IA Trial Radar | ||
|---|---|---|
L'essai clinique NCT05566769 (OPTIS) pour Neuromyélite optique est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
Un essai clinique correspond aux filtres sélectionnés
Vue en carte
Performance and Safety of a Digital Tool for Unsupervised Self-assessment of NMOSD (OPTIS)
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'essai' pour voir et discuter des informations sur l'essai dans la langue sélectionnée.
L'étude clinique NCT05566769 (OPTIS) est un essai interventionnel pour Neuromyélite optique. Son statut actuel est : en recrutement. L'étude a débuté le 3 novembre 2023 et vise à recruter 103 participants. Dirigé par Ad scientiam, l'essai devrait être terminé d'ici le 1 septembre 2026. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 10 avril 2025.
Résumé succinct
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.
Titre officiel
Performance and Safety of a Digital Tool for Unsupervised Self-assessment of Neuromyelitis Optica Spectrum Disorder
Conditions
Neuromyélite optiqueAutres identifiants de l'essai
- OPTIS
Numéro NCT
Date de début (réel)
2023-11-03
Dernière mise à jour publiée
2025-04-10
Date de fin (estimée)
2026-09
Inscription (estimée)
103
Type d'essai
Interventionnel
PHASE
N/A
Statut
En recrutement
Mots clés
NMO
NMOSD
Neuromyelitis optica
Neuromyelitis optica spectrum disorder
NMOSD
Neuromyelitis optica
Neuromyelitis optica spectrum disorder
Objectif principal
Autre
Plan d'attribution
N/A
Modèle d'intervention
Groupe unique
Masquage
Aucun (ouvert)
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalNMOSDCopilot Performance of digital tests and standard test in clinic at D0 and M6 Use of NMOSDCopilot at-home in between visits during 12 months | 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 |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
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 |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
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 |
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
- 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
- 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.
Ad scientiamContact central de l'essai
Contact: Dr Levy, 617-726-7565, [email protected]
22 Centres de l'essai dans 3 pays
Hôpital Roger Salengro, Lille, 59037, France
Helene Zephir, Pr, Contact, 03 20 44 59 62, [email protected]
En recrutement
CHU Marseille - La Timone, Marseille, 13385, France
Dr Maarouf, Contact, 04.91.38.00.00, [email protected]
Dr Maarouf, Investigateur principal
En recrutement
CHU de Montpellier, Montpellier, 34295, France
Pierre Labauge, Pr, Contact, 04 67 33 94 69, [email protected]
En recrutement
Hopital Pasteur 2, Nice, 06000, France
Michael Cohen, Dr, Contact, 04 92 03 77 77, [email protected]
En recrutement
Hopital La Pitié Salpétrière, Paris, France
Elisabeth Maillart, Dr, Contact, 01 42 17 62 05, [email protected]
En recrutement
CHU Rouen, Rouen, 76038, France
Actif, pas en recrutement
Hopital de Hautepierre, Strasbourg, 67000, France
Terminé
CHU Toulouse - Hôpital Purpan, Toulouse, 31059, France
Dr Ciron, Contact, +33 5 61 77 91 06, [email protected]
Dr Ciron, Investigateur principal
En recrutement
California
University of Southern California, Los Angeles, California, 90033, United States
Dr Lilyana Amezcua, Contact, 323 442-5710, [email protected]
Dr Amezcua, Investigateur principal
En recrutement
University of California Davis Health, Sacramento, California, 95817, United States
Dr Apperson, Contact, 800 282 3284, [email protected]
Dr Apperson, Investigateur principal
En recrutement
Florida
University of south Florida, Tampa, Florida, 33612, United States
John Ciotti, MD, Contact, 8133969478, [email protected]
Dr Ciotti, Investigateur principal
En recrutement
Illinois
NorthShore University HealthSystem, Evanston, Illinois, 60201, United States
Afif Hentati, MD, Contact, +1 847-570-2570, [email protected]
Dr Hentati, Investigateur principal
En recrutement
Maryland
Johns Hopkins Outpatient Center (now called Levi Watkins, Jr., M.D., Outpatient Center), Baltimore, Maryland, 21287, United States
Elias S Sotirchos, Contact, 410-614-1522, [email protected]
Dr Sotirchos, Investigateur principal
En recrutement
Massachusetts
Massachussets General Hospital, Boston, Massachusetts, 02114, United States
Michael Levy, MD, PhD, Contact, (617) 726-7565, [email protected]
Dr Levy, Investigateur principal
En recrutement
Missouri
Washington University in St. Louis, Washington, Missouri, 63130, United States
Robert T Naismith, MD, Contact, 314-362-3293, [email protected]
Dr Naismith, Investigateur principal
En recrutement
Nevada
CC Lou Ruvo Center for Brain Health, Las Vegas, Nevada, 89106, United States
Le Hua, MD, Contact, 7024836000, [email protected]
Dr Le Hua, Investigateur principal
En recrutement
North Carolina
University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, 27514, United States
Dr Dujmovic, Contact, 984 974-4401, [email protected]
Dr Dujmovic, Investigateur principal
En recrutement
Oklahoma
Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma, 73104, United States
Gabriel Pardo, MD, Contact, (405) 271-6673, [email protected]
En recrutement
Universitätsklinikum Carl Gustav Carus, Dresden, 01397, Germany
Dr Ziemssen, Contact, +49 (0) 351 458 7450, [email protected]
Dr Ziemssen, Investigateur principal
Dr Inojosa, Investigateur associé
En recrutement
Universitätsklinik Essen, Essen, 45147, Germany
Dr Pul, Contact, +49 201 / 723- 82382, [email protected]
Dr Pul, Investigateur principal
En recrutement
University Munich, Munich, 80336, Germany
Dr Havla, Contact, +49 89 4400 74781, [email protected]
Dr Havla, Investigateur principal
Dr Kumpfel, Investigateur associé
Dr Gerdes, Investigateur associé
En recrutement
Hopital Rechts der Isar der Technischen Universitat Munchen, Munich, Germany
Achim Berthele, Dr, Contact, +49 89 41400, [email protected]
Pas encore en recrutement