Ignite Creation Date:
2025-12-24 @ 4:52 PM
Ignite Modification Date:
2026-02-26 @ 6:52 AM
Study NCT ID:
NCT01534650
Status:
COMPLETED
Last Update Posted:
2017-02-23
First Post:
2012-02-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Movement Disorder Quantification Algorithm Development
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D020329', 'term': 'Essential Tremor'}, {'id': 'D014202', 'term': 'Tremor'}, {'id': 'D018476', 'term': 'Hypokinesia'}, {'id': 'D020820', 'term': 'Dyskinesias'}], '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'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-22', 'studyFirstSubmitDate': '2012-02-14', 'studyFirstSubmitQcDate': '2012-02-14', 'lastUpdatePostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-02-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Processed kinematics', 'timeFrame': 'During assessment', 'description': 'Motion data collected during various motor tasks will be processed and compared to video review.'}]}, 'conditionsModule': {'keywords': ['motion sensors', 'tremor', 'bradykinesia', 'gait', 'balance', 'dyskinesia'], 'conditions': ["Parkinson's Disease", 'Essential Tremor']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to collect kinematic motion data from subjects with movement disorders such as Parkinson's disease (PD) and essential tremor (ET) to develop and validate algorithms for quantifying motor symptoms such as tremor, bradykinesia (slowed movements), dyskinesias (sudden, involuntary movements), gait, and balance during standardized tasks and/or activities of daily living."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Residents of Northeastern Ohio with a movement disorder such as Parkinson's disease or essential tremor.", 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged 18 years or older\n* Clinical diagnosis of idiopathic Parkinson's disease or essential tremor\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Significant medical or psychiatric illness\n* Not capable of following the required clinical instructions\n* Serious medical conditions that compromise safety"}, 'identificationModule': {'nctId': 'NCT01534650', 'briefTitle': 'Movement Disorder Quantification Algorithm Development', 'organization': {'class': 'INDUSTRY', 'fullName': 'Great Lakes NeuroTechnologies Inc.'}, 'orgStudyIdInfo': {'id': 'GLNT-001'}}, 'contactsLocationsModule': {'locations': [{'zip': '44125', 'city': 'Valley View', 'state': 'Ohio', 'country': 'United States', 'facility': 'Great Lakes NeuroTechnologies Inc. Movement Disorders Laboratory', 'geoPoint': {'lat': 41.38783, 'lon': -81.60457}}], 'overallOfficials': [{'name': 'Dustin A Heldman, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Great Lakes NeuroTechnologies Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Great Lakes NeuroTechnologies Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}