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

Status: Recruiting
Location: See all (22) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
University of Southern California
RECRUITING
Los Angeles
University of California Davis Health
RECRUITING
Sacramento
Florida
University of south Florida
RECRUITING
Tampa
Illinois
NorthShore University HealthSystem
RECRUITING
Evanston
Massachusetts
Massachussets General Hospital
RECRUITING
Boston
Maryland
Johns Hopkins Outpatient Center (now called Levi Watkins, Jr., M.D., Outpatient Center)
RECRUITING
Baltimore
Missouri
Washington University in St. Louis
RECRUITING
Washington
North Carolina
University of North Carolina at Chapel Hill
RECRUITING
Chapel Hill
Nevada
CC Lou Ruvo Center for Brain Health
RECRUITING
Las Vegas
Oklahoma
Oklahoma Medical Research Foundation
RECRUITING
Oklahoma City
Other Locations
France
Hôpital Roger Salengro
RECRUITING
Lille
CHU Marseille - La Timone
RECRUITING
Marseille
CHU de Montpellier
RECRUITING
Montpellier
Hopital Pasteur 2
RECRUITING
Nice
Hopital La Pitié Salpétrière
RECRUITING
Paris
CHU Rouen
ACTIVE_NOT_RECRUITING
Rouen
Hopital de Hautepierre
COMPLETED
Strasbourg
CHU Toulouse - Hôpital Purpan
RECRUITING
Toulouse
Germany
Universitätsklinikum Carl Gustav Carus
RECRUITING
Dresden
Universitätsklinik Essen
RECRUITING
Essen
Hopital Rechts der Isar der Technischen Universitat Munchen
NOT_YET_RECRUITING
Munich
University Munich
RECRUITING
Munich
Contact Information
Primary
Dr Levy
mlevy11@mgh.harvard.edu
617-726-7565
Time Frame
Start Date: 2023-11-03
Estimated Completion Date: 2026-09
Participants
Target number of participants: 103
Treatments
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
Sponsors
Leads: Ad scientiam

This content was sourced from clinicaltrials.gov