Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2026-02-25 @ 6:33 PM
Study NCT ID:
NCT02701803
Status:
COMPLETED
Last Update Posted:
2019-06-27
First Post:
2016-02-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Parkinson's KinetiGraph, PKG in Patients With Deep Brain Stimulation and Continuous Levodopa Infusion Therapy
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': 'ACTUAL', 'count': 8}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-25', 'studyFirstSubmitDate': '2016-02-12', 'studyFirstSubmitQcDate': '2016-03-02', 'lastUpdatePostDateStruct': {'date': '2019-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bradykinesia score', 'timeFrame': '6 months', 'description': 'BKS is summary of bradykinesia presented in PKG recordings, BKS, 0 - 50'}], 'secondaryOutcomes': [{'measure': 'Dyskinesia score', 'timeFrame': '6 months', 'description': 'DKS summary of dyskinesia presented in PKG recordings, DKS, 0 - 50'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ["Parkinson's Disease"]}, 'descriptionModule': {'briefSummary': "In this study the aim is to evaluate the outcome of deep brain stimulation (DBS) and continuous intraduodenal levodopa therapy in patients with advanced Parkinson' disease by using Parkinson's KinetiGraph™ device which is a movement and acceleration measuring device. In this study we also evaluate the usability of Parkinson's KinetiGraph™ device by comparing it with written patient diaries.", 'detailedDescription': "In this study the aim is to evaluate the outcome of deep brain stimulation (DBS) and continuous intraduodenal levodopa therapy in patients with advanced Parkinson' disease by using Parkinson's KinetiGraph™ logger (PKG) device which is a movement and acceleration measuring device.\n\nA measurement is done before and after the implantation of selected therapy. PKG will measure automatically in every two minutes the movement of selected limb (usually the more affected upper extremity) for six days. At the same time a patient will keep a written diary of his/her Parkinsonian symptoms. Diary and collected PKG data will be compared. PKG will also remind with vibration the patient of the time drug administration and the patient can confirm this with pressing a button on PKG. The collected data will be transmitted to a computer and analyzed mathematically to produce a visual graph of daily movements. The aim is to evaluate PKG's usability in measuring Parkinsonian symptoms and in evaluation the outcome of DBS and levodopa therapy. Main parameters in evaluation are bradykinesia score and dyskinesia score."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Study population is consisted of patients with advanced Parkinson's disease in HUH neurological clinic. The treatment decision of deep brain stimulation and/or continuous intraduodenal levodopa therapy is done clinically by the treating physician. The patients are enrolled in the study after the clinical decision is made.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient with diagnosed Parkinson's disease\n* Parkinson's disease is in advanced state (defined by the treating physician)\n* A good response with over 30 % improvement of scores in Unified Parkinson's disease rating scale part III in pre-DBS evaluation\n\nExclusion Criteria:\n\n* Age older than 70 years (this is a clinical exclusion criteria for DBS treatment)\n* No history of psychosis or depression (this is a clinical exclusion criteria for DBS and intraduodenal levodopa therapy)\n* No diagnosed dementia (this is a clinical exclusion criteria for DBS and intraduodenal levodopa therapy)"}, 'identificationModule': {'nctId': 'NCT02701803', 'briefTitle': "Parkinson's KinetiGraph, PKG in Patients With Deep Brain Stimulation and Continuous Levodopa Infusion Therapy", 'organization': {'class': 'OTHER', 'fullName': 'Hospital District of Helsinki and Uusimaa'}, 'officialTitle': 'Ambulatory Movement Registration in Patients With Deep Brain Stimulation and Continuous Intraduodenal Levodopa Therapy', 'orgStudyIdInfo': {'id': 'HospitalDHU'}}, 'armsInterventionsModule': {'interventions': [{'name': "Parkinson's KinetiGraph™ logger", 'type': 'DEVICE', 'description': 'Logger is recording device which records the movement and acceleration of upper extremity'}]}, 'contactsLocationsModule': {'locations': [{'zip': '00029', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'HUH Meilahti Hospital, department of neurology', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}], 'overallOfficials': [{'name': 'Eero Pekkonen, M.D., Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'HUH, Meilahti Hospital, department of neurology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital District of Helsinki and Uusimaa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Specialising physician', 'investigatorFullName': 'Maija Koivu', 'investigatorAffiliation': 'Hospital District of Helsinki and Uusimaa'}}}}