Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:53 PM
Study NCT ID:
NCT01356056
Status:
COMPLETED
Last Update Posted:
2013-03-12
First Post:
2011-05-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tele-diagnostics for Remote Parkinson's Monitoring
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'lastUpdateSubmitDate': '2013-03-11', 'studyFirstSubmitDate': '2011-05-17', 'studyFirstSubmitQcDate': '2011-05-18', 'lastUpdatePostDateStruct': {'date': '2013-03-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'UPDRS', 'timeFrame': 'Every 4 weeks'}, {'measure': 'PDQ-39', 'timeFrame': 'Every 4 weeks'}]}, 'conditionsModule': {'conditions': ["Parkinson's Disease"]}, 'descriptionModule': {'briefSummary': "The purpose of this research study is to design, implement, and clinically assess a portable, user worn system for monitoring Parkinson's disease (PD) motor symptoms. The current standard in evaluating symptoms is the Unified Parkinson's Disease Rating Scale (UPDRS), a subjective, qualitative ranking system. The main goal of this research is to develop a quantitative system, Kinesia HomeView, to assess tremor as well as different features of bradykinesia in a home based system which can capture those symptom changes over the course of a day and aid in evaluating treatment protocol efficacy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients with Parkinson's disease", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinical diagnosis of Parkinson's disease\n\nExclusion Criteria:\n\n* Inability to follow the required clinical instruction\n* Subjects with cognitive impairments that would prohibit them from properly using the Kinesia HomeView system\n* Subjects without the cognitive ability to respond to researchers and let them know when any parameters of the study may become uncomfortable\n* Subjects found on examination by our clinicians to have any physical limitations which would be counter productive to participation in this study."}, 'identificationModule': {'nctId': 'NCT01356056', 'briefTitle': "Tele-diagnostics for Remote Parkinson's Monitoring", 'organization': {'class': 'INDUSTRY', 'fullName': 'Great Lakes NeuroTechnologies Inc.'}, 'orgStudyIdInfo': {'id': '10-09-29-03EE'}, 'secondaryIdInfos': [{'id': '7R43NS065554-03', 'link': 'https://reporter.nih.gov/quickSearch/7R43NS065554-03', 'type': 'NIH'}, {'id': '5R43MD004049-02', 'link': 'https://reporter.nih.gov/quickSearch/5R43MD004049-02', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Kinesia HomeView Monitoring', 'description': 'Uses Kinesia HomeView at home once per week', 'interventionNames': ['Device: Kinesia HomeView']}, {'label': 'Control', 'description': 'Assessed in the clinic every 4 weeks using traditional methods'}], 'interventions': [{'name': 'Kinesia HomeView', 'type': 'DEVICE', 'description': 'Quantifies motor symptom severity in the home', 'armGroupLabels': ['Kinesia HomeView Monitoring']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45267', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Great Lakes NeuroTechnologies Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Cincinnati', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}