel control Bowel Control Scale (0-22) higher score meaning a worse outcome Month 3, month 6, month 12
Secondary To assess depression Patient Health Questionnaire-8 (0-12) higher score meaning a worse outcome Month 3, month 6, month 12
Secondary To assess quality of life p-value of multivariate analysis for non-parametric data Baseline, month 6, month 12
Secondary To assess disability Expanded Disability Status Scale (0-10), higher score meaning a worse outcome Baseline, month 6, month 12
Secondary 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) Through study completion, 21 months
Secondary 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.). Through study completion, 21 months
Secondary 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 Through study completion, 21 months
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