Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-02-23 @ 8:06 PM
Study NCT ID:
NCT05566769
Status:
RECRUITING
Last Update Posted:
2025-04-10
First Post:
2022-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Performance and Safety of a Digital Tool for Unsupervised Self-assessment of NMOSD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009471', 'term': 'Neuromyelitis Optica'}], 'ancestors': [{'id': 'D009188', 'term': 'Myelitis, Transverse'}, {'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009902', 'term': 'Optic Neuritis'}, {'id': 'D009901', 'term': 'Optic Nerve Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'One group'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 103}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-08', 'studyFirstSubmitDate': '2022-09-07', 'studyFirstSubmitQcDate': '2022-10-03', 'lastUpdatePostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare results obtained with unsupervised at-home e-active tests and the corresponding supervised in-clinic standard tests, test to test', 'timeFrame': 'Standard tests results at Baseline versus e-active tests results at D0 + 7 days', 'description': "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"}], 'secondaryOutcomes': [{'measure': 'To assess reproducibility between in-clinic and at-home e-active tests', 'timeFrame': 'Baseline, day 7, month 6 - 7 days, month 6', 'description': "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"}, {'measure': 'To assess test-retest reliability of at-home e-active tests', 'timeFrame': 'Month 1, month 2, month 3, month 4, month 5', 'description': 'Intraclass correlation coefficient of e-active tests'}, {'measure': 'To compare results obtained with in-clinic e-active tests and in-clinic standard tests, test to test', 'timeFrame': 'Baseline, month 6, month 12', 'description': "Pearson's correlation coefficient of inc-clinic e-active tests and in-clinic standard tests"}, {'measure': 'To assess the adverse events related to of the mobile application use.', 'timeFrame': 'through study completion, 21 months', 'description': 'descriptive analysis of adverse events (AEs) related to the use of the application.'}, {'measure': 'To assess pain', 'timeFrame': 'Month 3, month 6, month 12', 'description': 'Pain Visual Analogue Scale (0-100) higher score meaning a worse outcome'}, {'measure': 'To assess fatigue', 'timeFrame': 'Month 3, month 6, month 12', 'description': 'Modified Fatigue Impact Scale 5 (0-20) higher score meaning a worse outcome'}, {'measure': 'To assess bladder control', 'timeFrame': 'Month 3, month 6, month 12', 'description': 'Bladder Control Scale (0-22) higher score meaning a worse outcome'}, {'measure': 'To assess bowel control', 'timeFrame': 'Month 3, month 6, month 12', 'description': 'Bowel Control Scale (0-22) higher score meaning a worse outcome'}, {'measure': 'To assess depression', 'timeFrame': 'Month 3, month 6, month 12', 'description': 'Patient Health Questionnaire-8 (0-12) higher score meaning a worse outcome'}, {'measure': 'To assess quality of life', 'timeFrame': 'Baseline, month 6, month 12', 'description': 'p-value of multivariate analysis for non-parametric data'}, {'measure': 'To assess disability', 'timeFrame': 'Baseline, month 6, month 12', 'description': 'Expanded Disability Status Scale (0-10), higher score meaning a worse outcome'}, {'measure': 'To assess satisfaction and user experience with the smartphone application and the web dashboard', 'timeFrame': 'Through study completion, 21 months', 'description': 'Descriptive analysis of satisfaction and user experience questionnaires (System Usability Scale (1-100) higher score meaning a better outcome)'}, {'measure': 'To assess at-home compliance and adherence to the patient application', 'timeFrame': 'Through study completion, 21 months', 'description': "Descriptive analysis of the mobile application's adherence data (number of completed questionnaires, number of sessions performed etc.)."}, {'measure': 'To compare results obtained with at home MVT and in-clinic OCT-scan', 'timeFrame': 'Through study completion, 21 months', 'description': "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"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['NMO', 'NMOSD', 'Neuromyelitis optica', 'Neuromyelitis optica spectrum disorder'], 'conditions': ['Neuromyelitis Optica']}, 'descriptionModule': {'briefSummary': "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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged over 18 years old\n* NMOSD as defined by the 2015 international consensus diagnostic criteria (AQP4+ only)\n* With NMOSD treatment (treatment must be unchanged since 6 months before enrollment, and 1 month for analgesics, antidepressants, neuroleptics)\n* EDSS =\\< 7\n* With no evidence of relapse in the past 3 months before enrollment\n* Who have read the information sheet and signed the informed consent form\n* Able to use a smartphone\n* Owns a personal smartphone which version is above 13 for IOS and 8 for Android included\n* Able to read language in which the mobile application is available and able to understand pictograms\n\nExclusion Criteria:\n\n* 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\n* Pregnant and nursing women\n* Person under guardianship or curatorship\n* Bedridden patients or patients with a daily activity of less than 2 hours per day\n* Current drugs or/and alcohol abuse that could influence performance on the tests (clinician's judgment)\n* 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."