Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2026-03-01 @ 4:45 PM
Study NCT ID:
NCT02051205
Status:
UNKNOWN
Last Update Posted:
2014-01-31
First Post:
2013-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Parkinson's Disease Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2017-03-24', 'releaseDate': '2017-02-05'}, {'resetDate': '2018-11-02', 'releaseDate': '2018-03-09'}], 'estimatedResultsFirstSubmitDate': '2017-02-05'}}, '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': 'ESTIMATED', 'count': 200}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-01-30', 'studyFirstSubmitDate': '2013-10-30', 'studyFirstSubmitQcDate': '2014-01-30', 'lastUpdatePostDateStruct': {'date': '2014-01-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cognitive function', 'timeFrame': '1 year', 'description': 'Rating with Mini-mental status examination (MMSE) and Cognitive abilities screening instrument (CASI)'}, {'measure': 'Quality of life', 'timeFrame': '1 year', 'description': 'Assessment with Parkinson disease questionnaire (PDQ-39), UPDRS part 2, and Schwab and England activity of daily living (SEADL)'}, {'measure': 'Depression', 'timeFrame': '1 year', 'description': "Assessment with Beck's depression inventory (BDI) and UPDRS part 1."}, {'measure': 'Comorbidity', 'timeFrame': '1 year', 'description': 'Hypertension, diabetes mellitus, stroke, cardiovascular disease, alcoholism, epilepsy, brain surgery, memory impairment, hallucination.'}, {'measure': 'Cost of medical treatment', 'timeFrame': '1 year', 'description': 'Identify individual medications and represented as levo-dopar equivalent daily dose (LEDD)'}, {'measure': 'Initial PD symptoms', 'timeFrame': '1 year', 'description': 'To identify the initial cardinal symptom: bradykinesia, tremor, rigidity and posture instability'}], 'primaryOutcomes': [{'measure': 'Risk factors', 'timeFrame': '1 year', 'description': 'risk factors include: pesticide, herbicide, drinking underground water, jobs with heavy metals exposure, tea drinking, coffee drinking, smoking, vegetarian'}], 'secondaryOutcomes': [{'measure': 'Motor function', 'timeFrame': '1 year', 'description': "Assessment with Unified Parkinson's Disease Rating Scale (UPDRS) part 3. Rating when l-dopa medication On and Off, to see the improvement %."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ["Parkinson's disease, risk factors, epidemiology"], 'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': "The purpose of the Parkinson's disease Registry (PDR) is to develop a nation-wide database of persons with Parkinson's disease (PD) in Taiwan.", 'detailedDescription': "Among degenerative neurological disease, PD is the second most common disorder. Although a wide range of incidence and prevalence rate exist in reviewed literatures due to a consequence of variation in study methodologies, the crude prevalence rate above 60 year-old is 1%. Increase in aging population will lead to an increase in PD patients. The PDR will be used to facilitate the understanding of basic epidemiological features of the disease, genetic and non-genetic risk factors, co-morbidity, the up-to-date treatment strategies and the related economic burden from medical and surgical treatment (deep brain stimulation), to develop new therapeutic protocols as well as healthcare policies, and ultimately, to improve the quality of life of PD patients. PDR will also be served as data bank for investigators in the field of PD to quickly identify and notify research subjects about other research studies for which they are eligible. Patient who registered can also sign their consent for a future brain donation after they passed away.\n\nMethods:\n\nThe 4 main Tzu Chi Hospitals from Hualien, Da Lin, Taichung, and Taipei will serve as representative of pilot study for National registry. This will be a record-based, multi-center, nation-wide, cohort study. A user-friendly, yet, encrypted registration platform will be provided through internet for authorized personnel. The contents of PDR will be as follow: demographic features, risk factors, clinical profiles of diagnostic criteria, co-morbidity, images profiles, treatment regimens in details, prognosis, health-related quality of life, and neuropsychological assessment batteries.\n\nExpected results:\n\n1. To facilitate the understanding of demographic epidemiological features of PD.\n2. To find the risk factors of PD and the possible intervention toward disease prevention in Taiwan.\n3. To find the comorbidity of the disease, and the solution toward better treatment and related outcome.\n4. Assess current treatment approaches and develop best-practice guidelines.\n5. Tracking the health-related quality of life of PD patient as well as care-givers and the economic impact from different treatment regimens of best medications versus surgical interventions (neuromodulation / neuro-regeneration) from time to time.\n6. Drive the development of innovative research projects.\n7. Accelerate the process of informing patients of research projects for which they may be eligible.\n\nKey words: Parkinson's disease, Registry, Epidemiology, Treatment, Prognosis"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients in community hospitals or medical centers', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinical diagnosis of Parkinson's disease\n\nExclusion Criteria:\n\n* None"}, 'identificationModule': {'nctId': 'NCT02051205', 'briefTitle': "Parkinson's Disease Registry", 'organization': {'class': 'OTHER', 'fullName': 'Buddhist Tzu Chi General Hospital'}, 'officialTitle': "Parkinson's Disease Registry（PDR）", 'orgStudyIdInfo': {'id': 'TCRD-I102-03'}, 'secondaryIdInfos': [{'id': 'TCRD-I102-03', 'type': 'OTHER_GRANT', 'domain': 'TCRD-I102-03'}]}, 'contactsLocationsModule': {'locations': [{'zip': '886', 'city': 'Hualien City', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Shin-Yuan Chen, M.D.', 'role': 'CONTACT', 'email': 'william.sychen@msa.hinet.net', 'phone': '886-3-8561825', 'phoneExt': '2151'}, {'name': 'Shin-Yuan Chen, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hualien Tzu Chi Hospital', 'geoPoint': {'lat': 23.97694, 'lon': 121.60444}}], 'centralContacts': [{'name': 'Tingwen Hou', 'role': 'CONTACT', 'email': 'tingwen.hou@msa.hinet.net', 'phone': '+886-3-8561825', 'phoneExt': '2151'}], 'overallOfficials': [{'name': 'Shin-Yuan Chen, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Neurosurgery, Hualien Tzu Chi Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Buddhist Tzu Chi General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Neurosurgery', 'investigatorFullName': 'Shin-Yuan Chen', 'investigatorAffiliation': 'Buddhist Tzu Chi General Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2017-02-05', 'type': 'RELEASE'}, {'date': '2017-03-24', 'type': 'RESET'}, {'date': '2018-03-09', 'type': 'RELEASE'}, {'date': '2018-11-02', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Shin-Yuan Chen, Department of Neurosurgery, Buddhist Tzu Chi General Hospital'}}}}