Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2025-12-25 @ 7:35 PM
Study NCT ID:
NCT04413032
Status:
COMPLETED
Last Update Posted:
2021-03-02
First Post:
2020-05-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
DreaMS - Digital Biomarkers for Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A group of patients with Multiple Sclerosis and a group of healthy volunteers will use the dreaMS App over the period of 6 weeks.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-02-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-01', 'studyFirstSubmitDate': '2020-05-12', 'studyFirstSubmitQcDate': '2020-05-29', 'lastUpdatePostDateStruct': {'date': '2021-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Test Reliability of digital biomarkers measured by Intra Class Correlation', 'timeFrame': '6 weeks', 'description': 'Number of digital biomarkers tested with an Intra Class Correlation of at least 0.6 if repeated 10 times'}, {'measure': 'Test Reliability of digital biomarkers measured by Coefficient of variation', 'timeFrame': '6 weeks', 'description': 'Number of digital biomarkers tested with a coefficient of Variation of less than 20% if repeated 10 times'}, {'measure': 'Determination of user acceptance of each digital biomarker with regards to acceptance based on a questionnaire using a likert scale', 'timeFrame': '6 weeks', 'description': 'Number of digital biomarkers tested with a good acceptance reflected by a mean response of more than 3 on a likert scale.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '36952010', 'type': 'DERIVED', 'citation': 'Pless S, Woelfle T, Naegelin Y, Lorscheider J, Wiencierz A, Reyes O, Calabrese P, Kappos L. Assessment of cognitive performance in multiple sclerosis using smartphone-based training games: a feasibility study. J Neurol. 2023 Jul;270(7):3451-3463. doi: 10.1007/s00415-023-11671-9. Epub 2023 Mar 23.'}, {'pmid': '36042020', 'type': 'DERIVED', 'citation': 'Woelfle T, Pless S, Reyes O, Wiencierz A, Feinstein A, Calabrese P, Gugleta K, Kappos L, Lorscheider J, Naegelin Y. Reliability and acceptance of dreaMS, a software application for people with multiple sclerosis: a feasibility study. J Neurol. 2023 Jan;270(1):262-271. doi: 10.1007/s00415-022-11306-5. Epub 2022 Aug 30.'}]}, 'descriptionModule': {'briefSummary': "The Investigators have developed the dreaMS App, a data communication platform collecting data from the patients' mobile devices (smartphone and wearables). Through the use of app-based tests, surveys and sensor data, the Investigators aim to identify novel types of clinical data that can be used as digital biomarkers with complementary clinical value as compared to the traditional diagnostic methods and techniques.\n\nIn this feasibility study a number of digital biomarkers will be applied to test their technical reproducibility/stability and meaningfulness to patients.", 'detailedDescription': "Multiple Sclerosis (MS) is a chronic inflammatory disease of the central nervous system (CNS) causing focal lesions of demyelination and diffuse neurodegeneration in the grey and white matter of the brain and spinal cord, leading to physical and cognitive disability. Currently there is a limited number of relevant biomarkers available in patients with MS, such as clinical, imaging or biological measures. Patient history and neurologic examination in combination with magnetic resonance imaging (MRI), evoked potentials and analysis of serum and cerebrospinal fluid (CSF) are the gold standard of diagnosis and mainly patient history, neurologic examination and MRI are used for patient monitoring. However, their prognostic value on a patient level is still very limited. Therefore, the scientific community and patients are in need for new and more reliable biomarkers, especially biomarkers of disease progression in order to adapt therapeutic approaches on an individual level. Digital biomarkers have the potential to fill this gap allowing for quasi-continuous measures that might be more informative than episodically collected conventional data concerning the impact of the disease on activities of daily living.\n\nThe Investigators have developed the dreaMS App, a data communication platform collecting data from the patients' mobile devices (smartphone and wearables). Through the use of app-based tests, surveys and sensor data, the Investigators aim to identify novel types of clinical data that can be used as digital biomarkers with complementary clinical value as compared to the traditional diagnostic methods and techniques.\n\nIn this feasibility study a number of digital biomarkers will be applied to test their technical reproducibility/stability and meaningfulness to patients and to select the most informative for the planned validation study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Patients with MS\n\nInclusion Criteria:\n\n* Age 18-70\n* Diagnosed with MS according to the revised McDonald criteria 2017, all clinical forms inclusive (CIS, RRMS, SPMS, PPMS)\n* EDSS ≤ 6.5\n* In possession of a smart phone\n\nExclusion Criteria:\n\n* Age \\<18 and \\> 70\n* EDSS \\> 6.5\n* Other clinically significant concomitant disease states (e.g., renal failure, severe hepatic dysfunction, severe/unstable cardiovascular disease, progressive cancer, etc.)\n* Known or suspected non-compliance, drug or alcohol abuse\n* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.\n* Women who are pregnant or breast feeding\n* Not in possession of a smart phone\n\nHealthy Volunteers\n\nInclusion Criteria:\n\n* Age 18-70\n* In possession of a smart phone\n\nExclusion Criteria:\n\n* Age \\<18 and \\> 70\n* Diagnosis of MS\n* Clinically significant concomitant disease states (e.g., renal failure, severe hepatic dysfunction, severe/unstable cardiovascular disease, progressive cancer, etc.)\n* Known or suspected non-compliance, drug or alcohol abuse\n* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.\n* Women who are pregnant or breast feeding\n* Not in possession of a smart phone'}, 'identificationModule': {'nctId': 'NCT04413032', 'acronym': 'DreaMS', 'briefTitle': 'DreaMS - Digital Biomarkers for Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Research Center for Clinical Neuroimmunology and Neuroscience Basel'}, 'officialTitle': 'DreaMS - Development of Digital Biomarkers in Multiple Sclerosis - Feasibility Study', 'orgStudyIdInfo': {'id': 'DreaMS_2020F'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with MS', 'description': '30 Patients with MS will use the DreaMS App over a study duration of 6 weeks.', 'interventionNames': ['Device: DreaMS']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy Volunteers', 'description': '30 Healthy Volunteers will use the DreaMS App over a study duration of 6 weeks.', 'interventionNames': ['Device: DreaMS']}], 'interventions': [{'name': 'DreaMS', 'type': 'DEVICE', 'description': "The dreaMS App is a data communication platform collecting data from the patients' mobile devices (smartphone and wearables). We analyze app-based tests, surveys and sensor data.", 'armGroupLabels': ['Healthy Volunteers', 'Patients with MS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'RC2NB', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Ludwig Kappos, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Basel and RC2NB'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Research Center for Clinical Neuroimmunology and Neuroscience Basel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}