Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2026-02-22 @ 5:09 PM
Study NCT ID:
NCT02028858
Status:
COMPLETED
Last Update Posted:
2016-06-27
First Post:
2014-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cannabis and Parkinson's Disease Tremor: A Natural History Study
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': 11}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-23', 'studyFirstSubmitDate': '2014-01-06', 'studyFirstSubmitQcDate': '2014-01-06', 'lastUpdatePostDateStruct': {'date': '2016-06-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent reduction in tremor as measured by Opal movement sensor', 'timeFrame': 'Upon enrollment, ongoing for 14 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ["Parkinson's Disease"]}, 'descriptionModule': {'briefSummary': "This is a prospective, observational study designed to describe the effects of Cannabis on Parkinson's Disease tremor.", 'detailedDescription': "Ten individuals with Parkinson's disease (PD) and tremor who use Cannabis were observed for two weeks. Individuals were asked to keep a journal of Cannabis use (form, delivery method, amount) and wear an accelerometer on the wrist with the dominant tremor. Analyses will be performed to describe whether Cannabis use affects PD tremor following use."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Primary Care Clinics; Washington State Parkinson's Disease Registry", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinical diagnosis of Parkinson's Disease\n* Presence of PD-related tremor\n* Currently using Cannabis for management of tremor\n* Obtaining Cannabis in accordance with Washington State law\n* Willing to log activities and experiences\n* Willing to wear a motion sensor\n* Able to attend 2 on-site visits\n\nExclusion Criteria:\n\n* Presence of active infection within 5 days prior to enrollment\n* Presence of unusual stressor within 5 days prior to enrollment\n* Pregnancy"}, 'identificationModule': {'nctId': 'NCT02028858', 'briefTitle': "Cannabis and Parkinson's Disease Tremor: A Natural History Study", 'organization': {'class': 'OTHER', 'fullName': 'Bastyr University'}, 'officialTitle': "Cannabis and Parkinson's Disease Tremor: A Natural History Study", 'orgStudyIdInfo': {'id': '13A-1339'}}, 'contactsLocationsModule': {'locations': [{'zip': '98028', 'city': 'Kenmore', 'state': 'Washington', 'country': 'United States', 'facility': 'Bastyr University', 'geoPoint': {'lat': 47.75732, 'lon': -122.24401}}], 'overallOfficials': [{'name': 'Laurie K Mischley, ND', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bastyr University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bastyr University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}