Ignite Creation Date:
2025-12-24 @ 2:47 PM
Ignite Modification Date:
2026-02-19 @ 9:36 PM
Study NCT ID:
NCT03517059
Status:
COMPLETED
Last Update Posted:
2025-12-23
First Post:
2018-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Dysarthria, and the Appearance of Non-dopaminergic Signs in Idiopathic 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': 29}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2018-11-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2018-04-24', 'studyFirstSubmitQcDate': '2018-04-24', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the neural network between patients in OFF levodopa conditions and control subjects', 'timeFrame': 'Between two evaluation visits, on average at 3 months (baseline- 3 months)', 'description': 'Measure evaluated by functional MRI during the realisation of a cognitive task: symbol digit modality test'}], 'secondaryOutcomes': [{'measure': 'Change in the neural network between patients in OFF-drug conditions and healthy control subjects', 'timeFrame': 'Between two evaluation visits, on average at 3 months (baseline- 3 months)', 'description': 'Measure evaluated by functional MRI during the realisation of two motor tasks'}, {'measure': 'Change in the neural network between patients in OFF-drug conditions and healthy control subjects', 'timeFrame': 'Between two evaluation visits, on average at 3 months (baseline- 3 months)', 'description': 'Measure evaluated by resting state functional MRI'}, {'measure': 'Change in the neural network between OFF-drug condition and ON-drug condition in patients', 'timeFrame': 'Between two evaluation visits, on average at 3 months (baseline- 3 months)', 'description': 'Measure evaluated by functional MRI, during the realisation of one cognitive task and two motor tasks'}, {'measure': 'Change in the neural network between patients in OFF-drug conditions and neurological control subjects (with supra nuclear palsy)', 'timeFrame': 'Between two evaluation visits, on average at 3 months (baseline- 3 months)', 'description': 'Measure evaluated by functional MRI, during the realisation of one cognitive task and two motor tasks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Levodopa', 'axial symptoms'], 'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': "Pilot study:\n\n* Longitudinal follow up of the PRODY-GI cohort for parkinson's disease (PD)\n* Observational study of upper and lower axial symptoms' occurence in 30 PD patients in on and off drug conditions, 30 aged matched control subjects and 10 control subjects with supra nuclear palsy\n* Multi modal approach: functional MRI, clinical , ENT assessment, respiratory assessment, neuropsychological and gait evaluations", 'detailedDescription': 'Prospective, clinical assessment of :\n\n* Cognition and diadochokinetic task during fMRI in 30 PD patients (in off and on condition)\n* Motor assessment using VICON gait and balance analysis\n* Pulmonary functional testing in OFF and ON drug condition\n* Quality of life\n* Clinical neurological MDS UPDRS , N Fog questionnaire\n* ENT and speech therapist evaluation in OFF and ON drug condition'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients with Parkinson's disease (PD)", 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nParkinson's Disease group :\n\nPatients with Parkinson's Disease, who where included in the PRODYGI-1 cohort still meeting the MP criteria, Always followed in the service of neurology and pathology of the movement.\n\nPathological control group:\n\n* Patients suffering from Richardson syndrome.\n* Aged over 18\n\nHealthy control group:\n\n* Age-matched (± 5 years)\n* Recruited on the basis of volunteering.\n* free from any progressive neurological pathology after clinical examination and MoCA.\n\nExclusion Criteria:\n\nFor all groups:\n\n* Pregnant or lactating woman\n* Extra-neurological severe respiratory pathology\n* Terminal heart failure\n* Contraindication to MRI\n* Refusal / withdrawal / inability to give consent\n* ENT pathology."}, 'identificationModule': {'nctId': 'NCT03517059', 'acronym': 'Prodygi-II', 'briefTitle': "Study of Dysarthria, and the Appearance of Non-dopaminergic Signs in Idiopathic PARKinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': "Prospective Study of Dysarthria, and the Appearance of Non-dopaminergic Signs in Idiopathic PARKinson's Disease", 'orgStudyIdInfo': {'id': '2015_89'}, 'secondaryIdInfos': [{'id': '2016-A01544-47', 'type': 'OTHER', 'domain': 'ID-RCB number, ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'PD patients', 'description': '30 PD patients in ON and OFF levodopa conditions'}, {'label': 'Healthy control subjects', 'description': '30 age matched healthy control subjects'}, {'label': 'Neurological control subjects', 'description': '10 patients with defined supra nuclear palsy'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lille', 'country': 'France', 'facility': 'Hôpital Roger Salengro, CHRU', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Caroline MOREAU, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'collaborators': [{'name': 'France Parkinson Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}