Ignite Creation Date:
2025-12-24 @ 1:50 PM
Ignite Modification Date:
2026-04-16 @ 9:26 PM
Study NCT ID:
NCT02060695
Status:
RECRUITING
Last Update Posted:
2017-05-03
First Post:
2014-02-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Temporal Relationship Between Motor Fluctuations and Nonmotor Fluctuations
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': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2031-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-02', 'studyFirstSubmitDate': '2014-02-03', 'studyFirstSubmitQcDate': '2014-02-10', 'lastUpdatePostDateStruct': {'date': '2017-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2030-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The proportion of participants with impulse control disorders', 'timeFrame': '6 months', 'description': 'The presence of impulse control disorders including excessive shopping, binge eating, pathologic gambling, and hypersexuality will be checked with questionnaire at 6, 12, 18, 24, 30, and 36 months in order to determine the frequency of impulse control disorders among the participants'}, {'measure': 'The proportion of participants with rapid eye movement (REM) sleep behavior disorder', 'timeFrame': '6 months', 'description': 'The presence of REM sleep behavior disorder will be checked with questionnaire at 6, 12, 18, 24, 30, and 36 months in order to determine the frequency of REM sleep behavior disorder among the participants.'}, {'measure': 'The proportion of participants with smoking history', 'timeFrame': '6 months', 'description': 'The smoking history will be checked with questionnaire at 6, 12, 18, 24, 30, and 36 months in order to determine the influence of the smoking history to development of motor/nonmotor fluctuation.'}], 'primaryOutcomes': [{'measure': 'time period from the onset of disease to the occurrence of motor or nonmotor fluctuation', 'timeFrame': '6 months', 'description': "The proportion of participants with motor and/or nonmotor fluctuation will be evaluated at 6, 12, 18, 24, 30, and 36 months after the enrollment of each participant in order to determine the time course of motor/nonmotor fluctuation in persons with early stage of Parkinson's disease."}], 'secondaryOutcomes': [{'measure': 'sensitivity and specificity of self-diagnostic questionnaire of motor/nonmotor fluctuation', 'timeFrame': '3 years', 'description': 'The participants will be checked regularly for the development of motor/nonmotor fluctuation during study period by both of self-diagnostic questionnaire and clinician. The validation of self-diagnostic questionnaire of motor/nonmotor fluctuation will be conducted compared to the clinician-evaluated occurrence of motor/nonmotor fluctuation.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Parkinson disease'], 'conditions': ['Parkinson Disease']}, 'referencesModule': {'references': [{'pmid': '12177375', 'type': 'BACKGROUND', 'citation': "Witjas T, Kaphan E, Azulay JP, Blin O, Ceccaldi M, Pouget J, Poncet M, Cherif AA. Nonmotor fluctuations in Parkinson's disease: frequent and disabling. Neurology. 2002 Aug 13;59(3):408-13. doi: 10.1212/wnl.59.3.408."}, {'pmid': '1654794', 'type': 'BACKGROUND', 'citation': 'Resnick RJ, Kole HK, Racker E. Multiple changes induced by cholera toxin contribute to the stimulation of aerobic lactate production in rat-1 fibroblasts. Arch Biochem Biophys. 1991 May 1;286(2):579-85. doi: 10.1016/0003-9861(91)90083-u.'}, {'pmid': '16897594', 'type': 'BACKGROUND', 'citation': "Stacy M, Hauser R. Development of a Patient Questionnaire to facilitate recognition of motor and non-motor wearing-off in Parkinson's disease. J Neural Transm (Vienna). 2007 Feb;114(2):211-7. doi: 10.1007/s00702-006-0554-y. Epub 2006 Aug 10."}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine the temporal relationship between motor fluctuations and non-motor fluctuations in persons with Parkinson's disease.\n\nObservational study case-only", 'detailedDescription': 'Objectives\n\n1. how many patients will experience motor or nonmotor fluctuation during follow-up period?\n2. in how many patients, does motor fluctuation precede nonmotor fluctuation?\n3. in how many patients, does nonmotor fluctuation precede motor fluctuation?\n\nParticipants: persons with Parkinson disease in early stage who does not have motor or nonmotor fluctuation\n\nRecruitment period: 3 years from the commencement of the study Follow-up period: 3 years for each participants'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'movement disorder clinic', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* clinical diagnosis of Parkinson disease by United Kingdom Parkinson's Disease Society Brain Bank criteria\n* early stage\n\nExclusion Criteria:\n\n* dementia (MMSE\\<26)\n* persons who refuse participating"}, 'identificationModule': {'nctId': 'NCT02060695', 'briefTitle': 'Temporal Relationship Between Motor Fluctuations and Nonmotor Fluctuations', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Temporal Relationship Between Motor Fluctuations and Nonmotor Fluctuations', 'orgStudyIdInfo': {'id': 'H-1109-081-378'}}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Beom S Jeon, MD, PhD', 'role': 'CONTACT', 'email': 'brain@snu.ac.kr', 'phone': '82-2-2072-2876'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Beom S Jeon, MD, PhD', 'role': 'CONTACT', 'email': 'brain@snu.ac.kr', 'phone': '82-2-2072-2876'}], 'overallOfficials': [{'name': 'Beom S Jeon, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'BS Jeon', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}