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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Neuromyelitis Optica
• Intervention / Treatment: Device: NMOSDCopilot smartphone application

• Study Type: Interventional
• Enrollment (Estimated): 103
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France, 59037
    • Recruiting
    • Hôpital Roger Salengro
    • Contact: Helene Zephir, Pr; Phone Number: 03 20 44 59 62; Email: Helene.ZEPHIR@chu-lille.fr
  • Montpellier, France, 34295
    • Recruiting
    • CHU de Montpellier
    • Contact: Pierre Labauge, Pr; Phone Number: 04 67 33 94 69; Email: p-labauge@chu-montpellier.fr
  • Nice, France, 06000
    • Recruiting
    • Hopital Pasteur 2
    • Contact: Michael Cohen, Dr; Phone Number: 04 92 03 77 77; Email: cohen.m@chu-nice.fr
  • Paris, France
    • Recruiting
    • Hôpital La Pitié Salpétrière
    • Contact: Elisabeth Maillart, Dr; Phone Number: 01 42 17 62 05; Email: elisabeth.maillart@aphp.fr
  • Rouen, France, 76038
    • Recruiting
    • CHU Rouen
    • Contact: Bertrand Bourre, Dr; Phone Number: 02 32 88 89 90; Email: Bertrand.Bourre@chu-rouen.fr
  • Strasbourg, France, 67000
    • Recruiting
    • Hopital de Hautepierre
    • Contact: Jérôme De Sèze, Pr; Phone Number: 03 88 12 85 91; Email: Jerome.DESEZE@chru-strasbourg.fr
    • Principal Investigator: Jérôme DE SEZE
• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • Recruiting
      • University of South Florida
      • Contact: John Ciotti, MD; Phone Number: 813-396-9478; Email: jciotti@usf.edu
  • Illinois
    • Evanston, Illinois, United States, 60201
      • Recruiting
      • NorthShore University HealthSystem
      • Contact: Afif Hentati, MD; Phone Number: 847-570-2570; Email: AHentati@northshore.org
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • Johns Hopkins Outpatient Center (now called Levi Watkins, Jr., M.D., Outpatient Center)
      • Contact: Elias S Sotirchos; Phone Number: 410-614-1522; Email: ess@jhmi.edu
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachussets General Hospital
      • Contact: Michael Levy, MD, PhD; Phone Number: 617-726-7565; Email: MLEVY11@mgh.harvard.edu
  • Missouri
    • Washington, Missouri, United States, 63130
      • Recruiting
      • Washington University in St. Louis
      • Contact: Robert T Naismith, MD; Phone Number: 314-362-3293; Email: naismithr@wustl.edu
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Recruiting
      • CC Lou Ruvo Center for Brain Health
      • Contact: Le Hua, MD; Phone Number: 702-483-6000; Email: Hual@ccf.org
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Recruiting
      • Oklahoma Medical Research Foundation
      • Contact: Gabriel Pardo, MD; Phone Number: 405-271-6673; Email: gabriel-pardo@omrf.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NMOSDCopilot; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
To assess pain	Pain Visual Analogue Scale (0-100) higher score meaning a worse outcome	Month 3, month 6, month 12
To assess fatigue	Modified Fatigue Impact Scale 5 (0-20) higher score meaning a worse outcome	Month 3, month 6, month 12
To assess bladder control	Bladder Control Scale (0-22) higher score meaning a worse outcome	Month 3, month 6, month 12
To assess bowel control	Bowel Control Scale (0-22) higher score meaning a worse outcome	Month 3, month 6, month 12
To assess depression	Patient Health Questionnaire-8 (0-12) higher score meaning a worse outcome	Month 3, month 6, month 12
To assess quality of life	p-value of multivariate analysis for non-parametric data	Baseline, month 6, month 12
To assess disability	Expanded Disability Status Scale (0-10), higher score meaning a worse outcome	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)	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.).	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	Through study completion, 21 months

Collaborators and Investigators

• Sponsor: Ad scientiam

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2023
• Primary Completion (Estimated): November 3, 2024
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: September 7, 2022
• First Submitted That Met QC Criteria: October 3, 2022
• First Posted (Actual): October 4, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Neuromyelitis optica spectrum disorder; NMO; Neuromyelitis optica; NMOSD
• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Eye Diseases; Optic Nerve Diseases; Cranial Nerve Diseases; Myelitis, Transverse; Optic Neuritis; Neuromyelitis Optica
• Other Study ID Numbers: OPTIS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes