Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-25 @ 7:55 PM
Study NCT ID:
NCT03586635
Status:
COMPLETED
Last Update Posted:
2022-03-18
First Post:
2018-07-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Automated EDSS Score Calculation by Smartphone Application
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-09-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-17', 'studyFirstSubmitDate': '2018-07-02', 'studyFirstSubmitQcDate': '2018-07-12', 'lastUpdatePostDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'EDSS score apllication VS paper version', 'timeFrame': '6 months', 'description': 'comparison of the overall EDSS score obtained with the application and its paper version at the end of the neurological examination'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['MS CHRONIC PROGRESSIVE']}, 'descriptionModule': {'briefSummary': 'The EDSS score is the reference tool for rating disability in patients with multiple sclerosis. It is used in both daily monitoring and clinical research studies.\n\nIts main shortcoming lies in its imprecise and variable nature, with significant inter-examiner variability. This variability is the consequence of the complexity of the score rating and also of its subjective nature.\n\nThe application developed aims to reduce the risk of rating error, and to homogenize the results obtained regardless of the examiner and his experience in using the score.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '\\- patients coming to the MS Competence and Recovery Centre', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with multiple sclerosis seen at the Central Nervous System Day Hospital as part of their follow-up and requiring neurological examination.\n* Age ≥ 18 years\n* No opposition to the use of their data\n\nExclusion Criteria:\n\n\\- Neurological or general pathology, other than multiple sclerosis, that may interfere with EDSS score scoring'}, 'identificationModule': {'nctId': 'NCT03586635', 'acronym': 'Easy EDSS', 'briefTitle': 'Automated EDSS Score Calculation by Smartphone Application', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'Automated EDSS Score Calculation Using a Smartphone Application in Multiple Sclerosis Patients', 'orgStudyIdInfo': {'id': '18-PP-09'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with Multiple Sclerosis', 'interventionNames': ['Other: neurological exam']}], 'interventions': [{'name': 'neurological exam', 'type': 'OTHER', 'description': "Patients participating in the study are recruited from the investigator's tertiary multiple sclerosis management centre. They are systematically examined neurologically as part of their routine follow-up.\n\nthe patient will be exceptionally examined by two distinct persons, a senior doctor and a junior doctor (internal or external) independently.\n\nAt the end of the neurological examination, each examiner will evaluate the EDSS score in a classical way (using paper definitions) then using the smartphone application", 'armGroupLabels': ['Patients with Multiple Sclerosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06000', 'city': 'Nice', 'country': 'France', 'facility': 'Nice University Hospital', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}