Ignite Creation Date:
2025-12-24 @ 12:18 PM
Ignite Modification Date:
2026-04-15 @ 1:58 PM
Study NCT ID:
NCT05680961
Status:
UNKNOWN
Last Update Posted:
2023-01-11
First Post:
2022-06-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Monitoring Movement Disorder Symptoms With a Mobile Medical App on Off-the-shelf Consumer Mobile Devices
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008991', 'term': 'Monitoring, Physiologic'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-01-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2023-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-27', 'studyFirstSubmitDate': '2022-06-21', 'studyFirstSubmitQcDate': '2022-12-27', 'lastUpdatePostDateStruct': {'date': '2023-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "NeuroRPM UPDRS predicted score vs. clinical raters' UPDRS", 'timeFrame': 'Comparison will be performed upon completion of the study, approximately in 1 year.', 'description': 'We will compare symptom severity as predicted by NeuroRPM to UPDRS scores from clinical raters. Statistical significance will be evaluated by intraclass correlation and kappa-statistic.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ["Parkinson's disease"], 'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate whether New Touch Digital (NTD) NeuroRPM software installed on wearable devices can objectively measure and track symptoms in patients with Parkinson's disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "The study is open to persons 18 years of age and older with a clinical diagnosis of Parkinson's diseases without other neurological diseases.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subject is 18 years of age or older\n2. Subject is able to provide informed written consent\n3. Subject has been clinically diagnosed with Parkinson's Disease\n4. Subject is mentally and physically capable of performing tasks on the mobile device and related physical activities herein described\n\nExclusion Criteria:\n\n1. Inability to give informed consent\n2. Presence of additional neurological disease aside from the diseases being studied\n3. Inability to understand and follow the directions for the study"}, 'identificationModule': {'nctId': 'NCT05680961', 'briefTitle': 'Monitoring Movement Disorder Symptoms With a Mobile Medical App on Off-the-shelf Consumer Mobile Devices', 'organization': {'class': 'OTHER', 'fullName': "Parkinson's & Movement Disorders Center of Maryland"}, 'officialTitle': 'Monitoring Movement Disorder Symptoms With a Mobile Medical App on Off-the-shelf Consumer Mobile Devices', 'orgStudyIdInfo': {'id': 'NTD-101'}}, 'armsInterventionsModule': {'armGroups': [{'label': "Parkinson's patients", 'description': "Cohort of patients with clinical diagnosis of Parkinson's diseases with varied symptoms and severity.", 'interventionNames': ['Device: Monitoring Device']}], 'interventions': [{'name': 'Monitoring Device', 'type': 'DEVICE', 'description': 'Monitoring Device', 'armGroupLabels': ["Parkinson's patients"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '21075', 'city': 'Elkridge', 'state': 'Maryland', 'country': 'United States', 'facility': "Parkinson's & Movement Disorders Center of Maryland", 'geoPoint': {'lat': 39.21261, 'lon': -76.71358}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Parkinson's & Movement Disorders Center of Maryland", 'class': 'OTHER'}, 'collaborators': [{'name': 'New Touch Digital Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}