Actively Recruiting
Performance and Safety of a Digital Tool for Unsupervised Self-assessment of NMOSD
Led by Ad scientiam · Updated on 2025-04-10
103
Participants Needed
22
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Performance and Safety of a Digital Tool for Unsupervised Self-assessment of NMOSD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged over 18 years old
- Diagnosed with NMOSD as defined by the 2015 international consensus diagnostic criteria (AQP4+ only)
- Receiving NMOSD treatment unchanged for at least 6 months before enrollment
- Analgesics, antidepressants, or neuroleptics treatment unchanged for at least 1 month before enrollment
- Expanded Disability Status Scale (EDSS) score less than or equal to 7
- No evidence of relapse in the 3 months before enrollment
- Have read the information sheet and signed informed consent
- Able to use a smartphone
- Own a personal smartphone with iOS version 13 or higher or Android version 8 or higher
- Able to read the language of the mobile application and understand pictograms
You will not qualify if you...
- Have neurologic, rheumatologic, or psychiatric disorders other than NMOSD that affect cognition or limb function
- Pregnant or nursing women
- Under guardianship or curatorship
- Bedridden or with less than 2 hours of daily activity
- Current drug or alcohol abuse affecting test performance
- Participated in another clinical study within 30 days before screening or currently enrolled in a conflicting study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 22 locations
1
University of Southern California
Los Angeles, California, United States, 90033
Actively Recruiting
2
University of California Davis Health
Sacramento, California, United States, 95817
Actively Recruiting
3
University of south Florida
Tampa, Florida, United States, 33612
Actively Recruiting
4
NorthShore University HealthSystem
Evanston, Illinois, United States, 60201
Actively Recruiting
5
Johns Hopkins Outpatient Center (now called Levi Watkins, Jr., M.D., Outpatient Center)
Baltimore, Maryland, United States, 21287
Actively Recruiting
6
Massachussets General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
7
Washington University in St. Louis
Washington, Missouri, United States, 63130
Actively Recruiting
8
CC Lou Ruvo Center for Brain Health
Las Vegas, Nevada, United States, 89106
Actively Recruiting
9
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
10
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
11
Hôpital Roger Salengro
Lille, France, 59037
Actively Recruiting
12
CHU Marseille - La Timone
Marseille, France, 13385
Actively Recruiting
13
CHU de Montpellier
Montpellier, France, 34295
Actively Recruiting
14
Hopital Pasteur 2
Nice, France, 06000
Actively Recruiting
15
Hopital La Pitié Salpétrière
Paris, France
Actively Recruiting
16
CHU Rouen
Rouen, France, 76038
Active, Not Recruiting
17
Hopital de Hautepierre
Strasbourg, France, 67000
Completed
18
CHU Toulouse - Hôpital Purpan
Toulouse, France, 31059
Actively Recruiting
19
Universitätsklinikum Carl Gustav Carus
Dresden, Germany, 01397
Actively Recruiting
20
Universitätsklinik Essen
Essen, Germany, 45147
Actively Recruiting
21
University Munich
Munich, Germany, 80336
Actively Recruiting
22
Hopital Rechts der Isar der Technischen Universitat Munchen
Munich, Germany
Not Yet Recruiting
Research Team
D
Dr Levy
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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