}, 'identificationModule': {'nctId': 'NCT05566769', 'acronym': 'OPTIS', 'briefTitle': 'Performance and Safety of a Digital Tool for Unsupervised Self-assessment of NMOSD', 'organization': {'class': 'OTHER', 'fullName': 'Ad scientiam'}, 'officialTitle': 'Performance and Safety of a Digital Tool for Unsupervised Self-assessment of Neuromyelitis Optica Spectrum Disorder', 'orgStudyIdInfo': {'id': 'OPTIS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NMOSDCopilot', 'description': 'Performance of digital tests and standard test in clinic at D0 and M6 Use of NMOSDCopilot at-home in between visits during 12 months', 'interventionNames': ['Device: NMOSDCopilot smartphone application']}], 'interventions': [{'name': 'NMOSDCopilot smartphone application', 'type': 'DEVICE', 'description': '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', 'armGroupLabels': ['NMOSDCopilot']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Dr Lilyana Amezcua', 'role': 'CONTACT', 'email': 'lamezcua@usc.edu', 'phone': '323 442-5710'}, {'name': 'Dr Amezcua', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Dr Apperson', 'role': 'CONTACT', 'email': 'mlapperson@ucdavis.edu', 'phone': '800 282 3284'}, {'name': 'Dr Apperson', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California Davis Health', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'John Ciotti, MD', 'role': 'CONTACT', 'email': 'jciotti@usf.edu', 'phone': '8133969478'}, {'name': 'Dr Ciotti', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of south Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '60201', 'city': 'Evanston', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Afif Hentati, MD', 'role': 'CONTACT', 'email': 'AHentati@northshore.org', 'phone': '+1 847-570-2570'}, {'name': 'Dr Hentati', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'NorthShore University HealthSystem', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Elias S Sotirchos', 'role': 'CONTACT', 'email': 'ess@jhmi.edu', 'phone': '410-614-1522'}, {'name': 'Dr Sotirchos', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Johns Hopkins Outpatient Center (now called Levi Watkins, Jr., M.D., Outpatient Center)', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michael Levy, MD, PhD', 'role': 'CONTACT', 'email': 'MLEVY11@mgh.harvard.edu', 'phone': '(617) 726-7565'}, {'name': 'Dr Levy', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Massachussets General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '63130', 'city': 'Washington', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Robert T Naismith, MD', 'role': 'CONTACT', 'email': 'naismithr@wustl.edu', 'phone': '314-362-3293'}, {'name': 'Dr Naismith', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Washington University in St. Louis', 'geoPoint': {'lat': 38.55811, 'lon': -91.01209}}, {'zip': '89106', 'city': 'Las Vegas', 'state': 'Nevada', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Le Hua, MD', 'role': 'CONTACT', 'email': 'Hual@ccf.org', 'phone': '7024836000'}, {'name': 'Dr Le Hua', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CC Lou Ruvo Center for Brain Health', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '27514', 'city': 'Chapel Hill', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Dr Dujmovic', 'role': 'CONTACT', 'email': 'irdujm@neurology.unc.edu', 'phone': '984 974-4401'}, {'name': 'Dr Dujmovic', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of North Carolina at Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gabriel Pardo, MD', 'role': 'CONTACT', 'email': 'gabriel-pardo@omrf.org', 'phone': '(405) 271-6673'}], 'facility': 'Oklahoma Medical Research Foundation', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '59037', 'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Helene Zephir, Pr', 'role': 'CONTACT', 'email': 'Helene.ZEPHIR@chu-lille.fr', 'phone': '03 20 44 59 62'}], 'facility': 'Hôpital Roger Salengro', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '13385', 'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Dr Maarouf', 'role': 'CONTACT', 'email': 'Adil.MAAROUF@ap-hm.fr', 'phone': '04.91.38.00.00'}, {'name': 'Dr Maarouf', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Marseille - La Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34295', 'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pierre Labauge, Pr', 'role': 'CONTACT', 'email': 'p-labauge@chu-montpellier.fr', 'phone': '04 67 33 94 69'}], 'facility': 'CHU de Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '06000', 'city': 'Nice', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Michael Cohen, Dr', 'role': 'CONTACT', 'email': 'cohen.m@chu-nice.fr', 'phone': '04 92 03 77 77'}], 'facility': 'Hopital Pasteur 2', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Elisabeth Maillart, Dr', 'role': 'CONTACT', 'email': 'elisabeth.maillart@aphp.fr', 'phone': '01 42 17 62 05'}], 'facility': 'Hopital La Pitié Salpétrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '76038', 'city': 'Rouen', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'France', 'facility': 'CHU Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '67000', 'city': 'Strasbourg', 'status': 'COMPLETED', 'country': 'France', 'facility': 'Hopital de Hautepierre', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '31059', 'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Dr Ciron', 'role': 'CONTACT', 'email': 'ciron.j@chu-toulouse.fr', 'phone': '+33 5 61 77 91 06'}, {'name': 'Dr Ciron', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Toulouse - Hôpital Purpan', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '01397', 'city': 'Dresden', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Dr Ziemssen', 'role': 'CONTACT', 'email': 'Tjalf.Ziemssen@ukdd.de', 'phone': '+49 (0) 351 458 7450'}, {'name': 'Dr Ziemssen', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Dr Inojosa', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Universitätsklinikum Carl Gustav Carus', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '45147', 'city': 'Essen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Dr Pul', 'role': 'CONTACT', 'email': 'refik.pul@uk-essen.de', 'phone': '+49 201 / 723- 82382'}, {'name': 'Dr Pul', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitätsklinik Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '80336', 'city': 'Munich', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Dr Havla', 'role': 'CONTACT', 'email': 'joachim.havla@med.lmu.de', 'phone': '+49 89 4400 74781'}, {'name': 'Dr Havla', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Dr Kumpfel', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Dr Gerdes', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Munich', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'city': 'Munich', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Achim Berthele, Dr', 'role': 'CONTACT', 'email': 'achim.berthele@tum.de', 'phone': '+49 89 41400'}], 'facility': 'Hopital Rechts der Isar der Technischen Universitat Munchen', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'centralContacts': [{'name': 'Dr Levy', 'role': 'CONTACT', 'email': 'mlevy11@mgh.harvard.edu', 'phone': '617-726-7565'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ad scientiam', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}