Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2026-01-08 @ 2:04 AM
Study NCT ID:
NCT03845634
Status:
COMPLETED
Last Update Posted:
2020-07-08
First Post:
2019-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of a Non-Motor Fluctuation Assessment Instrument (NoMoFA) for Parkinson's Disease
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': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 202}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-09-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-07', 'studyFirstSubmitDate': '2019-02-07', 'studyFirstSubmitQcDate': '2019-02-15', 'lastUpdatePostDateStruct': {'date': '2020-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Cronbach's Alpha", 'timeFrame': 'Baseline', 'description': 'alpha 0 - 1.0'}, {'measure': 'Item-to-total correlation', 'timeFrame': 'Baseline', 'description': 'correlation -1.0 - 1.0'}, {'measure': 'Inter-rater reliability', 'timeFrame': '1 week after Baseline', 'description': 'kappa 0 - 1.0'}, {'measure': 'Concurrent validity', 'timeFrame': 'Baseline', 'description': 'correlation -1.0 - 1.0'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non-motor fluctuation'], 'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': "Investigators have developed a comprehensive questionnaire that assesses the presence of non-motor fluctuations (NMFs) in individuals with Parkinson's disease (PD). To date, 189 participants with PD have been assessed for preliminary data analysis prior to developing the penultimate version. At this time the objectives are to: (i) assess the scale's internal consistency and item-to-total correlations; (ii) assess test-retest reliability; (iii) use factor analysis and reliability measures to guide item reduction; (iv) assess construct validity; and (v) assess the scales ability to discriminate between static non-motor symptoms and non-motor symptoms which fluctuate (vi) estimate the relative distribution of cognitive, psychiatric, autonomic, sleep and sensory NMFs in PD patients with motor fluctuations and their impact on quality of life in Parkinson's disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Individuals, both men and women, who have been diagnosed with idiopathic Parkinson's Disease and have motor and non-motor fluctuating symptoms are invited to participate in the study. To ensure a representative sample, subjects spanning the disease spectrum will be equally represented in terms of mild, moderate and advanced symptoms of PD.", 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosed with Idiopathic Parkinson's Disease (according to the United Kingdom Parkinson's Disease Society Brain Bank clinical diagnostic criteria)\n* Stage of symptoms is mild, moderate or severe as per the Hoehn \\& Yahr scale\n* Have motor fluctuations\n* Have non-motor fluctuations\n\nExclusion Criteria:\n\n* Atypical Parkinsonism\n* Lack of motor fluctuations\n* Lack of English language proficiency in either subject or caregiver"}, 'identificationModule': {'nctId': 'NCT03845634', 'briefTitle': "Validation of a Non-Motor Fluctuation Assessment Instrument (NoMoFA) for Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Assistive Technology Clinic, Canada'}, 'officialTitle': "Validation of a Non-Motor Fluctuation Assessment Instrument (NoMoFA) for Parkinson's Disease", 'orgStudyIdInfo': {'id': '10-27'}}, 'contactsLocationsModule': {'locations': [{'zip': 'M6A 2E1', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Assistive Technology Clinic', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Galit Kleiner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistive Technology Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistive Technology Clinic, Canada', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Cincinnati', 'class': 'OTHER'}, {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, {'name': 'University of Michigan', 'class': 'OTHER'}, {'name': 'Rush University', 'class': 'OTHER'}, {'name': 'The Parkinson Study Group', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR'}}}}