Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2026-02-26 @ 5:16 AM
Study NCT ID:
NCT03130595
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-11-27
First Post:
2017-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
West Sweden Parkinson Objective Measurement Registry Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}], 'ancestors': [{'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': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 320}, 'targetDuration': '15 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-04-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-26', 'studyFirstSubmitDate': '2017-04-22', 'studyFirstSubmitQcDate': '2017-04-22', 'lastUpdatePostDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective measurement of spontaneous movement patterns', 'timeFrame': '144 hours', 'description': 'Parkinson Kinetigraph'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['accelerometry', 'Parkinson Kinetigraph'], 'conditions': ['Parkinson Disease', 'Parkinsonism', 'Parkinsonian Disorders']}, 'descriptionModule': {'briefSummary': "WestPORTS will recruit a randomly selected population consisting of 25% of all individuals with Parkinson's disease (ICD G209) that have visited any of the seven major outpatient neurology or geriatrics clinics in West Sweden (population 1.7M) during a predefined 12 month period between Sept 2016 and April 2018.\n\nBaseline clinical and demographic data will be collected along with a 6 x 24h accelerometry recording using the Parkinson Kinetigraph (Global Kinetics). Repeated data collections will be made with regular intervals of up to 2 years as long as subjects are alive and willing.", 'detailedDescription': "The following data will be collected at baseline:\n\nDate of birth Handedness Family history of Parkinson's disease Time of first motor symptom onset Laterality of symptom onset Time of diagnosis Time of first pharmacological intervention (if applicable) First antiparkinsonian drug\n\nThe following data will be collected at every visit/update Current living conditions Current non motor complications Current medications Hoehn and Yahr staging Clinical Impression of Severity Index in Parkinson's disease (CISI-PD)\n\nPatient self assessments: PDQ8, NMS-Questionnaire, EQ5D-5L, Patient Reported Outcome in Parkinson's Disease (PRO-PD)\n\nParkinson Kinetigraph (PKG) accelerometry based recording of spontaneous movement patterns over a 6x24h period. The following indices will be extracted: median bradykinesia score (BKS), median dyskinesia score (DKS), Fluctuation Dyskinesia Score (FDS), Percent daytime with Immobility (PTI%), Percent daytime with tremor (PTT%).\n\nThe primary analysis will be descriptive and include demographic composition of the population, clinical characteristics and objective measurement data. In addition to indices a standardized qualitative assessment of PKG recordings will be made to identify motor fluctuations. Correlations between clinical ratings, patient reported outcomes, disease duration, age, medication and objective measurement indices will be studied\n\nIn the prospective phase of the study the development of objective movement recordings will be studied along with the development of clinical ratings and patient reported outcomes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '25% of the population described by the inclusion criteria', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Medical record with a G209 (Parkinson's disease) diagnosis\n* A visit to one of the participating outpatient clinics in West Sweden within the last 6 months\n* Informed consent\n\nExclusion Criteria:\n\n* Diagnosis revised before visit."}, 'identificationModule': {'nctId': 'NCT03130595', 'acronym': 'WestPORTS', 'briefTitle': 'West Sweden Parkinson Objective Measurement Registry Study', 'organization': {'class': 'OTHER', 'fullName': 'Sahlgrenska University Hospital'}, 'officialTitle': "West Sweden Parkinson Objective Measurement Registry Study - an Observational Cohort Study of the Prevalence and Development of Motor Symptoms Assessed With Automated Accelerometry in People With Parkinson's Disease in West Sweden", 'orgStudyIdInfo': {'id': 'WestPORTS'}, 'secondaryIdInfos': [{'id': 'PARKreg', 'type': 'REGISTRY', 'domain': 'Svenska Parkinsonregistret'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'PD outpatients in West Sweden', 'description': 'Cross-sectional random sample of patients with PD that have visited outpatient clinics in West Sweden in the last 6+6 months'}]}, 'contactsLocationsModule': {'locations': [{'zip': '41345', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Sahlgrenska University Hospital', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}], 'overallOfficials': [{'name': 'Filip Bergquist, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Göteborg University'}]}, 'ipdSharingStatementModule': {'url': 'http://www.neuroreg.se/', 'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'See plan description', 'ipdSharing': 'YES', 'description': 'Clinical registry data will be immediately available as part of the national Parkinson Registry. Study specific data from objective measurements will be made available within the registry one year after final subject has been recruited. Access to data requires ethical permission and permission from the registry scientific committee SWEPAR.', 'accessCriteria': 'Access to data requires ethical permission and permission from the registry scientific committee SWEPAR.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sahlgrenska University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Göteborg University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Filip Bergquist', 'investigatorAffiliation': 'Sahlgrenska University Hospital'}}}}