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NCT05566769Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 10 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
103 (estimated)
First submitted
7 Sept 2022
Start date
3 Nov 2023
Primary completion date
Sept 2025
Lead sponsor
Ad scientiam
NCT number
NCT05566769

What you commit to

  • Study type: Interventional
  • Planned participants: 103
  • From 3 Nov 2023 to the primary completion date, Sept 2025
  • 22 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • 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

Other

  • Pregnant and nursing women
  • Person under guardianship or curatorship
  • Bedridden patients or patients with a daily activity of less than 2 hours per day

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (22)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Universitätsklinikum Carl Gustav Carus
Coordinator of this site? Confirm its status
DresdenGermanyRecruiting
Universitätsklinik Essen
Coordinator of this site? Confirm its status
EssenGermanyRecruiting
Hopital Rechts der Isar der Technischen Universitat Munchen
Coordinator of this site? Confirm its status
MunichGermanyNot yet recruiting
University Munich
Coordinator of this site? Confirm its status
MunichGermanyRecruiting
Hopital Roger Salengro
Coordinator of this site? Confirm its status
LilleFranceRecruiting
CHU Marseille - La Timone
Coordinator of this site? Confirm its status
MarseilleFranceRecruiting
CHU de Montpellier
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MontpellierFranceRecruiting
Hopital Pasteur 2
Coordinator of this site? Confirm its status
NiceFranceRecruiting
Hôpital La Pitié Salpetrière
Coordinator of this site? Confirm its status
ParisFranceRecruiting
CHU Rouen
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RouenFranceActive, not recruiting
Hôpital de Hautepierre
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StrasbourgFranceCompleted
CHU Toulouse - Hôpital Purpan
Coordinator of this site? Confirm its status
ToulouseFranceRecruiting
Johns Hopkins Outpatient Center (now called Levi Watkins, Jr., M.D., Outpatient Center)
Coordinator of this site? Confirm its status
BaltimoreUnited StatesRecruiting
Massachussets General Hospital
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BostonUnited StatesRecruiting
University of North Carolina at Chapel Hill
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Chapel HillUnited StatesRecruiting
NorthShore University HealthSystem
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EvanstonUnited StatesRecruiting
CC Lou Ruvo Center for Brain Health
Coordinator of this site? Confirm its status
Las VegasUnited StatesRecruiting
University of Southern California
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Los AngelesUnited StatesRecruiting
Oklahoma Medical Research Foundation
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Oklahoma CityUnited StatesRecruiting
University of California Davis Health
Coordinator of this site? Confirm its status
SacramentoUnited StatesRecruiting
University of South Florida
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TampaUnited StatesRecruiting
Washington University in St. Louis
Coordinator of this site? Confirm its status
WashingtonUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.